Zydus Knocked Back On Farxiga In US As Brand Continues To Grow
US Court Finds Key Patent Is Not Invalid As Obvious
Zydus Cadila has failed to prove to a US court that a US patent expiring in October 2025 that shields AstraZeneca’s Farxiga (dapagliflozin) SGLT2 inhibitor is obvious, keeping the firm’s proposed ANDA product off of the market for now.
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Zydus Cadila sees 40-50% growth continuing in its biosimilars business, with plans for launches in Latin America. Its Kadcyla biosimilar is faring well and after helping the company gain the top spot in India, could also move to clinical trials in the US.
Zydus Cadila’s single-dose nelarabine injection (250mg/50ml) will enjoy 180 days of competitive generic therapy market exclusivity following approval from the US FDA, as the first approved rival to Novartis’ Arranon brand.
AstraZeneca’s SGLT2 inhibitor produced 50% growth in Q1, and its new chronic kidney disease approval will give it an edge over Lilly and Boehringer’s Jardiance.