Zydus Cadila has scooped the first US Food and Drug Administration approval for a generic version of AstraZeneca’s Farxiga (dapagliflozin), “the fastest growing SGLT2 inhibitor globally.” However, an unfavorable patent-infringement ruling handed down last October looks set to keep the Indian firm’s ANDA product from the market for several years.
Patent Blocks Zydus After Landmark US Approval For Dapagliflozin
AstraZeneca’s Farxiga Brand Set To Stand Until October 2025
With more than a dozen ANDA sponsors chasing AstraZeneca’s Farxiga SGLT2 inhibitor, Zydus Cadila has scooped the first FDA approval for a generic version of the game-changing type 2 diabetes drug. However, a key US patent stands in its way.
