Companies jointly advance development and planned U.S. commercialisation of generic tirzepatide injection, subject to FDA approval
BRIDGEWATER, N.J., July 8, 2026 – Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) and Adalvo announced that the U.S. Food and Drug Administration (FDA) has accepted for review two Abbreviated New Drug Applications (ANDAs) filed at NCE-1 for generic tirzepatide injection in the United States.
The two ANDAs, referencing Mounjaro® (autoinjector) and Zepbound® (autoinjector), seek approval for single-dose prefilled pen presentations of the respective reference products for all currently approved indications, including the treatment of type 2 diabetes and chronic weight management, including for adults with obesity and adults with moderate to severe obstructive sleep apnea (OSA). This acceptance marks an important milestone in the companies' joint efforts to advance complex injectable medicines and metabolic therapies.
Tirzepatide was the first approved dual GIP and GLP-1 receptor agonist therapy to reach the market and remains the only such therapy indicated for the treatment of both type 2 diabetes and chronic weight management.
According to IQVIA, U.S. tirzepatide sales increased from almost $41 billion in 2025 to $72.8 billion in 2026.
Amneal and Adalvo are jointly developing these generic tirzepatide autoinjector products in the United States, subject to FDA approval, and Amneal will lead all commercialisation efforts. The partnership combines Adalvo's expertise in complex product development and global supply chain with Amneal's regulatory and commercial expertise, including its established U.S. commercialisation infrastructure.
Adalvo's Chief Commercial Officer, Arni Baldursson, commented: "I'm incredibly proud of the Adalvo team for this submission. Tirzepatide is exactly the kind of complex injectable programme that depends on close cross-functional and cross-company collaboration. This milestone reflects Adalvo's long-term focus on building an advanced platform for complex injectable medicines, and our shared commitment with Amneal to get critical metabolic therapies into the hands of patients who need them."
"As America's leading Affordable Medicines provider, we take our role in expanding patient access to key therapies very seriously," said Gregory Sgammato, Amneal's Chief Corporate Development Officer. "And as the GLP-1 market evolves, it is critical that patient affordability and flexibility remain top of mind for healthcare companies across the country. This FDA submission and acceptance is an important first step in achieving that goal, and if approved, these products will expand Amneal's leading portfolio of complex injectables, including GLP-1 and drug-device combinations. Amneal and Adalvo are extremely proud of our respective development and regulatory experts who made this submission possible."
The companies' work on these applications reflects a shared commitment to advancing complex generic medicines and expanding future treatment options for patients through high-quality development, regulatory execution and commercialisation.
Mounjaro® and Zepbound® are registered trademarks of Eli Lilly and Company.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, New Jersey, is a diversified, global biopharmaceutical leader focused on expanding access to affordable and innovative medicines. Founded in 2002 by brothers and co-CEOs Chirag and Chintu Patel, Amneal was built on the belief that innovation only matters if it’s accessible. Today, Amneal has a diverse and growing portfolio of approximately 300 complex, specialty and biosimilar medicines, delivering over 160 million prescriptions each year, primarily in the United States. Our Affordable Medicines segment spans retail, injectable, and biosimilar products. Our Specialty segment provides branded treatments in neurology, including Parkinson’s disease and migraine, and endocrinology. Our AvKARE segment distributes pharmaceuticals and medical products to U.S. federal, retail, and institutional customers. For more information, visit www.amneal.com and follow us on LinkedIn.
About Adalvo
Adalvo is a leading global B2B pharmaceutical company with a differentiated portfolio spanning specialty generics, peptides, biosimilars and brands. Its end-to-end platform covers portfolio selection, development, regulatory, supply and commercial out-licensing, enabling partners to accelerate product launches while ensuring reliable long-term supply. Leveraging 30+ technology platforms and partnering with over 170 pharmaceutical companies across 140+ countries, Adalvo has established a scalable, repeatable model with a proven first-to-market track record. Headquartered in Switzerland and backed by EQT, Adalvo is a trusted partner in bringing complex pharmaceutical products to global markets and is committed to making a difference for patients around the world. First to market, built to last. For more information, visit Adalvo.
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Amneal Contact
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