ST. LOUIS – July 24, 2026
Par Health, Inc. has announced the U.S. launch of its generic version of Janumet® XR (sitagliptin and metformin hydrochloride extended-release) tablets, following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA). The newly launched product is the first and currently the only FDA-approved generic equivalent of Janumet® XR available in the United States, marking a significant milestone in the diabetes treatment market. According to IQVIA data, branded Janumet® XR generated approximately $269.9 million in U.S. annual sales during the 12 months ending May 2026, highlighting the commercial opportunity for the newly approved generic. The launch reinforces Par Health’s strategy of expanding access to high-quality, affordable medicines while strengthening its growing portfolio of generic pharmaceutical products.
FDA Approval Expands Access to Affordable Diabetes Treatment
The FDA approval enables Par Health to become the first-to-market supplier of a generic version of Janumet® XR, a widely prescribed oral medication used to improve blood sugar control in adults with type 2 diabetes mellitus. By introducing a lower-cost alternative to the branded therapy, the company aims to improve patient access while helping reduce healthcare costs for providers and payers. Jake Longenecker, Executive Vice President and Chief Commercial Officer of Generics, stated that the launch reflects the company’s commitment to delivering quality, affordable medicines and further strengthens its expanding generics portfolio. As the only FDA-approved generic currently available, the product provides healthcare professionals and patients with an important new treatment option in the competitive diabetes care market.
Generic Portfolio Continues to Drive Growth Strategy
The introduction of generic Janumet® XR aligns with Par Health’s broader strategy of developing and commercializing essential generic medicines across multiple therapeutic areas. The company continues to focus on expanding patient access by introducing high-value generic alternatives following regulatory approval. With vertical integration, U.S.-based manufacturing capabilities, and expertise in active pharmaceutical ingredients (APIs) and sterile injectable products, Par Health is positioned to support reliable product supply while maintaining regulatory compliance and manufacturing quality. The successful commercialization of the first generic Janumet® XR further enhances the company’s position in the U.S. generic pharmaceutical market and demonstrates its ability to capitalize on important product launch opportunities.
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Par Health Strengthens Presence in the U.S. Generics Market
Par Health develops, manufactures, and supplies generic medicines, APIs, and sterile injectable therapies across a broad range of therapeutic categories through its integrated manufacturing network. The company’s latest product launch reflects its long-term commitment to improving access to affordable medications while maintaining high standards of manufacturing excellence and product reliability. Although the company noted that commercialization remains subject to market dynamics, competition, pricing pressures, reimbursement conditions, and supply chain factors, the successful FDA approval and first-to-market launch position Par Health to capture significant market share in the U.S. diabetes therapeutics segment. The milestone also reinforces the company’s mission of delivering essential medicines that support healthcare providers and improve patient outcomes nationwide.
Source: Par Health press release
