and Exclusivities for Patent Holders and ANDA Applicants(Drug Price Competition and Patent Term Restoration Act- 1984)
(Hatch – Waxman Act: Balancing incentives to innovators & ensuring the availability of low cost generics)
KEY FEATURES OF HWA
Hatch – Waxman act changed certain
aspects of the new drug application process
and new drugs patent term. The brand-
name companies (innovator) can apply for up
to five additional years longer patent
protection for the new medicines they
developed to make up for time lost while
their products were going through FDA's
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