Hi-Tech Pharmacal Receives Tentative Approval for Dorzolamide Hydrochloride with Timolol Maleate Ophthalmic Solution

Apr 10, 2008 - Hi-Tech Pharmacal Co., Inc. announced today that the US Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for dorzolamide hydrochloride with timolol maleate ophthalmic solution. Hi-Tech's dorzolamide hydrochloride with timolol maleate ophthalmic solution is the generic equivalent of Merck's Cosopt(R) and is indicated for the treatment of glaucoma. According to IMS, Merck's Cosopt(R) had sales of $334 million in 2007. The Company believes that it has 180 days of marketing exclusivity for generic dorzolamide hydrochloride with timolol maleate ophthalmic solution, and will begin marketing the product upon the completion of Merck's pediatric exclusivity period in October 2008. The Company has a partner for the product who will share in the profits.