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Bye, Bye Byetta: Teva To Take AstraZeneca's GLP-1 Agonist Generic Two Years Early

 
• By Brenda Sandburg

First in class is the first to fall, and Byetta could go even earlier than the October 2017 date set in Teva settlement since AstraZeneca still faces a generic challenge from Amneal – and a direct attack on its patents from Sanofi.

Teva Pharmaceutical Industries Ltd.'s patent infringement settlement with AstraZeneca PLC allows it to launch a generic version of Byetta (exenatide) in the U.S. two years and three months before expiration of the last patent covering the GLP-1 agonist.

Teva announced in a June 23 release that it had settled litigation relating to seven AstraZeneca patents covering the diabetes...

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US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.