Navigation Links
Ranbaxy and Pfizer Settle Lipitor Litigation Worldwide
Date:6/18/2008

Ranbaxy Will Market Generic Atorvastatin in the U.S. With 180 Days

Exclusivity From Nov. 30, 2011

Agreement Also Resolves Caduet, Accupril Litigation in the US

GURGAON, Harayana, India and PRINCETON, N.J., June 18 /PRNewswire/ -- Ranbaxy Laboratories Limited (Ranbaxy), announced today that it has entered into an agreement with Pfizer Inc. to settle most of the patent litigation worldwide involving Atorvastatin (Lipitor), the world's most-prescribed cholesterol-lowering medicine. This decision will allow for an earlier introduction of a generic formulation that will benefit patients and many healthcare systems throughout the world. Lipitor is the world's largest selling drug with worldwide sales in 2007 of $12.7 billion.

The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal challenges to the Lipitor patents involving other generic manufacturers. However, as Ranbaxy was the first generic challenger to the listed Lipitor patents, it retains the right to the marketing exclusivity of 180 days in the United States. Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Atorvastatin and the fixed-dose combination of Atorvastatin-Amlodipine besylate in the United States effective Nov. 30, 2011.

Welcoming the development, Malvinder Mohan Singh, CEO and MD, Ranbaxy Laboratories Ltd., said, "This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes. It also provides certainty and visibility to the launch of Ranbaxy's Generic Atorvastatin, with 180-day market exclusivity in the US and an early entry in other markets. This will make the worlds largest selling drug more accessible to patients who will gain from the timely availability of an affordable quality option."

Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional 7 countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam.

In addition, the lawsuits between Pfizer and Ranbaxy regarding Atorvastatin will be dismissed in select countries and the lawsuits between Pfizer and Ranbaxy regarding the fixed dose combination product containing Atorvastatin and amlodipine will be dismissed in the U.S. and Ranbaxy will no longer contest the validity of Pfizer's patents in such countries. Such patent challenges by Ranbaxy regarding Lipitor have been underway in numerous markets since 2003.

The Atorvastatin patents involved in this agreement are the basic compound patent, which expires in the United States in 2010; the enantiomer patent, which expires in the United States in 2011; and various process and crystalline form patents, which expire in 2016 and 2017; and the combination patent for fixed-dose combination product which expires in 2018.

The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine besylate (presently marketed under the brand Caduet, which also contains crystalline Form I Atorvastatin), a fixed-dose combination product indicated for patients suffering from both high blood pressure and high levels of cholesterol. The patent for the fixed-dose combination expires in 2018. The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (in the U.S.) and Viagra (in Ecuador) and all patent litigation with Ranbaxy relating to generic formulation of Quinapril hydrochloride in the United States and Sildenafil in Ecuador.

Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania.

About Ranbaxy Laboratories Limited

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.

For further information please contact:

Ramesh L. Adige

Executive Director - Corporate Affairs and Global Corporate Communications

Ranbaxy Laboratories Ltd.

Plot 90, Sector 32, Gurgaon

Haryana122001, India

Tel: +91-124-4135000

e-mail: ramesh.adige@ranbaxy.com

or

Raghu Kochar

Director - Corporate Communications

Ranbaxy Laboratories Ltd.

Plot 90, Sector 32, Gurgaon

Haryana122001, India

Tel: +91-124-4135141

Mobile: 9811617256

e-mail: raghu.kochar@ranbaxy.com

or

Krishnan Ramalingam

Sr. Manager - Corporate Communications

Plot 90, Sector 32, Gurgaon

Haryana122001, India

Tel: +91-124-4135143

Mobile: 9810042540

e-mail: krishnan.ramalingam@ranbaxy

or

Chuck Caprariello

Vice President, Corporate Communications and Government Affairs

Ranbaxy Inc.

600 College Road East

Princeton, NJ 08540

Tel: 609-720-5615

Mobile: 609-462-7354

e-mail: chuck.caprariello@ranbaxy.com


'/>"/>
SOURCE Ranbaxy Laboratories Limited
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Ranbaxy to Bring in Daiichi Sankyo as Majority Partner; Strategic Combination Creates Innovator and Generic Pharma Powerhouse
2. Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Oral Solution
3. Ranbaxy Gains Approval to Manufacture and Market Cefuroxime Axetil for Oral Suspension
4. Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Tablets (OTC), 5mg and 10mg
5. Ranbaxy Receives Tentative Approval For Valsartan Tablets
6. Ranbaxy First to Gain Approval to Manufacture and Market Clarithromycin for Oral Suspension, USP
7. Ranbaxy Gains Approval to Manufacture and Market Carvedilol Tablets in the U.S. Market
8. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
9. Novartis, Pfizer and Merck Take the Lead on Strong Relationships with Physicians, as Doctors Demand an Expanding Set of Services
10. Pfizers work on penicillin for World War II becomes a National Historic Chemical Landmark
11. AUDIO from Medialink and Pfizer: Free Programs for Uninsured Men and Women Who Need Help Paying for Medicine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect ... videos a whole new perspective by using the title layers in ProSlice Levels ... , ProSlice Levels contains over 30 Different presets to choose from. FCPX ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to a ... new, often overlooked aspect of head lice: the parasite’s ability to live away from a ... occurrence, but a necessary one in the event that lice have simply gotten out of ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 2016 The Academy of Managed Care Pharmacy ... that would allow biopharmaceutical companies to more easily share ... formulary and coverage decisions, a move that addresses the ... The recommendations address restrictions in the sharing ... drug label, a prohibition that hinders decision makers from ...
(Date:6/24/2016)... , June 24, 2016  American Respiratory Labs (ARL), a ... now able to perform sophisticated lung assessments in patients, homes, thanks ... Inc. Patients are no longer limited to having ... PRO ® , ARL patients like Jeanne R. of ... the comfort of her own home. ...
(Date:6/24/2016)... , June 24, 2016 ... Market by Type (Standard Pen Needles, Safety Pen Needles), ... (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) ... MarketsandMarkets, This report studies the market for the forecast ... to reach USD 2.81 Billion by 2021 from USD ...
Breaking Medicine Technology: