Par Health Launches First and Only Generic Version of Janumet® XR (sitagliptin and metformin HCl extended-release) Tablets in the United States
PR Newswire
ST. LOUIS, July 24, 2026
First-to-Market Generic Entry Underscores Par Health's Commitment to Expanding Access to High-Quality, Affordable Medicines
ST. LOUIS, July 24, 2026 /PRNewswire/ -- Par Health, Inc. ("Par Health" or the "Company"), a global pharmaceutical company and manufacturer of essential medicines, today announced the launch of its generic version of Merck's Janumet® XR (sitagliptin and metformin HCl extended-release) tablets for oral use, following final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application.
Par Health's sitagliptin metformin XR is the first and currently the only FDA-approved generic of Janumet® XR available in the U.S. According to IQVIA data, Janumet® XR had estimated annual U.S. sales of approximately $269.9 million for the 12 months ended May 2026.
"We are proud to introduce this first-to-market generic, helping expand access to more affordable treatment options for patients," said Jake Longenecker, Executive Vice President and Chief Commercial Officer, Generics. "This milestone strengthens our generics portfolio and reflects our continued focus on delivering quality, low-cost medicines for patients and healthcare providers."
Click for Full Prescribing Information including Boxed Warning.
Janumet® XR is a registered trademark of Merck Sharp & Dohme LLC.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements regarding the Company's business priorities, strategic objectives, product development and commercialization, expected market position, and growth. These statements are based on current expectations, assumptions, and projections of management and are subject to significant risks and uncertainties. Actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors, many of which are outside the Company's control. These factors include, but are not limited to: the Company's ability to successfully commercialize its products, including its generic version of Janumet® XR; competition within the pharmaceutical industry; the timing and impact of regulatory actions and approvals by the U.S. Food and Drug Administration and other authorities; the Company's ability to maintain compliance with applicable regulatory requirements at its manufacturing facilities; the Company's ability to sustain sales and profits on products over time; reliance on third-party manufacturers, suppliers, and service providers; supply chain disruptions; market acceptance, pricing pressures, and reimbursement dynamics; and general economic, industry, and market conditions. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or otherwise, except as required by applicable law.
About Par Health
Par Health is a pharmaceutical company focused on Elevating the Essentials™. We develop, manufacture, and deliver high-quality generic medicines, active pharmaceutical ingredients (APIs) and sterile injectable products across a broad range of therapeutic areas, dosage forms and delivery technologies. With a vertically integrated, U.S.-advantaged manufacturing network and global workforce, we are committed to reliability, integrity and operational excellence – because we believe great healthcare is built on getting the essentials right. To learn more, please visit parhealth.com and connect with us on LinkedIn.
Contacts
Investors
Stacie Phillips, Corporate Controller and Head of Investor Relations
IR@parhealth.com
Media
Gena Holthaus, Senior Director, Corporate Brand and Communications
Communications@parhealth.com
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SOURCE Par Health