Biocon Pharma and Zydus Lifesciences receive U.S. FDA approval for generic dapagliflozin tablets 5 mg and 10 mg for type 2 diabetes, with Zydus eligible for 180-day shared exclusivity.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
Biocon Pharma Limited, a subsidiary of Biocon Limited, and Zydus Lifesciences Limited have received approval from the U.S. Food and Drug Administration (FDA) for dapagliflozin tablets in 5 mg and 10 mg strengths for adults with type 2 diabetes mellitus.
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The therapy is also approved to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors.
Biocon Expands Diabetes Portfolio
The approval strengthens Biocon’s expanding diabetes portfolio, which includes oral solid dosage formulations, biosimilar insulin, and complex GLP-1 peptides. The company stated that this integrated portfolio is designed to address evolving treatment needs for people living with diabetes globally.
Biocon’s dapagliflozin tablets will be manufactured at the company’s FDA-approved facilities in compliance with global quality and regulatory standards.
Zydus Secures Shared Generic Exclusivity
Zydus Lifesciences also received final FDA approval for dapagliflozin tablets, referencing Farxiga® tablets (5 mg and 10 mg). With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for the product.
The company will manufacture dapagliflozin tablets at its formulation manufacturing facility located in the Special Economic Zone in Ahmedabad.
Market Opportunity and Portfolio Update
According to IQVIA MAT data for February 2026, dapagliflozin tablets recorded annual sales of approximately USD 10.2 billion in the United States, highlighting a significant market opportunity for generic entrants.
Following this approval, Zydus stated that it now has 436 approvals and has filed 505 abbreviated new drug applications (ANDAs) since it began filing in FY 2003–04.
Reference
Zydus receives final approval from USFDA for Dapagliflozin Tablets, 5 mg and 10 mg, 08 April 2026, https://www.zyduslife.com/investor/admin/uploads/21/83/Zydus-receives-final-approval-from-USFDA-for-Dapagliflozin-Tablets–5-mg-and-10-mg.pdf
Biocon Pharma Limited Receives U.S. FDA Approval for Dapagliflozin Tablets, 5 mg and 10 mg, 08 April 2026, https://www.biocon.com/docs/Dapagliflozin-Tablets-US-FDA-Approval_final_080426.pdf
About the Writer
Vennela Reddy, BPharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.
