Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

FDA Approves Generic Lidoderm

By Drug Discovery Trends Editor | August 30, 2012

NEW YORK (AP) – Federal regulators have approved Watson Pharmaceuticals’ generic version of Endo Health Solutions Inc.’s Lidoderm pain patch.

Watson’s version of the patch was approved on August 23. Under terms of a lawsuit settlement between Watson and Endo, Watson can begin selling its generic in September 2013. The Parsippany, N.J., company said it believes competing generics will be barred from the market for 180 days after its product goes on sale.

Endo said it is disappointed with the the Food and Drug Administration’s decision. The Lidoderm patch is its biggest-selling product.

Endo had sued Watson over patent infringement. The companies settled their dispute in late May, and Watson agreed not to market its generic until Sept. 15, 2013. Endo will get royalties of 25 percent on early sales of Watson’s generic. It will also provide $96 million in branded Lidoderm to Watson over the first 8 months of 2013.

Watson says U.S. sales of Lidoderm are $1.2 billion.

Analysts said the approval is bad news for Endo, but it’s not a surprise. Stifel Nicolaus analyst Annabel Samimy said the approval is the “worst case” scenario for Endo, but added that it is “fully priced into the stock and already reflected in consensus views” for the company.

Samimy and other analysts added that other companies are seeking approval for their own generics. Those could go on sale in early 2014 and further cut into Endo’s revenue. Roth Capital Partners analyst Scott Henry said he thinks Endo’s Lidoderm revenue will fall to about $500 million in 2014.

Date: August 24, 2012
Source: Associated Press


Filed Under: Drug Discovery

 

Related Articles Read More >

Tiffany Hurd
CB Therapeutics biz dev lead sees upside for psychedelics in mental health and beyond
Pharmacovigilance
A new era of pharmacovigilance: Worldwide master key for drug safety monitoring
Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Novartis in the Pharma 50
Novartis to cut up to 8,000 positions

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50