1. Scrip
  2. >>Archive

Teva and Cobalt challenge key US patents for Sepracor's Lunesta

 
• By Nancy Faigen

Sepracor has received notice that Teva Pharmaceutical Industries and Cobalt Laboratories have filed ANDAs for generic versions of the sleep agent Lunesta (eszopiclone) tablets, which gained US regulatory clearance in December 2004.

Sepracor has received notice that Teva Pharmaceutical Industries and Cobalt Laboratories have filed ANDAs for generic versions of the sleep agent Lunesta (eszopiclone) tablets, which gained US regulatory clearance in December 2004.

Both ANDAs contain paragraph IV certifications alleging that one or more of Sepracor's patents listed in the FDA's Orange Book...

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 Archive

Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

More from Scrip

Quotables: Pharma Leaders On The Month’s Hot Topics

 
• By Anabel Costa-Ferreira

The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.

Cipla Revs Up Biosimilars Engine Amid Winds Of Regulatory Change

 
• By Anju Ghangurde

Cipla’s partnered filgrastim biosimilar is expected to debut in the US in Q2 FY26 and the Indian firm expects an investment return ratio for its biosimilar engine “not too far” from that of a complex generic product amid an enabling regulatory environment.

With Planned US Facility Acquisition, Celltrion Looks To Avoid US Pharma Tariffs

 
• By Jung Won Shin

Celltrion is set to acquire a US biologics manufacturing facility that will "eliminate" its US tariff risks and provide a ready-made production base for future expansion.