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PARSIPPANY, N.J. — Actavis hopes to become the first to market a generic drug for treating chronic pain, the company said Monday.
Actavis said it had filed with the Food and Drug Administration for approval of tapentadol extended-release tablets in the 50-mg, 100-mg, 150-mg and 200-mg strengths. The drug is a generic version of Johnson & Johnson subsidiary Janssen Pharmaceuticals' Nucynta ER. The drug is used as a continuous, around-the-clock analgesic over a long period of time.
Actavis' regulatory application included a Paragraph IV certification, a legal assertion that Nucynta ER's patent protection in invalid, unenforceable or not in danger of infringement. Such patent challenges are used by drug companies looking to be first to market.
In response to the challenge, J&J and Grunenthal GMBH filed suit against Actavis last week in the U.S. District Court for the District of New Jersey. The lawsuit places an automatic 30-month stay of FDA approval on Actavis' product, or until the companies reach a settlement.
Nucynta ER had sales of about $86 million during the 12-month period that ended in May, according to IMS Health.
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