FDA clears first generics of AstraZeneca’s Farxiga, opening $8.5bn market to rivals

The US Food and Drug Administration has approved the first generic versions of Farxiga, marking a significant shift for one of AstraZeneca’s top-selling diabetes treatments.

The regulator granted approvals to 14 manufacturers, including Teva and Sandoz, alongside several Indian drugmakers such as Aurobindo Pharma, Biocon, Cipla, Lupin Limited and Zydus Lifesciences. The approvals cover both 5mg and 10mg formulations of dapagliflozin.

Farxiga, part of a class of drugs known as SGLT2 inhibitors, is prescribed to improve glycaemic control in patients with Type 2 diabetes. It is also used to reduce the risk of hospitalisation for heart failure among patients with established cardiovascular disease or multiple risk factors.

The move opens the door to increased competition in a market that has been dominated by branded therapies. Farxiga generated $8.5bn in global sales last year, including $1.7bn in the US, underscoring its importance to AstraZeneca’s portfolio.

Originally approved by the FDA in 2014, dapagliflozin has since become a cornerstone treatment in diabetes and cardiovascular care. Generic versions were launched in the UK and Japan in the latter half of last year, signalling a broader shift towards lower-cost alternatives across key markets.