RANBAXY AND PFIZER SETTLE LIPITOR LITIGATION
WORLDWIDE
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; Princeton,
NJ, USA – June 18 , 2008
-- 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,
with180 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.
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