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news.Orexigen Therapeutics has received a notice of allowance from the U.S. Patent and Trademark Office (PTO) for U.S. Patent Application No. 11/757,773, which covers use of Orexigen's sustained release formulation of naltrexone, which was designed to improve drug tolerability for Contrave (naltrexone HCl / bupropion HCl extended release), in a method for treating obesity.
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The patent is expected to expire in March of 2028. Orexigen expects the patent to be listed in the Orange Book maintained by the United States Food and Drug Administration.
"A key component of Orexigen’s strategy is to strengthen and extend intellectual property protection for Contrave," said Michael Narachi, CEO of Orexigen. "We are pleased that patent protection for use of this naltrexone formulation – and for Contrave – is now expected to extend at least to 2028."
Contrave is currently protected by U.S. patent number 7,375,111 and U.S. patent number 7,462,626, which Orexigen refers to collectively as the Weber/Cowley patents and which are expected to expire in 2025/2024.
The Weber/Cowley patents cover the current composition of Contrave and methods of administering it to treat obesity. Orexigen and/or licensors have filed a number of international counterparts to the Weber/Cowley patents in foreign countries.
A European counterpart application to the Weber/Cowley patent has issued in the European Patent Office, or EPO, and provides protection for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in the various EPO countries in which the patent has been registered. Orexigen has also filed patent applications, directed to various treatment and formulation aspects of Contrave, in the United States and certain foreign countries under the Patent Cooperation Treaty, or PCT.
Use of Contrave for the treatment of insulin resistance is protected by U.S. patent number 8,815,889, which is expected to expire in 2024. A proprietary tri-layer Contrave tablet and its use for weight loss are protected in the United States by U.S. patent numbers 8,088,786 and 8,318,788, which are expected to expire in February 2029 and November 2027, respectively.
In addition, the dose escalation schedule of Contrave is protected by U.S. patent 8,722,085, which is expected to expire in November 2027. Orexigen has filed other patent applications in the United States and other parts of the world with the potential, if the patents issue, to extend intellectual property protection to 2034.