US generic drugs firm Watson Pharmaceuticals (NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories, filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5%, a generic version of Allergan's (NYSE: AGN) Combigan product.
Combigan, which generated sales of $90 million in the 12 months ended July, according to IMS Health data, 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.
According to Watson, Allergan filed suit against Watson on September 2 in the US District Court for the Eastern District of Texas seeking to prevent Watson from commercializing 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.
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