AMITYVILLE, N.Y.--(BUSINESS WIRE)--Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that the Company filed a complaint in the U.S. District Court for the District of Columbia against the U.S. Food and Drug Administration (FDA) requesting a declaratory judgment related to Hi-Tech’s Abbreviated New Drug Application (ANDA) for dorzolamide and timolol ophthalmic solution, the generic for Merck’s Cosopt®. Hi-Tech seeks confirmation that it is entitled to a 180-day period of market exclusivity as the first applicant to submit an ANDA to the FDA containing a paragraph IV certification challenging the validity of the brand company’s patents. Hi-Tech’s complaint also seeks issuance of an injunction preventing the FDA from granting final marketing approval to any other ANDA for 180 days after Hi-Tech commences commercial marketing.
