Known as the Hatch–Waxman Act, the changes had two main aspects 1. The first was restoration of a period of patent protection for new drugs to compensate for the time taken for their clinical ...

Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version ...

That Edge is Ours to Lose with the Inflation Reduction Act. Last year, America celebrated the 40th anniversary of the Hatch Waxman Act, which established the legal framework that has led to the ...

Under provisions in the Hatch-Waxman Act, the FDA permits marketing of generics for older indications that no longer have patent protection, even if the brand-name drug develops new, patented uses.

thus providing the company with additional protection under the Hatch-Waxman Act. This comes on top of the market exclusivity granted by Orphan Drug Designation in both the U.S. and Europe.

This will provide Quince notice of future generic applicants and give the company other stay provisions under applicable provisions of the Hatch-Waxman Act. This protection is in addition to the ...