Pharmaceutical Processing World

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

Shire Files Lawsuit Against Watson Pharmaceuticals

By Pharmaceutical Processing | April 6, 2011

Shire plc’s subsidiary Shire LLC has filed a lawsuit in the U.S. District
Court for the Southern District of New York against Watson Pharmaceuticals,
Inc. and its subsidiaries Watson Laboratories, Inc.-Florida, Watson Pharma,
Inc., Andrx Corporation, and Andrx Pharmaceuticals, L.L.C. for infringement of
Shire’s U.S. Reissue Patent No. RE 41,148, U.S. Reissue Patent No. RE 42,096
and U.S. Patent No. 6,913,768 and also for breach of contract.

The lawsuit results from an
Abbreviated New Drug Application (ANDA) recently filed by Watson for generic
versions of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg ADDERALL XR, pursuant to
which Watson provided notice that it would seek to market its generic products
before the expiration of Shire’s patents. The lawsuit alleges that all of
Watson’s generic strengths infringe the patents-in-suit. Pursuant to
Hatch-Waxman legislation, there will be up to a 30-month stay with respect to
Watson’s proposed generic products. The lawsuit also alleges that Watson has
violated existing settlement and license agreements between Shire and Watson,
signed in November 2007, arising from an ANDA that Watson filed in 2006, which
also sought approval to market generic versions of ADDERALL XR.

Shire submitted a Citizen
Petition (CP) to the FDA in October 2005 requesting that the FDA impose
stricter bioequivalence standards before approving any ANDA for ADDERALL XR.
The FDA responded that the CP raised “complex issues” and has not
resolved the matter. The FDA has not approved any ANDA for ADDERALL XR.

 

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