Aurobindo Pharma Gains USFDA Nod for Diabetes Drug

Aurobindo Pharma received final USFDA approval to market its generic dapagliflozin tablets for type 2 diabetes. The drugs, equivalent to AstraZeneca's Farxiga, will be produced by its subsidiary APL Healthcare Ltd and launched immediately. The product enjoys 180 days of marketing exclusivity.

Aurobindo Pharma has received the green light from the US Food & Drug Administration to produce and market its dapagliflozin tablets, a medication aimed at managing blood sugar levels in type 2 diabetes patients.

The approved generic medication is bioequivalent and therapeutically equivalent to AstraZeneca's Farxiga and will be available in 5 mg and 10 mg strengths, according to Aurobindo's announcement filed on Tuesday. Production will take place at APL Healthcare Ltd, a wholly-owned subsidiary.

Aurobindo is among the first to submit a substantially complete ANDA for this drug, securing 180 days of shared generic marketing exclusivity. The market size for the drug is estimated at USD 10.2 billion, based on IQVIA's February 2026 data.

(With inputs from agencies.)