Oxymorphone Battle Is a Matter for the FDA

     (CN) – Makers of the prescription painkiller Opana ER cannot pursue trademark claims over the marketing of generic oxymorphone, a federal judge ruled.
     Endo Pharmaceuticals, the result of DuPont Merck’s 1997 management buyout, has been approved by the Food and Drug Administration to sell Opana ER, short for extended release, since 2006.
     Activis, the former Watson Pharmaceuticals, sells a generic version of the opioid called Oxymorphone Hydrochloride Extended-Release Tablets CII.
     After the FDA rated the Actavis generic as AB, or actually bioequivalent, Opana ER, Endo developed a crush-resistant form of the drug in May 2012.
     It filed suit under the Lanham Act in 2012, claiming that the Actavis drug was not approved based on Opana ER’s New Drug Application and that the false marketing has harmed both Endo and the public.
     In its motion to dismiss, Activis argued that the FDA alone can determine differences between generic and brand-name versions.
     Endo countered that it had not asked the court to make any scientific finding or interfere with the FDA’s authority, but instead “to determine an existing fact – i.e., whether Actavis’s tablets are listed by FDA in the Orange Book as being AB rated to Opana ER.”
     U.S. District Judge Dennis Cavanaugh in Newark, N.J., found Tuesday that Endo’s claim about AB ratings cannot be adjudicated in a Lanham Act case between private parties.
     “The court agrees with Actavis and declines to make a determination whether Actavis’s generic is still AB equivalent to Opana ER or whether the new [crush-resistant] CRF formulation changes this designation,” the unpublished opinion states. “Notably, Endo agrees that FDA approved Actavis’s generic with an AB therapeutic equivalency rating to Opana ER. Endo does not contend that FDA revoked the AB rating. This court defers to the FDA to determine whether the new formulation of Opana ER is no longer AB equivalent to the generic Actavis product. The court also notes that an application has been made to the FDA on this issue, and it would be improper for the court to make a determination on this matter before the FDA has had an opportunity to do so. Thus Actavis’s motion to dismiss is granted without prejudice.”
     Endo reported just over $3 billion in revenue last year, while Actavis reported $5.91 billion.

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