1. Scrip

Cephalon sues Mylan and Teva over key US Amrix patent

 
• By Nancy Faigen

Cephalonand Eurandhave filed suit in a US district court in Delaware against Barr PharmaceuticalsandMylan Laboratories, alleging patent infringement related to their generic versions of the muscle relaxant Amrex (cyclobenzaprine HCl) extended-release capsules, thus triggering the 30-month stays of approval while the legal challenge is fought. The brand companies claim infringement of Eurand's US patent covering the extended-release product, No 7,387,793, which is the only Orange Book-listed patent for the product, expiring in February 2025. Barr and Mylan have filed paragraph IV challenges to the patent, claiming that the patent is invalid, unenforceable and/or will not be infringed by its manufacture, and Mylan claims it has first-filer status.

Cephalonand Eurandhave filed suit in a US district court in Delaware against Barr PharmaceuticalsandMylan Laboratories, alleging patent infringement related to their generic versions of the muscle relaxant Amrex (cyclobenzaprine HCl) extended-release capsules, thus triggering the 30-month stays of approval while the legal challenge is fought. The brand companies claim infringement of Eurand's US patent covering the extended-release product, No 7,387,793, which is the only Orange Book-listed patent for the product, expiring in February 2025. Barr and Mylan have filed paragraph IV challenges to the patent, claiming that the patent is invalid, unenforceable and/or will not be infringed by its manufacture, and Mylan claims it has first-filer status.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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
Start Free Trial

Already a subscriber?

More from Business

Asia Deal Watch: SunRock, Escugen Collaborate On CCR9-Targeted ADC

 
• By Joseph Haas, Lisa Takagi, Sushmita Panda, and Xu Hu

Axcelead/Lotte Biologics/Kanaph and NextCure/Simcere also unveil ADC-focused pacts, plus deals involving Avata/Oceanus, GSK/Bharat Biotech, Cullinan/Genrix and more.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 
• By Edwin Elmhirst

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

China Signals Restarting IPOs For Unprofitable Biotechs

 
• By Dexter Jie Yan

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

BIO Notebook: Woodcock Calls For Doing The Right Thing, Dealmaking Remains Constrained

 
• By Mandy Jackson, Joseph Haas, and Sarah Karlin-Smith

Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

More from Scrip