Orexigen and its partner Takeda have taken Actavis to court to block a generic version of the firms’ diet pill Contrave.
The lawsuit alleges that the generic drugmaker Actavis has infringed patents on Orexigen and Takeda’s new weight-loss treatment Contrave (naltrexone and bupropion).
The treatment was approved in September last year after a three-year delay, caused by requests by the FDA for more data on cardiovascular safety.
In doing so it becomes the third weight-loss drug to be cleared by the FDA in recent years after a hiatus of more than a decade.
But despite being third to market among the new generation of obesity therapies after Eisai and Arena’s Belviq (lorcaserin) and Vivus’ Qsymia (phentermine/topiramate), both approved 18 months ago, Orexigen believes it will benefit from the market being developed by its competitors over the last year, which have yet to make significant sales gains despite the paucity of weight-loss therapies available on the market.
Contrave is indicated for use in tandem with a reduced-calorie diet and increased physical activity for chronic weight management in adults with a body mass index (BMI) of 30 or more, or 27 or more with an additional complication such as high blood pressure, diabetes or high cholesterol.
In March, an unauthorised release of early data from a Contrave study looking into risks of developing heart problems on taking the drug prompted the company to abandon the study.
The US is among the top five countries with the highest population of obese people, according to the World Health Organization, with more than 600 million people were obese worldwide as of 2014.
Actavis and Teva have both already filed for marketing approval of Qsymia’s copycat version.