Watson and Endo reach Opana ER deal

Watson Pharmaceuticals has reached a settlement with Endo Pharmaceuticals that will allow Watson to launch its generic version of Endo's pain drug Opana ER (oxymorphone ER) on September 15, 2012 – before the patent protection on the branded drug expires.

Watson filed an Abbreviated New Drug Application with the US Food and Drug Administration (FDA) in March of this year, seeking approval to market a generic version of Opana ER in a number of dosage strengths to treat moderate to severe pain in patients who need continuous treatment over an extended period of time. The marketing application included a paragraph IV certification claiming that the Opana patents are invalid or unenforceable.

Shortly afterwards, Endo filed suit against the company in an effort to block the unbranded product. The settlement of that suit grants Watson a royalty-free licence to the US patents covering the drug and the right to launch its product on September 15, 2012, or possibly earlier under certain circumstances that were not disclosed.

Under similar settlement agreements that were previously announced, the generics firm Sandoz may also enter the US market with its version of the drug on September 15, 2012, and Impax may begin selling generic Opana ER on January 1, 2013.

Meanwhile, Endo filed a marketing application with the FDA in September seeking approval of a new formulation of the product that is designed to be crush-resistant to prevent abuse. The application was granted a priority review, and the FDA will aim to act on it by January 7, 2011.

Combined sales of injectable Opana and Opana ER were $230.6m in 2009 and are expected to increase this year.