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In a dramatic twist, Gilenya ANDA sponsors are now unable to launch their generic products in the US after the US Supreme Court intervened in favor of originator Novartis, superseding the US Federal Circuit.
ANDA sponsors targeting Novartis’s Gilenya have been informed by the US Court of Appeals for the Federal Circuit that at an ‘at-risk’ launch is possible, after the originator’s latest petition to the court was denied as it seeks a ruling from the US Supreme Court.
Injunctive relief has been provided against Hospira’s regadenoson ANDA product only until early October, allowing the US-based generics sponsor to close in on a potential launch.
Viatris’ attempts to deliver US generic versions of sitagliptin and sitagliptin/metformin ahead of patent expiry has failed for now, with an unfavorable judgment from a district court in West Virginia. More than 20 ANDA sponsors have opted to settle litigation with originator Merck.
Having previously identified itself as the frontrunner in the race to launch a biosimilar to Amgen’s Prolia, Sandoz has now delivered positive confirmatory data, shortly after being sued in the US over its Polpharma-partnered proposed Tysabri biosimilar.
Are US Gilenya generics set to flood the US market? HEC Pharm is hoping so, following a favorable Federal Circuit denial. However, in a bid to maintain its monopoly and avoid a potential $300m hit to its top line, Novartis is taking its fight to the US Supreme Court.
In the coming days, Viatris expects to hear back from a court in West Virginia over its legal tussle with AstraZeneca on Symbicort IP. The US-based player has intimated that it may launch the product dependent on the court’s verdict.
The European Commission has laid out a number of possibilities for changing the EU framework on compulsory licensing to improve the availability of products in health emergencies. The options include extending the scope of compulsory licences beyond patents to other forms of protection such as data exclusivity.
Five generics firms – Apotex, Cipla, Hetero, Lupin and Macleods – have settled US patent litigation with Gilead Sciences over the Descovy, Odefsey and Vemlidy brands that contain tenofovir alafenamide.
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