Hatch-Waxman Amendments

There have been changes to the US Hatch-Waxman law covering drug competition.

While changes to the law are quite complicated, they actually simplify the relationship between multiple ANDA filings and reduce the change that a generic will launch a product at risk of a reversal on appeal.Essentially, the new amendments set up a very orderly timeline which much be followed by brands and generics alike. An ANDA application filed before a brand submits patent information to the FDA cannot be subject to a 30-month stay and patents listed after an ANDA filing cannot be the basis of a stay, even when timely filed.

Litigation can be brought by either the ANDA application of the NDA holder/patentee even in situations where no stay is appropriate. An ANDA applicant is now required to file an application that is approvable within 30 months; otherwise exclusivity can be forfeited. Exclusivity may also be lost for failure to enter into certain agreements, withdrawal of the ANDA and failure to market (with the exception that exclusivity is not lost following a decision favorable to the ANDA holder by the FDA).

The 505(b)(2) Approval Process -- A Useful Regulatory Pathway?

The FDA permits approval of drugs and certain biologics via the 505(b)(2) approval process. The 505(b)(2) route approval of approval differs from the traditional ANDA process in that:

• the 505(b)(2) applicant can avoid most of the costly and time-consuming clinical trials;

• the 505(b)(2) applicant may qualify for three or five years of marketing exclusivity, as appropriate. In addition an approved 505(b)(2) product, like an approved ANDA product, may receive an AB substitutability rating in the FDA's Orange Book, making it readily available for substitution by pharmacists. Has this become a new pathway for generics to circumvent the traditional NDA approval process?

Hatch-Waxman Act

The Hatch-Waxman Act is a federal law enacted in 1984. It contains provisions to both foster competition and increase patent strength. The Hatch-Waxman Act provides incentives to support the development of generic versions of off-patent drugs and permit patent owners to recover time lost during FDA approval.