Actavis Plc: Orexigen Therapeutics, Inc. And Takeda Pharmaceutical Filed Lawsuit To Block Generic Weight-Loss Pill

Orexigen Therapeutics, Inc. (NASDAQ:OREX) and its partner Takeda Pharmaceutical Co Ltd (ADR) (OTCMKTS:TKPYY) have filed a lawsuit against Actavis Plc (NYSE:ACT) to block a generic version of a weight-loss pill sold in the market under the name Contrave, according to Reuters.

The lawsuit against Actavis Laboratories FL Inc, Andrx Corp, Actavis Pharma Inc, and Actavis Inc was filed at the US District Court of the District of Delaware. According to the suit, Actavis infringed patent rights on Orexigen and Takeda’s diet-pill, Contrave.

The lawsuit came as a result of Actavis submitting an Abbreviated New Drug Application (ANDA) in an attempt to launch a generic version of Orexigen and Takeda’s Contrave, much before the US patents on the drug expire, as per the dates mentioned in the US Food and Drug Administration’s (FDA) Approved Drug Products. Orexigen and Takeda hold the stance that Actavis, by filing for FDA approval of the generic version and by planning to launch it soon, is actually acting against the patent rights of the weight-loss treatment, which are solely held by Orexigen and Takeda.

Contrave is one of the three weight-loss products that are expected to take up a significant share of the fast-expanding obesity drug market. The other two major pills, forecasted to offer strong competition to Orexigen and Takeda’s diet-pill, are Belviq, by Arena Pharmaceuticals, Inc. (NASDAQ:ARNA), and Qsymia, by VIVUS, Inc. (NASDAQ:VVUS); both these drugs recently won approvals from the FDA.

The obesity drug market presents a high revenue-generating opportunity for any company that sets foot in the arena. The US, ranking among the top five countries of the world with the largest obese population, has approximately 34.9%, or 78.6 million, of the adult population who is considered obese, as per data gathered by the US Centers for Disease Control and Prevention. Obesity has also been contributing to ever-rising healthcare costs in the US; the total medical expenditure on obesity products alone stood at $147 billion for the year 2008. Obesity is also a widespread disease worldwide; as many as 600 million people were reported to be affected by the condition globally in 2014, according to the World Health Organization.

Takeda jointly developed the drug with Orexigen and is entrusted with the responsibility to sell the drug inside the US. Both Takeda and Orexigen look determined to protect their market share against the threat of any potential generic competition.

However, Contrave has been facing its own share of difficulties since March this year, when a particular study evaluating the heart risks posed by the weight-loss pill revealed some serious issues related to the drug, forcing Orexigen to halt the said study. Takeda retailed by filing a formal dispute against Orexigen in May, asking the company to cover all the expenses for the new heart risk trial, which is due to start soon.

As per the terms of the Hatch-Waxman Act, because Orexigen and Takeda have filed a lawsuit against Actavis within 45 days of the Paragraph IV certification notice, the FDA’s decision to approve the ANDA submitted by Actavis will be delayed by at least a period of thirty months from “Takeda’s receipt of the notice,” or until the District Court decides that the patents on the said drug are invalid, whichever is shorter.

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