Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Intellectual Property

Set Alert for Intellectual Property

‘Imminent’ Gilenya ANDA Launches Halted By US Supreme Court

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.

Generic Drugs Legal Issues

US Federal Circuit Will Not Stand In Way Of Gilenya Generics

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.

Generic Drugs Legal Issues

Pfizer Overcomes Attempt To Block Lexiscan ANDA

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.

Generic Drugs Legal Issues

Viatris Loses US Challenge To Januvia And Janumet Patents

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.

Generic Drugs Legal Issues

Sandoz Delivers Denosumab Data As Biogen Sues On Tysabri

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.

Biosimilars Clinical Trials

Gilenya Generics May Be Imminent Amid US Federal Circuit Snub

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.

Generic Drugs Intellectual Property

Viatris Keeping Powder Dry On Symbicort With Key Ruling Imminent

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.

Generic Drugs Intellectual Property

EU Gears Up For Compulsory Licensing Reform

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.

Intellectual Property Europe

Five Firms Settle With Gilead Over Tenofovir Alafenamide

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.

Intellectual Property Legal Issues
See All
UsernamePublicRestriction

Register