Takeda, Orexigen Sue Actavis Over Anti-Obesity Drug

Orexigen Therapeutics and Takeda filed a patent infringement suit in federal court aimed at blocking Actavis from marketing a generic version of their anti-obesity drug Contrave.

The brandmakers claim that Actavis infringed upon seven patents for Contrave (extended-release naltrexone HCl and bupropion HCl), the last of which is set to expire in February 2030.

Contrave was approved by the FDA last year for adults with a body mass index over 27 who have high blood pressure, high cholesterol or Type 2 diabetes.

Orexigen and Takeda acknowledge that Actavis filed a notice letter on April 20 that included an offer of confidential access to its ANDA. However, the OCA was rejected and efforts to negotiate a revised one failed, the brandmakers say, adding that they have yet to receive any information regarding the ANDA.

Since the notice letter doesn’t deny infringement, Actavis acknowledges that its product infringes Contrave’s patents, the companies say. By filing the lawsuit, Takeda Pharmaceuticals and Orexigen Therapeutics v. Actavis, FDA approval of the ANDA will be stayed by 30 months or until the court finds the patents invalid, unenforceable or not infringed, the brandmakers say.

Actavis faces a similar lawsuit from Vivus over its efforts to market a different anti-obesity drug. The brandmaker sued Actavis in June 2014 in response to the generics maker’s Paragraph IV challenge to Vivus’ Qsymia (phentermine and topiramate extended-release). Actavis’ intention to market a generic Qsymia came to light in a May 2014 SEC filing.

Orexigen CEO Mike Narachi said that the brandmakers plan to vigorously enforce Contrave’s patents.

Actavis did not respond to a request for comment by press time. — John Bechtel