Alvogen Settles With Celgene Over US Revlimid

Alvogen can sell in the US generic lenalidomide on a volume-limited basis after March 2022, and without volume limitations in early 2026, after settling patent litigation with Celgene relating to the originator’s Revlimid. Dr Reddy's has also settled in Canada.

DollarSign
Alvogen can sell generic lenalidomide in the US after 2022 • Source: Shutterstock

Alvogen and its subsidiary Lotus Pharmaceuticals have settled patent litigation with Celgene concerning the originator’s Revlimid (lenalidomide). This allows for generic entry of the multiple myeloma treatment on a confidential date.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Generics

US Bill Recap: Senate Judiciary Committee Offers Fresh Start For Reintroduced Off-Patent Drug Bills

 

The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.

Jazz Agrees To Fork Out $145m To Resolve Most Xyrem ‘Pay-For-Delay’ Claims

 
• By 

Jazz has agreed a nine figure settlement agreement in the US with purchasers of its Xyrem blockbuster following claims that it illegally delayed generic competition to the blockbuster treatment for narcolepsy via patent-litigation settlement agreements with several ANDA sponsors.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Kabi Pens Agreement To Launch Generic Exparel In 2030 – With A Volume Limit

 
• By 

With sales of $550m last year and a high barrier to entry, Exparel marks an intriguing target for abbreviated new drug application sponsors. Having shot down a US patent last year and won US FDA approval for its ANDA, Jiangsu Hengrui’s US eVenus Pharmaceutical Laboratories subsidiary and partner Fresenius Kabi have just reached a settlement agreement.

More from Products

Kabi Pens Agreement To Launch Generic Exparel In 2030 – With A Volume Limit

 
• By 

With sales of $550m last year and a high barrier to entry, Exparel marks an intriguing target for abbreviated new drug application sponsors. Having shot down a US patent last year and won US FDA approval for its ANDA, Jiangsu Hengrui’s US eVenus Pharmaceutical Laboratories subsidiary and partner Fresenius Kabi have just reached a settlement agreement.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By 

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Spanish Authorities Investigate Sandoz Over Information-Sharing

 
• By 

Spanish competition regulator the CNMC has announced an investigation into Sandoz and its Bexal subsidiary – as well as Alliance Healthcare España and Bluetab Solutions – over sharing sensitive commercial information relating to pharmacy orders for generics.