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.
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.
With a tentative FDA approval secured in October 2020, Zydus has obtained full approval following the expiry of certain data exclusivity on 22 February
A free trade agreement struck between the UK and India could over “significant benefits for the generic and biosimilar sectors,” Medicines UK believes. The off-patent industry association has also suggested further avenues for collaboration between the two governments on regulatory pathways and supply security.
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Dr. Reddy's Laboratories preps for potential US tariffs, focusing on sustaining product supply and collaborating with customers on inventories. A recent US plant sale, the firm stressed, was unrelated to tariffs and underlines its openness to ‘make in the US’, where it launched 18 products in fiscal 2025.
