Drug maker Cephalon has settled its patent lawsuit with Barr Pharmaceuticals Inc., agreeing to give Barr a license to sell a generic version of Cephalon’s potent painkiller Fentora in 2018, according to the Securities and Exchange Commission. Barr will receive a non-exclusive, royalty-free right to sell the drug one year before Cephalon’s patent expires. However, if another generic version of Fentora hits the U.S. market before Barr can launch its brand, Barr can introduce its version even earlier than 2018.
Fentora is a new opioid drug approved for the treatment of breakthrough pain in cancer patients who are being treated around the clock with opioids. While its FDA-approved usage is limited, the drug has a surprisingly high off-label use for the treatment of headaches, backaches and injuries. The FDA discourages this unapproved use as the agency has received numerous reports of serious injuries and deaths in patients prescribed Fentora without having first developed a tolerance to opioid treatment.
Cepahlon’s arrangement with Barr does not affect the drug maker’s patent lawsuit filed against Watson Pharmaceuticals Inc., which seeks to prevent Watson from commercializing armodafinil prior to the expiration of the patent of Cephalon’s brand-name version of armodafinil, Nuvigil. Armodafinil is indicated for the improvement of wakefulness in adults who experience excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder, or narcolepsy.
Source: Watson Pharmaceuticals