US Food and Drug Administration (US FDA) has accepted two Abbreviated New Drug Applications (ANDAs) of Sandoz for review, marking an important milestone in the company's efforts to introduce generic versions of tirzepatide in the United States.
The applications cover generic tirzepatide autoinjectors developed entirely through Sandoz's in-house research and development program. If approved, the products could become among the first generic alternatives to Mounjaro® and Zepbound®, expanding access to one of the fastest-growing classes of medicines used for diabetes and obesity.
According to the company, the proposed generic medicines seek approval for all currently approved indications of the reference products. These include improving blood sugar control in adults and children aged 10 years and older with type 2 diabetes, as well as chronic weight management in adults with obesity or overweight accompanied by at least one weight-related health condition. The applications also include the indication for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity.
Claire D'Abreu-Hayling, President of Generics Development and Chief Scientific Officer at Sandoz, said the FDA acceptance demonstrates the company's growing capabilities in developing complex GLP-1 therapies internally. She noted that increasing competition in this therapeutic area is essential to improving patient access as the prevalence of obesity and diabetes continues to rise globally.
The company highlighted that the generic tirzepatide program combines its expertise in small-molecule medicines, drug-device combination products, and advanced biologics development techniques. This integrated approach is expected to support the commercialization of affordable alternatives once market exclusivity and patent barriers are resolved.
Sandoz views GLP-1 medicines as a major long-term growth opportunity. The company estimates that branded medicines worth more than USD 650 billion are expected to lose patent protection over the next decade, creating significant opportunities for generic and biosimilar manufacturers.
To strengthen its position in this rapidly expanding market, Sandoz is building a global GLP-1 development pipeline through a combination of in-house innovation and strategic manufacturing and development partnerships. The company says this strategy will help optimize investments while expanding patient access to affordable medicines worldwide.
Sandoz currently markets approximately 1,300 generic medicines globally and has around 400 additional generic products in various stages of development.
If the FDA ultimately approves the applications, generic tirzepatide could significantly increase competition in the rapidly growing GLP-1 market, potentially lowering treatment costs for millions of patients living with type 2 diabetes and obesity.
