all regulatory agencies seek to have an affordable health care for all patients (not to mention that generic alternatives are cheaper for the government).
The exact purpose of the 180 days exclusivity is to encourage generic companies to develop those generic drugs, to submit their ANDA earlier under the Paragraph IV claim, i.e., challenging the validity of an innovator’s patent, and by that, to bring an affordable drug product to the market sooner. In order to minimize the risk for the generic companies, as for sure the innovator will take them to court on the claim of infringing the patent/s in question, the benefit of being the ONLY generic alternative to the expensive innovator’s drug is a huge incentive. After being exclusively on the market for 6 months, it would be very difficult for other generic companies to take your market share, as you have already established presence, confidence and knowledge with the health care organizations. Being that you are the only generic, you have only the innovator as a competition from the pricing standpoint, so you have 6 months in which you can market your drug at a very high profit margin. Once new generics will come into the picture, prices drop dramatically.
You can read more about it here: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm079342.pdf
USFDA Is commited to get cheaper medicines to patients and increase competition among generic players. the 180 day exclusivity to generic company.companies who develops these generic drugs and submit their ANDA earlier under the Paragraph IV claim is to get players quicKly on the scene. is USFDA NOT SMART…………
DRUG REGULATORY AFFAIRS INTERNATIONAL 