Orexo and Actavis Fighting Over Zubsolv

July 8, 2014

Swedish brand manufacturer Orexo AB is suing generic firm Actavis over its bid to market a version of Orexo’s opioid treatment drug Zubsolv.

Orexo claims in a June 26 lawsuit that Actavis’s May 16 paragraph IV ANDA seeks to infringe on three of Zubsolv’s patents, the ’996, the ’361 and the ’198. Actavis says it believes it may be the first to file its ANDA, and is entitled to 180-days of exclusivity on Zubsolv (buprenorphine and naloxone), a combination therapy delivered by tablet under the tongue. 

The Swedish company has promised to defend its intellectual property. “The Zubsolv products have a significant market potential and the ANDA filing of generic versions could be expected,” President and CEO Nikolaj Sørensen said.

Zubsolv’s last patent on the drug, the ’198 patent, extends until 2029. The first patent is set to expire in 2019, according to the Orange Book. Orexo reported global sales worth nearly $5 million from Zubsolv in the first quarter of 2014. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.