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news.Teva Women's Health has filed a lawsuit against Watson Laboratories, a subsidiary of global specialty pharmaceutical company Watson Pharmaceuticals, in connection with the filing of Watson's abbreviated new drug application (ANDA) for synthetic conjugated estrogens, A, in the 0.3mg, 0.45mg, 0.625mg, 0.9mg and 1.25mg tablet strengths.
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Watson’s ANDA is for the generic equivalent of Teva’s Cenestin. The suit was filed on April 23, 2010, in the US District Court for the District of New Jersey.
Cenestin (synthetic conjugated estrogens, A) tablets are for use by women after menopause to reduce hot flashes and treat dryness, itching, and burning in and around the vagina.
Pursuant to the Hatch-Waxman Act, Watson previously notified Teva Women’s Health that Watson’s ANDA contains a paragraph IV certification asserting that US Patent No 5,908,638 is invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the drug products described in Watson’s ANDA.