Generic drugs in the EU

Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval, etc.), obviously finalized by granting of a document also called marketing authorization (equivalent: product license). This process is performed within a legislative framework which defines the requirements necessary for application to the concerned (competent) regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria) and the grounds for approval or rejection of the application, and also the circumstances where a marketing authorization already granted may be withdrawn, suspended or revoked.NOTE [1]
The application dossier for marketing authorization is called New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in the European Union and other countries, or simply registration dossier. Basically, this consists of a dossier with data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyzes of finished product as described in that dossier. The content and format of the dossier must follow rules as defined by the competent authorities. For example, since year 2003, the authorities in the United States, the European Union and Japan ask for the Common Technical Document (CTD) format, and more recently, its electronic version – the electronic Common Technical Document (eCTD).

Marketing Authorisation

The application is filed with the competent drug regulatory authority in the concerned country, which can be either an independent regulatory body or a specialized department in the ministry of health.
In accordance with local legislation, the resulting document allowing to the applicant to market the product may be more detailed (in addition to data identifying the product and its holder it may contain addresses of all manufacturing sites, appended labeling, artwork of packaging components, etc.) until a one-page document called certificate of registration (and containing minimal data identifying the product and its source).
Many generic drugs are now being prescribed and the trend is increasing. For example, in Austria, the number of all generics prescriptions has more than doubled from 11% in 2000 to 23% in 2010. However, many myths and questions about generic drugs remain and information may be difficult to come by. It is therefore not surprising, as we have discovered in recent years, that even physicians and pharmacists are not always fully up to date in their understanding of generic drugs. Some of their questions centre on issues such as: are generic drugs really as good as the original; are we really dealing with an adequately tested, high quality medicinal product.
Today, generic drugs present an equally well-tolerated and efficacious alternative to established medicinal products, which contain well-known, rigorously tested active ingredients. An established originator product undergoes expensive and protracted development (up to 15 years) with inherently high preclinical and clinical research costs in order to be given market approval. The development of generic drugs, on the other hand, is relatively quick and inexpensive, which allows generic drugs to be sold at a distinctly cheaper price. This is due to the waiving of new preclinical and clinical studies, aside from some bioequivalence studies. Their lower price however should not be equated with ‘cheap quality’. In fact, generic medicines undergo the same strict scrutiny by the European or national medicines authorities as reference products.
 This marketing authorisation validates the safety, efficacy, and quality of a generic drug.

What makes a generic medicinal product generic?

The definition, according to Austrian drug law/the Medicinal Products Act as well as to EU Directive 2001/83/EC, is that a generic medicinal product ‘is a product which has the same qualitative’, i.e. kind of active substance, ‘and quantitative’, i.e. amount of active substance, ‘composition as the reference medicinal product’. For the sake of simplicity, the reference product is often also referred to as the originator. The different salts, esters, or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in their safety and/or efficacy properties. In these cases, the manufacturer of a generic drug has to submit further proof of efficacy and safety.
The pharmaceutical form, which means the distinct way a product is to be administered, of the generic medicinal product has to be the same as for the reference medicinal product [1]. However, remarkably the various types of immediate release oral pharmaceutical forms, e.g. tablets, capsules and dragées, are considered to be one and the same pharmaceutical form. A patient prescribed with a particular medicinal product may therefore be prescribed either a film-coated tablet or a capsule of the same drug by his physician. This in itself does not pose a problem, as the galenic formulation may indeed be different, but the impact on the safety and efficacy profile of the whole product has been judged to be comparable during the approval procedure.

Are different compositions possible?

Differences in composition between the generic and reference medicinal product are possible, but only regarding the excipients, e.g. bulking agents, colouring agents; and not for the active substances. For example, corn starch may be used instead of lactose as an excipient. However, it has to be demonstrated by the applicant of the generic drug that these differences in composition do not influence the therapeutic efficacy and safety or how the drug is absorbed, distributed, metabolised or eliminated by the body, i.e. the drug’s pharmacokinetics must also remain more or less the same.
Bioavailability or bioequivalence trials need to be conducted in order to demonstrate the equivalence between the generic medicinal product and the reference medicinal product. Differences in the manufacturing process compared to the originator are allowed, but the same strict general quality criteria, e.g. controlled production under good manufacturing practice (GMP), apply to the production of the generic medicinal product as well as for the reference product.
Also a medicinal product can only be considered as the reference product if it has been granted market approval in at least one Member State of the European Economic Area. However, only the so-called originator can serve as the reference product in bioequivalence testing, but never another generic drug, as this would otherwise mean the allowance of a copy of a copy.

How soon can generic medicinal products appear on the market?

The applicant needs to provide proof that the originator product has been authorised for at least eight years, or that the originator company has issued a written informed consent stating that the generics company is permitted to apply for its generic drugs sooner. As a rule however, the earliest a generic medicinal product is allowed to go on sale is 10 years after the first European originator is granted marketing authorisation. This 10-year market exclusivity can be extended by an additional year if, during the first eight years, the marketing authorisation holder of the originator obtains an additional authorisation for one or more new relevant therapeutic indications [2]. Figure 1 shows the ‘8+2 (+1) Formula’ applicable to generic medicinal products entering the market.
Some originators, however, hold patents—in some cases up to 1,000 patents for one single product were found—which can further postpone the launch of a generic drug. Such delay in market access is therefore possible, even if the marketing authorisation has already been granted to the generic drug. Notably, some misuse of patent strategies was described in the final report of the 2009 sector inquiry of the European Commission for Competition [3]. In a sample of 219 molecules from 2000 to 2007 there were reportedly 1,300 patent-related out-of-court disputes related to the launch of a generics.
The number of patent litigations brought to court totalled nearly 700 cases in these seven years and the number of cases increased by a factor of four between 2000 and 2007. The report reached the conclusion that the behaviour and practices of originators contribute to generics delay as well as to difficulties in innovation itself because originators may even block each other.

What is a bioequivalence study?

Bioequivalence studies are often the demanded basis for granting marketing authorisation for a generic medicinal product. They are clinical studies conducted in accordance with Austrian drug law as well as to EU Directive 2001/20/EC and provide data to demonstrate bioequivalence between a test product, i.e. the generic medicinal product, and a reference product, i.e. the originator.
The rate and extent of absorption of the medicinal products and therefore the bioavailability of the active substance(s) are determined. It is a widely accepted regulatory assumption, even sometimes challenged by generics disputants, that equivalent plasma concentration time curves represent equivalent efficacy and safety. Therefore, if bioequivalence can be shown after the administration of the same molar dose, equivalence or assumption of so-called essential similarity of the two products in terms of efficacy and safety can be concluded.

What are the rules for conducting bioequivalence studies?

How exactly a bioequivalence study has to be conducted, and which requirements need to be taken into consideration, is laid out in detail in the European bioequivalence guideline, the revised version of which came into effect mid-2010. The guideline clearly specifies the requirements for the design, conduct, and evaluation of bioequivalence studies for all EU countries. Since 2001, when the first bioequivalence guideline was published, many additional aspects were identified which needed to be amended and improved. Minor issues were addressed in interim question and answer documents.
After a three-year preparation period, the comprehensively revised version of the guideline came into effect in August 2010. The comments and suggestions of over 50 expert organisations and associations were worked into the 22 draft versions. The revised version therefore now reflects the most up-to-date state of knowledge, which is essential in issuing harmonised and standardised marketing authorisations across Europe.
The aim of the guideline was to do away with the ambiguities of the past, which often led to lengthy discussions and differences in professional opinion between the countries and competent authorities of the EU. This also ensures the safety and efficacy of all generic drugs being granted marketing authorisation.

Are bioequivalence studies only used in the development of generic drugs?

Since the task of bioequivalence studies is to detect differences between formulations or pharmaceutical forms, they are indeed not only used as a basis for the licensing of generic medicinal products. In fact, originators may also use bioequivalence studies during their own development since the formulation first used in clinical trials is often not the same which later goes into large-scale market production. Bioequivalence studies are used in these cases to allow bridging of the results obtained in the clinical trials. The same principles in study conduct, data evaluation, and assessment of results by the authority are applied in such originator studies as in the above-described studies for generic drugs. Remarkably, essential similarity between an originator small-scale clinical trial product and a large-scale originator product later to be for sale has never been put in question by anyone. Considering media coverage sometimes casts massive doubt about generics and the way they are authorised, obviously there seems to be an unfounded contrast in the perception dependent on who—the originator company or the generics company—makes use of the bio – equivalence concept for the authorisation of one of their products. Assuming that the bioequivalence concept is valid and trustworthy for authorisation of a new originator product, the same should be applied to the authorisation of a generic drug.

Is the manufacturing quality the same for generic and originator products?

The same quality requirements apply to the manufacturing of generic drugs as for any other medicinal product. Production has to be performed in accordance with GMP and is strictly controlled by evaluating the manufacturing data and by inspections performed not only in Austria and the EU, but also all over the world including countries such as India and South Africa. As for any other medicinal product, quality deficiencies in individual batches are theoretically possible and therefore the Austrian Federal Office for Safety in Health Care as well as the other competent EU authorities closely monitor the quality of all authorised medicinal products on the market. This is achieved by the legal obligation of authorisation holders to inform the authority about every out-of-specification results or other problems in manufacturing and an additional quality-defect notification system involving all healthcare professionals. This guarantees that only high quality medicinal products are available, regardless of whether these products are originators or generics.

When is a generic drug granted market authorisation?

An Austrian or an EU marketing authorisation is only issued when the pharmacokinetic parameters of the generic drug are comparable to those of the reference product and bioequivalence has been successfully demonstrated.
Furthermore, the overall benefits of the generic medicine need to outweigh its risks (positive risk–benefit ratio) and its excipients and the manufacturing process must have been demonstrated to not negatively influence its safety and efficacy.
Last but not least, all internationally relevant quality standards and legal requirements have to be fulfilled before marketing authorisation can be granted.

Procedures for obtaining a marketing authorization

Authorization processes follow either a purely national procedure, with rules and requirements as per national legislation in force, as it occurs in most of countries worldwide, or should follow a centrally approval or a mutual recognition or decentralized procedure within the European Union.

Types of applications

The type of application may vary according to status of the active ingredient.
Thus, if the application concerns a new active ingredient (new active substance, new chemical entity, new molecular entity), one talks about a full application.
Once a new active ingredient authorized, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations (changes to the existing marketing authorization) and extensions shall also be granted an authorization or be included in the initial marketing authorization, being subject of an abridged application.NOTE [2]
Special consideration is to be given to application for authorization of biological products and biotechnology products,[1] homeopathic products, herbal drugs, radionuclide generators, kits, radionuclide precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals; in such instances, requirements are specific, in the meaning that they are special, more or less detailed, as per the nature of active ingredient.

Validity of marketing authorizations

In most countries, a marketing authorization is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorization, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable. However, in the European Union, after one renewal, the marketing authorization shall remain valid for an unlimited period, unless the competent regulatory authority decides otherwise.NOTE [3]
If the marketing authorization is not renewed in a due time as requested by the local legislation, in order to maintain the pharmaceutical product on a market, one can apply for re-authorization (re-registration). In such situations, the applicant may be requested to submit the whole items necessary for a full application.
Marketing authorization may be withdrawn, suspended, revoked or varied by regulatory authorities if under normal conditions of use the benefit over risk ratio is no more favorable, the product is harmful, or if it lacks therapeutic efficacy; also, one of the above actions can be taken if the qualitative and quantitative composition or other qualitative aspects (control) are not as currently declared.
Marketing authorization may be also withdrawn, suspended or revoked if the marketing authorization holder or its representative does not fulfill other legal or regulatory obligations necessary to maintaining of product on the market, as per the legislation in force.
Also, the marketing authorization is withdrawn in the EU if the product is not placed on the market within next 3 consecutive years after granting of authorization or if it is no more marketed for 3 consecutive years (so-called “sunset clause”).NOTE [4]


  1. Jump up to:a b
  2. Jump up^ Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal of the European Union, L 311, 28.11.2001, p. 67.
  3. Jump up^ Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. L 136, 30.4.2004, p. 34.
  4. Jump up^ CMD(h) Agreement on Sunset Clause and its application to MAs granted in more than one Member State. Co-ordination Group for Mutual Recognition and Decentralised Procedures -Human, December 2006.
  1. European Medicines Agency. CPMP/EWP/QWP/1401/98 Rev.1. Guide line on the investigation on bioequivalence. Available from:
  2. European Commission. Guidance on elements required to support the significant clinical benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period, 2007. Available from:
  3. European Commission Competition, EU Sector inquiry, 8 July 2009. Available from:
  4. Tschabitscher D, Platzer P, Baumgärtel C, Müllner M. Generic drugs: quality, efficacy, safety and interchangeability. Wien Klin Wochenschr. 2008;120:63-9.
  5. American Medical Association. Summaries and recommendations of Council on Scientific Affairs Reports. Generic drugs (CSA Rep 6, A-02). 2002 Annual Meeting of the American Medical Association. 2002:13-4.
  6. Henney JE. Review of generic bioequivalence studies from the food and drug administration. JAMA. 1999;282:1995.
  7. Nwakama PE. Generic drug products demonstrate small differences in bioavailability relative to brand name counterparts: review of approved ANDAs, FDA. 2005.
  8. Davit BM, et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the FDA. Ann Pharmacother. 2009 Oct; 43(10):1583-97.
  9. Statement of the Austrian Society of Cardiology (ÖKG) regarding Clopidogrel-Generics. 2010. Available from:
  10. Consensus statement of Austrian Society of Biologic Psychiatry (ÖGBP), Generics and originators in psychiatry, 2008. Available from:

Intellectual Property (IP) Value Realization

IP-driven companies thoroughly and vigorously develop a Technology Value Realization (IP Commercialization) process to a level of sophistication such that they can predict with a reasonably high degree of accuracy the market success for their emerging technologies. This process links the stages of moving a technology with product potential to patent procurement/ management. In the four phases of technology commercialization, there are parallel patent value realization activities.

Bringing Patent Protected Technology to Market
The process begins in the Research & Development (R&D) labs where technology with product potential is identified. It is at this early point that the linkage with the patent process is formed.
Commercialization Process Patent Process
  I. Technology Analysis Process   I. Patent Search
  • Starts with an analysis of the technology followed by the development of a draft Technical Product Description
  • Patent searches are done for prior art
  • Provisional patents may be filed
  II. Market Opportunity Identification   II. Patent Application
  • Market opportunity identification
  • Competitive analysis
  • Draft Business Case
  • Final Technical Product Description
  • Initial patent value determination is made
  • Patent application is registered with the Patent and Trademark offices of the US (and other countries) for value added features
  • Patent Issued (or rejected)
  III. Market Actualization Planning   III. Patent Profit Planning
  • Most effective method(s) for value realization/commercialization are determined
  • Develop licensing strategies and Patent Licensing Agreements (PLAs)
  IV. Implementation   IV. Patent Management
  • Commercialization and appoint of a Product Manager (or market manager) to transition the technology into implementation and bring it to market
  • Associated patent(s) are then moved into Patent Management

Tuesday, 27 January 2015


The Paris Convention, signed in 1883 was one of the first IP treaties and now has over 170 signatory countries of which the US is one. The fundamental benefit of this treaty is that the filing date of a patent application filed in any one of the convention countries can serve as the priority date for patent applications filed within one year in any other member country. There are other treaties with similar reciprocal priority rights. The US, for example, has one with Taiwan.

The Paris Convention
As we discussed, the Paris Convention is an international treaty that allows applicants to file a first application in their home country. That application is referred to as a priority document or filing, and the date it is filed is called the priority date.
The priority filing starts a 12-month period within which a further application called a Paris Convention application (or a direct application claiming priority) can be filed elsewhere, claiming Paris Convention priority back to the priority date. To the extent that the content of the Paris Convention application is disclosed in the earlier priority document, it will be backdated to the priority date.
The advantages of using the Paris Convention are well known to those familiar with the patent process. The 12-month convention period lets the applicant seek funding, perform market research and turn an idea into a commercial product. All of these can be done following a single filing without risking a loss of rights in other countries.
If the Paris Convention didn’t exist, applicants would need to coordinate simultaneous filing in all countries that are of potential interest at the very start of the process. This would be complicated and costly, bearing in mind the need for translations in many countries.
– See more at:

The Paris Convention
As we discussed, the Paris Convention is an international treaty that allows applicants to file a first application in their home country. That application is referred to as a priority document or filing, and the date it is filed is called the priority date.
The priority filing starts a 12-month period within which a further application called a Paris Convention application (or a direct application claiming priority) can be filed elsewhere, claiming Paris Convention priority back to the priority date. To the extent that the content of the Paris Convention application is disclosed in the earlier priority document, it will be backdated to the priority date.
The advantages of using the Paris Convention are well known to those familiar with the patent process. The 12-month convention period lets the applicant seek funding, perform market research and turn an idea into a commercial product. All of these can be done following a single filing without risking a loss of rights in other countries.
If the Paris Convention didn’t exist, applicants would need to coordinate simultaneous filing in all countries that are of potential interest at the very start of the process. This would be complicated and costly, bearing in mind the need for translations in many countries.
– See more at:
The Paris Convention

Marketing Authorisation in Europe

European Commission logo

Authorisation Procedures for medicinal products

Procedures for evaluating medicinal products and granting marketing authorisation

The European system for the authorisation of medicinal products for human and animal use was introduced in January 1995 with the objective of ensuring that safe, effective and high quality medicines could quickly be made available to citizens across the European Union.
The European system offers several routes for the authorisation of medicinal products:
  • The centralised procedure, which is compulsory for products derived from biotechnology, for orphan medicinal products and for medicinal products for human use which contain an active substance authorised in the Community after 20 May 2004 (date of entry into force of Regulation (EC) No 726/2004) and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders or diabetes. The centralised procedure is also mandatory for veterinary medicinal products intended primarily for use as performance enhancers in order to promote growth or to increase yields from treated animals.
    Applications for the centralised procedure are made directly to the European Medicines Agency (EMA) and lead to the granting of a European marketing authorisation by the Commission which is binding in all Member States.
  • The mutual recognition procedure, which is applicable to the majority of conventional medicinal products, is based on the principle of recognition of an already existing national marketing authorisation by one or more Member States.
  • The decentralised procedure, which was introduced with the legislative review of 2004, is also applicable to the majority of conventional medicinal products. Through this procedure an application for the marketing authorisation of a medicinal product is submitted simultaneously in several Member States, one of them being chosen as the “Reference Member State”. At the end of the procedure national marketing authorisations are granted in the reference and in the concerned Member States.
Purely national authorisations are still available for medicinal products to be marketed in one Member State only.
Special rules exist for the authorisation of medicinal products for paediatric use, orphan drugs, traditional herbal medicinal products, vaccines and clinical trials.

The EMA and the authorisation procedure

In 1993 the European Medicines Agency (EMA) was founded with the primary task of providing scientific advice of the highest possible quality to the Community Institutions on all matters relating to medicinal products for human and veterinary use. EMA’s main task is to co-ordinate the scientific evaluation of the safety, efficacy and quality of medicinal products which undergo either procedure. All scientific questions arising in these procedures are dealt with by the EMA.
The agency has today established itself as a world-leading agency for the evaluation of medicinal products. It constitutes a major asset in making Europe an attractive location for new pharmaceuticals and allows for speedy and robust authorisation of new innovative medicines.
EMA’s key tasks are to:
  • provide Member States and Community institutions with the best possible scientific advice on questions about the quality, safety and efficacy of medicinal products for human and veterinary use;
  • establish a pool of multinational scientific expertise (by mobilising existing national resources) in order to achieve a single evaluation via the centralised or mutual recognition marketing authorisation procedures;
  • organise speedy, transparent and efficient procedures for the authorisation, surveillance and where appropriate, withdrawal of medicinal products in the EU;
  • advise companies on the conduct of pharmaceutical research;
  • reinforce the supervision of existing medicinal products (by co-ordinating national pharmacovigilance and inspection activities);
  • create databases and electronic communication facilities as necessary to promote the rational use of medicines.

What is a Marketing Authorisation needed for?


Orphan Medicinal Product Designation in the EU

What is an Orphan Medicinal Product?



Data exclusivity for medicinal products in Europe…8+2+1 approach


Data exclusivity for medicinal products in Europe

The pharmaceutical sector is heavily regulated, with significant costs associated with both developing a new medicinal product and generating the data required to get a product to market. Protecting that data is therefore important.  Data exclusivity is a form of product exclusivity right for medicinal products in Europe, and market exclusivity is a related form of additional protection.
These two rights are in addition to any granted patent exclusivity right covering a medicinal product.

Why is data exclusivity granted?

The rationale for granting data and market exclusivity is to compensate the innovator company for the investment it has put in to developing the new medicinal product and to generating the data required to obtain a marketing authorisation.
Regulatory approval for medicinal products requires applicants to provide information about the efficacy and safety of their product to regulatory authorities. The first applicant for approval of a new medicinal product must provide a substantial body of data relating to the product (including the results of pre-clinical tests and clinical trials).
The regulatory regime permits generic companies, who subsequently wish to gain their own approval for the same drug substance, to rely on information filed by the innovator company that made the first application.  In order to be able to benefit from the data provided by the innovator in their regulatory filings for that medicinal product – the “reference medicinal product” – a generic company must show that their product has the same qualitative and quantitative composition as that product and that it is bioequivalent.

So what is the impact of a product enjoying “data exclusivity”?

An innovator company enjoys a period of “data exclusivity” during which their pre-clinical and clinical trials data may not be referenced in the regulatory filings of another company(typically a generic company) for the same drug substance.
For marketing authorisation applications made from November 2005 onwards, the period of data exclusivity in Europe has been harmonised as 8 years from the date of first authorisation in Europe.  For marketing authorisation applications made before November 2005, the period of data exclusivity varies from EU member state to EU member state, and is either 6 years or 10 years.
For marketing authorisation applications made from November 2005 onwards, there is an additional period of 2 years of “market exclusivity“.  This is the period of time during which a generic company may not market an equivalent generic version of the originator’s pharmaceutical product (although their application for authorisation may be processed during this period, such that they are in a position to market their product on the expiry of this additional 2 year period).

An extra year of protection for new indications

As noted above, the rules determining exclusivity changed in 2005. Under the “old rules” data exclusivity lasted either 6 or 10 years. The “new rules” follow an “8 + 2 + 1” year approach:
“Under the ‘old rules’ data exclusivity lasted up to 10 years. The ‘new rules’ follow an ‘8 + 2 + 1’ year approach.”
  • During the first 8 years from the grant of the innovator company’s marketing authorisation, data exclusivity applies.
  • After the 8 years have expired a generic company can make use of the pre-clinical and clinical trial data of the originator in their regulatory applications, but still cannot market their product.
  • After a period of 10 years from the grant of the innovator company’s marketing authorisation, the generic company can also market their product, unless the innovator product qualifies for a further one year of exclusivity.
  • This additional 1 year may be obtained in a number of circumstances, such as where the innovator company is granted a marketing authorisation for a significant new indication for the relevant medicinal product. In such a situation the generic company can only market their product after 11 years from the grant of the innovator company’s marketing authorisation.
How to Calculate Data Exclusivity Periods in Europe
An application for approval of a New Chemical Entity must contain data to allow assessment of the safety and efficacy profile. These data include pharmacological and toxicological tests and the results of clinical trials.
To avoid repeating such tests and trials, applications for generic pharmaceutical substances are not required to include these data; instead they may rely on the data provided in relation to the NCE application. However, EC directive 2001/83/EC prevents regulatory authorities from accepting applications for approval of generics that rely on this data until a data exclusivity period has expired.
This period starts on the day of the first marketing authorisation in the European Community (including Liechtenstein/Switzerland), and expires either six or ten years thereafter, depending on the country in which the application is to be filed and the procedure used to file it.
Data exclusivity relates to the active ingredient per se, new periods of data exclusivity are not applied to later approval of new dosage forms, routes of administration or indications. 1) To calculate the expiry of the data exclusivity period for centralised applications add 10 years to the corresponding European First Marketing Authorisation Date shown in the Pipeline Selector Report. 2) To calculate the expiry of the data exclusivity period for national or mutual recognition procedure applications, add the term from the following table to the corresponding European First Marketing Authorisation
Exclusivity …….Period ………..Country
10 Years
Belgium (BE) France (FR) Germany (DE) Italy (IT) Luxembourg (LU) Netherlands (NL) Sweden (SE) United Kingdom (UK)
6 years
Austria (AT) Denmark (DK) Finland (FI) Greece (GR) Iceland (IS) Ireland (IRL) Norway (NO) Portugal (PT) Spain (ES) Other, acceding countries*
* Poland has a data exclusivity period of 3 years for approvals prior to 1/5/2004 and 6 years thereafter. Hungary, Slovenia, Slovakia and Malta have requested transitional data exclusivity periods.
New Data Exclusivity Provisions for Europe A New Data protection directive (2004/27/EC) has been introduced in Europe, which provides eight years of protection from the first European Community marketing authorisation date, after which a European regulatory body may accept an application for approval of a generic. However, the product may not be marketed within ten years of the first European Community marketing authorisation date. An additional one year period of data exclusivity is allowed in respect of new indications with ‘significant clinical benefit’ over the existing indications. Approvals for other product line extensions, including different pharmaceutical forms, are regarded as a bundle of approvals for which only one data exclusivity period is available. This new directive applies only to data relating to NCE products submitted for approval after 31 October 2005, hence do not affect any of the current Pipeline Patent Intelligence products.

Generic applications in the EU, patents and exclusivity

Types of protection on the originator molecule that have to be taken into account by generic drug manufacturers when filing applications for generic drugs in the EU include the following:
  • patents at the time of marketing
  • supplementary protection certificates at the time of marketing
  • data/regulatory exclusivity at the time of regulatory submission
  • market exclusivity at the time of marketing.
Patents in the EU last for 20 years. Pharmaceutical products are normally covered by a number of patents, sometimes by as many as 30 to 40 patents or more. For pharmaceuticals these patents can be extended with a maximum of five years via a supplementary protection certificate.
A patent on a new use or ‘indication’, formulation, salt or ester can block the registration or marketing of a generic medicine for treatments where the original patent has already expired. This strategy is known as ‘evergreening’ aims to prevent or delay competition from generic medicines by extending market protection through patents on minor changes to the original product.
Data exclusivity
Data exclusivity is a separate and additional provision to patent protection for the originator medicine. With data exclusivity, there can be neither disclosure of regulatory data to a competitor nor regulatory reliance upon the data. Data exclusivity is the period during which no generic drug application can take place.
Therefore, generic medicines can only be evaluated and approved by the medicines regulatory authorities after the data exclusivity period has expired.
In the EU there is now an 8+2(+1) formula for data and marketing exclusivity, which means that originator’s data is protected for 8 years and they have marketing exclusivity for a maximum of 11 years from first marketing approval in the EU.
Exclusivity period: 8+2(+1)
The 8+2(+1) exclusivity period came into effect in the EU in late 2005.
8 years data exclusivity dating from the European Commission authorisation decision: before that, no generic applications may be filed.
+2 years marketing protection: no generic applications may be approved.
+1 year: new indication(s) if it constitutes a significant clinical benefit.
It applies for all products, regardless of whether they followed a centralised or national approval procedure.
It is not retroactive; it does not affect exclusivity periods for products for which applications were submitted before the effective date—late 2005.
Market exclusivity
With marketing exclusivity, the agency cannot allow a competing product to enter the market during the time period in which an innovator has a right of exclusivity.
Submission of generic applications is only possible after the expiry of the data exclusivity at year 8. However, there is no linkage of patent protection with registration. Approval of the application and launch of the generic can then take place at year 10 if there is no patent protection, and if there is no additional 1 year of marketing exclusivity due to a significant new indication registered for the reference product during the first 8 years of license, see figure below.


Sandoz’s Zarzio (filgrastim) would be the first ‘biosimilar’ drug available in the US

New Drug Approvals

Neupogen vial and syringe

A key advisory committee of the US Food and Drug Administration (FDA) has voted in favour of licencing a copycat version of a biological drug. If approved, Sandoz’s Zarxio (filgrastim) would be the first ‘biosimilar’ drug available in the US.

read at……..

On 7 January, the FDA’s Oncological Drugs Advisory Committee unanimously cleared Sandoz’ version of filgrastim – marketed as Neupogen by Amgen – for all five indications approved for the Amgen drug. The medication is used to prevent infection and low white blood cell counts caused by chemotherapy.

Systematic (IUPAC) name
Human granulocyte colony stimulating factor
Clinical data
Trade namesNeupogen
Legal status
CAS number143011-72-7
ATC codeL03AA02
Chemical data
Molecular mass18802.8 g/mol

Filgrastim is a granulocyte colony-stimulating…

View original post 764 more words


New Drug Approvals

Visudyne, Verteporfin, Verteporfina, Verteporfine, Verteporfinum, Visudine, BPD verteporfin
Molecular Formula: C41H42N4O8
Molecular Weight: 718.79418 g/mol
Benzoporphyrin derivative monoacid ring A
18-ethenyl-4,4a-dihydro-3,4-bis(methoxycarbonyl)-4a,8,14,19-tetramethyl-23H,25H-benzo(b)porphine-9,13-dipropanoic acid monomethyl ester
US5798349; 5770619; 5756541; 5707608 (from FDA Orange Book)
For the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis syndrome. Verteporfin can also be used to destroy tumors.

Verteporfin (trade name Visudyne), a benzoporphyrin derivative, is a medication used as a photosensitizer for photodynamic therapy to eliminate the abnormal blood vessels in the eye associated with conditions such as the wet form of macular degeneration. Verteporfin accumulates in these abnormal blood vessels and, when stimulated by nonthermal red light with awavelength of 693 nm in the presence of oxygen, produces highly…

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ICH announces Q&A Document on Q11 Guideline – Main Focus: API Starting Materials

New Drug Approvals

The ICH has recently published a Business Plan and a Concept Paper on the elaboration of a Q&A document on the ICH Q11 Guideline. Read more here.—Main-Focus-API-Starting-Materials_9246,S-WKS_n.html

ICH announces Q&A Document on Q11 Guideline – Main Focus: API Starting Materials

The ICH Q11 Guideline entitled “Development and Manufacture of Drug Substances” from May 2012 has been implemented in the three ICH regions EU, USA and Japan for 2 years now. It describes the approach to developing APIs based on an in-depth understanding of the manufacturing process and adequate strategies to control this process. The document indicates what information should be provided about the quality of the API in Module 3 of the CTD (Common Technical Document) within the framework of a marketing authorisation application.

In the meantime, there has been an accumulation of cases where the applicant and the regulatory authorities adopted different positions with regard to…

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