Adalvo and Amneal Pharmaceuticals today 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® and Zepbound®, seek approval for all approved autoinjector presentations and indications of the respective reference products for the treatment of type 2 diabetes and chronic weight management. 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.
Adalvo and Amneal are jointly developing these generic tirzepatide injectables 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.
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Mounjaro® and Zepbound® are registered trademarks of Eli Lilly and Company.