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U.S. Court of Appeals for the Federal Circuit Rules in Favor of Merck in Sitagliptin Dihydrogen Phosphate Patent Lawsuit
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Rhea-AI Summary
Merck (NYSE: MRK) received a favorable ruling from the U.S. Court of Appeals for the Federal Circuit regarding a patent challenge on sitagliptin, a key ingredient in JANUVIA, JANUMET, and JANUMET XR. This ruling affirms the validity of U.S. Patent No. 7,326,708, ensuring patent protection until May 2027, including pediatric exclusivity. The company has settled with multiple generics, allowing market entry for sitagliptin products in May 2026 and extended-release versions by July 2026.
Positive
U.S. Court of Appeals affirmed patent validity for sitagliptin, protecting JANUVIA and JANUMET until May 2027.
Settlement with generics allows for limited market entry in May 2026 and July 2026.
Negative
None.
Sitagliptin is an active ingredient in JANUVIA®, JANUMET® and JANUMET® XR
RAHWAY, N.J.--(BUSINESS WIRE)--
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Court of Appeals for the Federal Circuit ruled in favor of the company in a patent challenge brought by Mylan Pharmaceuticals, Inc. (now Viatris) related to sitagliptin dihydrogen phosphate, an active ingredient in JANUVIA® (sitagliptin), JANUMET® (sitagliptin and metformin hydrochloride) and JANUMET® XR (sitagliptin and metformin hydrochloride extended-release).
Viatris had challenged validity of U.S. Patent No.7,326,708 in an inter partes review before the U.S. Patent Office. On May 7, 2021, the Patent Office issued a decision in Merck’s favor, finding all challenged claims valid. Viatris appealed that decision to the Court of Appeals for the Federal Circuit, which today affirmed the decision.
Viatris had previously challenged validity of the patent in a case filed in the U.S. District Court for the Northern District of West Virginia. The District Court ruled in favor of Merck in a decision dated Sept. 21, 2022.
Today’s ruling from the U.S. Court of Appeals provides JANUVIA, JANUMET and JANUMET XR patent protection through May 2027, which includes six (6) months of pediatric exclusivity. The company has settled with multiple generic companies, providing that these generic companies can bring their sitagliptin dihydrogen phosphate or sitagliptin-metformin product to the market in May 2026 or earlier under certain circumstances, and their sitagliptin-metformin extended-release product to the market in July 2026 or earlier under certain circumstances.
About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2021 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
