Pharmaceutical Processing World

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

Noven Files Patent Infringement Lawsuit Against Actavis

By Pharmaceutical Processing | October 17, 2014

Noven Pharmaceuticals has filed a lawsuit in the U.S. District Court of New Jersey against Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Andrx Corp., and Actavis, Inc. for infringement of certain Noven patents.

The lawsuit was filed as a result of Actavis submitting an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) in which Actavis is seeking approval to market and sell a generic version of Brisdelle ® (paroxetine) capsules prior to the expiration of the Patents. The lawsuit reflects Noven’s commitment to vigorously defend its intellectual property rights against infringement.

Under the Hatch-Waxman Act, because Noven filed this patent infringement lawsuit within 45 days of receiving the Paragraph IV Certification Notice, the FDA cannot approve Actavis’ ANDA for 30 months (until March 2017), unless the district court decides before the 30 months pass that the Patents are invalid or not infringed. Brisdelle ® is protected by three Orange Book listed patents, which expire in 2017, 2023 and 2029, respectively. In addition, Brisdelle ® has marketing exclusivity that prevents FDA approval of an ANDA prior to June 2016.

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