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Tentative Xeljanz XR Approval Among Several For Zydus Cadila

Final Gilenya Approval Also In The Bag

Executive Summary

Zydus Cadila has clocked up two tentative and four final abbreviated new drug application approvals in a short amount of time, including for Boehringer Ingelheim’s Jentadueto and the discontinued verapamil hydrochloride for injection.

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Hatch-Waxman cases filed by Pfizer against Micro Labs and Zydus Cadila over generic versions of Pfizer’s Xeljanz/Xeljanz XR will not move to trial, following settlement agreements covering two patents expiring in March 2023 and December 2025.

Sole Challenger HEC Beaten On US Gilenya Patent

Imminent generic competition to Novartis’ Gilenya blockbuster in the US now seems impossible after a US district court held that the company’s dosage-regimen patent was both valid and infringed by HEC’s ANDA product. The Chinese firm may yet appeal the decision.

PTAB rules Gilenya dosing patent is valid

Attempts to bring generics of Novartis’ Gilenya (fingolimod) blockbuster to the US market eight years ahead of schedule have failed for now, with the US Patent Trial and Appeal (PTAB) ruling that a dosing patent shielding the multiple sclerosis drug should stand, rejecting challenges from Apotex, Argentum, Sun Pharma and Teva.

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