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MORRISTOWN, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to become the first to market a version of a popular opioid painkiller.
Watson said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s OxyContin (oxycodone) extended-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.
Purdue filed suit against Watson last week in the U.S. District Courts for the Southern District of New York, the District of Delaware and the Southern District of Florida, seeking to prevent Watson from marketing its version before the expiration of five patents scheduled to expire in 2017 and 2025, according to FDA records.
If Watson wins approval from the FDA, it will be entitled to 180 days in which to directly compete with Purdue’s version. OxyContin had sales of about $3.1 billion in 2010, according to IMS Health.
In other news, Watson said it received a “favorable” ruling from the U.S. Court of Appeals for the Federal Circuit in its efforts to market a generic version of Teva Women’s Health’s contraceptive Seasonique (levonorgestrel/ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]). The court reversed and remanded for trial a March 31 summary judgment order from the U.S. District Court for the District of Nevada regarding Watson’s challenge to U.S. Patent No. 7.320,969; Watson had filed an approval application with the FDA for a version of the drug containing a Paragraph IV certification, a legal assertion that the ‘969 patent, which is scheduled to expire in January 2024, was invalid, unenforceable or not infringed.