Court Denies Hi-Tech Pharmacal’s Motion Regarding Dorzolamide and Timolol Ophthalmic Solution Exclusivity
Published: Dec 12, 2008
AMITYVILLE, N.Y.--(BUSINESS WIRE)--Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that the United States District Court denied Hi-Tech's motion for a preliminary injunction, permanent injunction, and declaratory judgment, and granted Apotex's motion for summary judgment, and entered summary judgment in favor of the FDA. Hi-Tech had challenged the FDA’s ruling that the Company had forfeited an exclusive generic marketing period for the Company’s Dorzolamide and Timolol ophthalmic solution ANDA. 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 launched Dorzolamide and Timolol on October 28, 2008 and continues to market the product.