Par Health Launches First and Only Generic Version of Janumet® XR in the United States
核心洞察
Par Health (搜索) received final FDA approval and launched the first generic version of Merck's Janumet® XR (sitagliptin and metformin HCl extended-release) tablets in the U.S.
Janumet® XR had estimated annual U.S. sales of approximately $269.9 million for the 12 months ended May 2026, according to IQVIA data.
The first-to-market generic entry aims to expand patient access to more affordable treatment options for type 2 diabetes (搜索).
Par Health (搜索), Inc. announced on July 24, 2026, the U.S. 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 (ANDA). This marks the first — and currently only — FDA-approved generic of Janumet® XR available in the United States.
"This milestone strengthens our generics portfolio and reflects our continued focus on delivering quality, low-cost medicines for patients and healthcare providers," said Jake Longenecker, Executive Vice President and Chief Commercial Officer, Generics at Par Health (搜索).
Market Significance
According to IQVIA data cited in the announcement, Janumet® XR had estimated annual U.S. sales of approximately $269.9 million for the 12 months ended May 2026. The introduction of generic competition into this market is expected to provide a more affordable alternative for patients requiring combination therapy with a DPP-4 inhibitor and metformin in an extended-release formulation.
"We are proud to introduce this first-to-market generic, helping expand access to more affordable treatment options for patients," Longenecker added.
Regulatory and Product Details
The FDA approval came through the ANDA pathway, which allows generic manufacturers to demonstrate bioequivalence to the reference listed drug without repeating full clinical trials. The product carries a Boxed Warning, consistent with the metformin component's known risk of lactic acidosis, and full prescribing information is available.
Janumet® XR is a registered trademark of Merck Sharp & Dohme LLC. Par Health (搜索)'s generic version combines sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, with metformin hydrochloride in an extended-release formulation designed for once-daily oral administration.
About Par Health (搜索)
Par Health (搜索) is a global pharmaceutical company focused on developing, manufacturing, and delivering generic medicines, active pharmaceutical ingredients (APIs), and sterile injectable products across a broad range of therapeutic areas and dosage forms. The company operates a vertically integrated, U.S.-advantaged manufacturing network and maintains a global workforce committed to reliability and operational excellence.