Inventia Healthcare has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for dapagliflozin tablets in 5 mg and 10 mg strengths and has launched the product in the United States on the first day of approval.

The approved generic tablets have been found to be bioequivalent and therapeutically equivalent to AstraZeneca’s reference drug, Farxiga (dapagliflozin), which is widely used to treat type 2 diabetes and reduce the risk of heart failure-related hospitalisations.

The approval allows Inventia to market dapagliflozin tablets for two key indications: improving glycaemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise and reducing the risk of hospitalisation for heart failure in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors.

Inventia said the approval and immediate launch mark a major step in its strategy to expand access to affordable, high-quality medicines in the US market. The company highlighted its strong regulatory expertise, manufacturing capabilities and patient-focused approach as key factors behind the milestone.

According to IQVIA MAT data for December 2025, annual sales of dapagliflozin tablets in the United States were approximately USD 10.5 billion, indicating a significant market opportunity for the generic product.

Inventia also stated that it is eligible for 180 days of shared generic drug exclusivity for dapagliflozin tablets, subject to applicable statutory provisions. This exclusivity period could provide the company with an important commercial advantage in the near term.

Inventia Healthcare, which has over four decades of experience in pharmaceutical development and manufacturing, operates in more than 50 countries. The company is known for its expertise in complex generics and advanced oral drug delivery technologies, with a strong focus on cardiovascular, metabolic, central nervous system and gastrointestinal therapies.

The US launch of generic dapagliflozin strengthens Inventia’s presence in the global pharmaceutical market and supports its broader goal of making critical chronic disease treatments more accessible and affordable for patients.