PARA IV FILING & 180 DAY’s MARKETTING EXCLUSIVITY FOR FIRST SUCCESSFUL ANDA FILER
(PARA IV ANDA FILING = CHALLENGING WEAK PATENT)
The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman act) of 1984 streamlined generic drug approval process in US. HWA created an abbreviated process for generic drug approval without conducting costly and duplicative clinical trials. (Under the new legislation, generic entrants needs to establish the bio equivalence of its drugs to the original).The rules created processes and incentives for both branded and generic companies involving challenges to patents.
Para I: A Para I filing for the launch of generic drug is made when the innovator has not made the required information in the Orange book.
Para II: A Para II filing is made when the drug is already off patent.
Para III: A Para III filing is made when the applicant does not have any plans to sell the generic drug until the original drug is off patent.
PARA – IV Filing & 180 days exclusivity