Orexigen and Takeda filed their lawsuit in the US District Court of Delaware in response to the filing of an abbreviated new drug application (ANDA) by Actavis for generic naltrexone/bupropion. The move automatically prevents FDA approval of the ANDA from Actavis for 30 months, unless a district court declares the patents on Contrave invalid, unenforceable or not infringed.

Contrave was only approved by the US Food and Drug Administration (FDA) in September 2014 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m² or greater (obese) or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition, e.g. hypertension, type 2 diabetes mellitus or dyslipidemia.

The obesity rate in 2010 was approximately 36% of the US population of adults over 20 years of age, according to the Centers for Disease Control and Prevention (CDC) in the US. This is predicted to reach 43% by 2018 and to exceed 50% by 2030.

The patent on Orexigen’s sustained release formulation is only expected to expire in 2028.

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