Watson Laboratories Inc., a subsidiary of Watson Pharmaceuticals Inc. has filed Abbreviated New Drug Applications (ANDAs) with the US Food and Drug Administration (FDA) seeking approval to market Bimatoprost Ophthalmic Solution, 0.01 per cent and Bimatoprost Ophthalmic Solution, 0.03 per cent.

Watson's ANDA products are generic versions of Allergan, Inc.'s Lumigan 0.01 per cent and Latisse products, respectively. Lumigan 0.01 per cent is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Latisse is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness and darkness.

Allergan, Inc. filed suit against Watson in the United States District Court for the Eastern District of Texas on March 23, 2012 seeking to prevent Watson from commercializing its generic version of Lumigan 0.01 per cent prior to the expiration of certain US patents. Allergan, Inc. and Duke University filed suit against Watson in the United States District Court for the Middle District of North Carolina on March 30, 2012 seeking to prevent Watson from commercializing its generic version of Latisse prior to the expiration of certain US patents.

Each lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in separate stays of final FDA approval of Watson's ANDAs.  Each stay will be in effect for up to 30 months from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the litigation, subject to any other exclusivities.

For the twelve months ending January 31, 2012, Lumigan and Latisse had total US sales of approximately $409 million and $80 million, respectively, according to IMS Health data.


Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health.