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news.Watson Pharmaceuticals has confirmed that Pfizer and Wyeth Pharmaceuticals have sued its subsidiary Watson Laboratories, Florida, in connection with the filing of Watson's abbreviated new drug application (ANDA) for Rapamune (sirolimus) tablets in 1mg and 2mg strengths.
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Watson’s ANDA is for a generic equivalent of Wyeth’s Rapamune tablets product. The suit was filed on 28 April, 2010 in the US District Court for the District of Delaware.
Rapamune tablets are indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants.
Pursuant to the Hatch-Waxman Act, Watson Pharmaceuticals has previously notified Pfizer and Wyeth that Watson’s ANDA contains a paragraph IV certification asserting that US patent no: 5,100,899 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.
Based on available information, Watson Pharmaceuticals said that it may be a first applicant to file an ANDA for the 1mg and 2mg generic version of Rapamune and should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for those strengths.