Commission backs purchasers and end payers in appeal of district court dismissal of suits against Forest and six generic manufacturers. It contends the court contravened Supreme Court’s Actavis decision and proffered its own justifications for side deals in patent settlements.
The US Federal Trade Commission contends that a district court got it wrong in finding that Forest Laboratories, Inc.’s side deals with generic manufacturers did not constitute unjustifiable payments to delay entry of generic versions of its high blood pressure drug Bystolic (nebivolol).
The commission filed a 20 June amicus brief urging the US Court of Appeals for the Second Circuit to...
Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.
The US healthcare system saved billions by allowing early market entry for generic and biosimilar medicines through patent settlements. However, long-winded litigations with an expensive price tag and the Senate’s reintroduced pay-for-delay bill are set to make the situation even more dire.
A class action suit alleging AstraZeneca delayed generic competition for Seroquel XR by making illegal agreements that stifled market entry for generic quetiapine competitors has been dismissed after the originator agreed to settle for tens of millions of dollars.
In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.
