Court denies Hi-Tech Pharmacal

The US District Court has denied Hi-Tech Pharmacal's motion for a preliminary and permanent injunction, and declaratory judgment, granting Canadian generics firm Apotex' motion for summary judgment, and entered summary judgment in favor of the Food and Drug Administration.

Hi-Tech had challenged the FDA's ruling that the company had forfeited an exclusive generic marketing period for its dorzolamide and timolol ophthalmic solution Abbreviated New Drug Application. The product is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta blockers. Hi-Tech notes that it launched dorzolamide and timolol on October 28 and continues to market the product.