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US Court of Appeals Upholds Gilenya Compound Patent, Dealing A Blow To Ezra Ventures

 
• By Dean Rudge

Upholding the validity of Novartis’ Gilenya compound patent, a US Court of Appeals ensures that US-based Ezra’s generic fingolimod hydrochloride product will stay off the market until at least 2019. Generics players challenging the blockbuster multiple-sclerosis brand's patents have had mixed fortunes thus far.

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Gilenya compound patent is upheld as valid • Source: Shutterstock

Ezra Ventures remains barred from launching its generic of Novartis’ Gilenya (fingolimod hydrochloride) capsules until at least next year, after a US Court of Appeals affirmed that the originator’s key compound patent was valid through the end of its five-year patent extension.

Delaware District Judge Leonard Stark had in June last year held that US patent 5,604,229 was valid and infringed by Ezra’s abbreviated new drug application (ANDA), barring it from obtaining US Food and Drug Administration (FDA) approval for its application until patent expiry

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