Watson Pharmaceuticals confirmed (in a press release Here ) that its subsidiary, Watson Laboratories filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Ramelteon (Rozerem) 8 mg Tablets.
Innovator has listed following patent in the Orange Book for this product:
US6034239 (Expiry: Mar 6, 2017): The patent covers Ramelteon as product
Subsequently, in an attempt to block generic version of Ramelteon (Rozerem) 8 mg Tablets, innovator Takeda has filed an infringement action (based on '239 Patent) against generic player Watson in U.S. District Court for the District of Delaware. Earlier, innovator has sued generic player Teva for filing ANDA with Para IV certification.
As per press release, Watson believes it may be a "first applicant" to file an ANDA for Ramelteon (Rozerem) 8 mg Tablets, accordingly, may be entitled to 180 days of shared generic market exclusivity.
Earlier, innovator got approval to market Ramelteon (Rozerem) 8 mg Tablets on Jul 22, 2005. For the twelve months ending September 30, 2009 Ramelteon (Rozerem) 8 mg Tablets had total U.S. sales of approximately $91 million according to IMS Health data.
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