Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Patent Litigation with Apotex

By Pharmaceutical Processing | April 23, 2008

Meda, through its wholly owned U.S. subsidiary, Meda Pharmaceuticals Inc., has entered into a settlement agreement with Apotex that resolves the U.S. patent litigation between the companies regarding Apotex’s proposed generic versions of Astelin&reg and Optivar&reg. Astelin&reg (azelastine hydrochloride nasal spray) is used for treatment of allergic and non-allergic rhinitis and Optivar&reg (azelastine hydrochloride ophthalmic solution) is used for treatment of allergic conjunctivitis. These products are protected in the U.S. by a patent that expires on 1 November 2010, with pediatric exclusivity extending until May 1, 2011. The settlement agreement resolves patent infringement actions filed by Meda after Apotex’s submission of ANDAs (Abbreviated New Drug Applications) to the FDA for generic versions of Astelin&reg and Optivar&reg in 2006 and 2007, respectively. Under the settlement agreement, Apotex admits infringement of Meda’s patent. Given the settlement agreement, the parties will jointly request that scheduled trials regarding Apotex’s proposed generic version of Astelin&reg in May 2008 and proposed generic version of Optivar&reg in February 2009 be adjourned and the actions closed. The settlement agreement allows Apotex to launch a generic version of Astelin&reg, under a license from Meda, on 1 March 2010. In such case, Apotex will pay 32.5% of their net sales of this product to Meda until 1 February 2011. The agreement also allows Apotex to launch a generic version of Optivar&reg, under license from Meda, on December 1, 2009, without further payments to Meda. “This settlement agreement brings clarity to Meda’s intellectual property rights on the U.S. patent for Astelin&reg and Optivar&reg,” said Anders Lonner, CEO Meda. In compliance with U.S. law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and Department of Justice and is subject to their review.

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

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.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 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 Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE