Watson Pharmaceuticals confirmed that its subsidiary, Watson Laboratories, Inc. has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market brimonidine tartrate and timolol maleate ophthalmic solution, 0.2 per cent / 0.5 per cent.
Watson's brimonidine tartrate and timolol maleate ophthalmic solution, 0.2 per cent / 0.5 per cent is a generic version of 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 US District Court for the Eastern District of Texas seeking to prevent Watson from commercialising its product prior to the expiration of US 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 US sales of approximately $ 98 million according to IMS Health data.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialised branded pharmaceutical products focused on urology and women's health.