Teva Sues FDA for Changing ANDA Exclusivity Requirements

In the latest legal twist over generics of Allergan’s blockbuster dry eye treatment, Restasis, Teva is suing the FDA for changing its policy on eligibility for 180-day marketing exclusivity for generics.

Under Paragraph IV of the Drug Price Competition and Patent Term Restoration Act of 1984 — also known as the Hatch-Waxman Amendments — a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug, by filing a Paragraph IV "certification" that the patent for the branded drug is invalid, unenforceable, or will not be infringed by the generic product.

But in July, the FDA issued a decision letter relating to Suboxone generics, ruling that ANDA applicants can qualify for 180-day exclusivity whether or not they provide a certification under Paragraph IV.