Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5%.
Watson’s Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5% is a generic version of Allergan Inc.’s Combigan product. Combigan is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP
Allergan, Inc. filed suit against Watson on September 2, 2010 in the United States District Court for the Eastern District of Texas seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent Nos. 7,030,149; 7,320,976; 7,323,463 and 7,642,258. Allergan’s suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson’s ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities
For the twelve months ending July 31, 2010, Combigan had total U.S. sales of approximately $98 million according to IMS Health data.