RANBAXY AND ASTRAZENECA REACH AGREEMENT IN
ESOMEPRAZOLE PATENT LITIGATION
Companies Also Sign Manufacturing and Distribution
Agreement
Gurgaon, India; Princeton, NJ –
April 15, 2008 -- Ranbaxy Pharmaceuticals Inc. (RPI),
a wholly owned subsidiary of Ranbaxy Laboratories Limited
(RLL), announced today that it has reached several agreements
with AstraZeneca. Two of these agreements concern Esomeprazole
magnesium capsules. The third agreement pertains to
Omeprazole 40mg tablets, and the fourth agreement pertains
to Felodipine ER capsules. All of the agreements are
specific to the U.S. market.
The agreement settles the patent infringement litigation
filed by AstraZeneca following Ranbaxy’s submission
to the United States Food & Drug Administration
of an Abbreviated New Drug Application for a generic
version of Esomeprazole magnesium. Under the settlement
agreement, Ranbaxy concedes that all six patents asserted
by AstraZeneca in the patent litigation are valid and
enforceable.
The settlement agreement will allow
Ranbaxy to commence exclusive sales of a generic version
of Nexium under a license from AstraZeneca on May 27,
2014. During the 180-day period following the date,
RPI will distribute the only generic Esomeprazole magnesium
product in the U.S. market.
Ranbaxy has filed a Consent Judgment with the U.S. District
Court for the District of New Jersey reflecting the
terms of the settlement agreement. With the Court now
having entered the Consent Judgment, the settlement
agreement is final, and the patent infringement litigation
against Ranbaxy has been dismissed.
Merck & Co., Inc., through KBI Inc. and KBI-E and
under the terms of Merck's restructured partnership
with AstraZeneca announced in 1998, has also entered
into the settlement agreement.
“We are pleased with the agreement which will
provide certainty as to the launch of a generic formulation
of Esomeprazole magnesium in the U.S. market,“
according to Malvinder M. Singh, CEO and Managing Director
of Ranbaxy Laboratories Ltd.
Manufacturing Agreements
AstraZeneca and Ranbaxy have separately entered into
an agreement under which Ranbaxy will formulate a significant
portion of AstraZeneca’s U.S. supply of Nexium
from May 2010, including provisions for the manufacture
of Esomeprazole magnesium, the Active Pharmaceutical
Ingredient (API) from May 2009.
Distribution Agreements
AstraZeneca and Ranbaxy have also entered into two separate
agreements designating Ranbaxy as the U.S. distributor
for the authorized generic versions of Felodipine Capsules
and Omeprazole 40mg Tablets. Ranbaxy will be compensated
for its distribution services on standard commercial
terms.
In regards to the Distribution Agreements, Mr. Singh
added, “It is anticipated that these products
will fulfill the needs of the U.S. healthcare system
in providing a generic formulation as an option, in
addition to the brand. This will support the requirement
of patients prescribed these medications, and supports
our long-term efforts to increase our product portfolio
of generic molecules to meet the needs of Americans.”
Esomeprazole magnesium belongs to a class of medicines
known as proton-pump inhibitors (PPIs). It works by
binding to, and inhibiting, the acid pumps of a particular
type of cell which is found in the stomach. In doing
so, it lowers the level of acidity in the stomach and
helps to heal erosions in the esophagus or ulcers in
the duodenum.
Esomeprazole magnesium is an effective treatment for
patients with gastroesophageal reflux disease (GERD),
but is particularly appropriate for those suffering
from persistent, recurrent GERD which can cause disruptive,
long-term symptoms. Esomeprazole magnesium has been
demonstrated to provide enduring relief from the impact
of GERD amongst patients.
Felodipine is a calcium antagonist
for the treatment of hypertension and angina.
Omeprazole was the first PPI and is
used for the short-term treatment of acid-related diseases
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville,
Florida, is a wholly owned subsidiary of Ranbaxy Laboratories
Limited (RLL), India’s largest pharmaceutical
company. RPI is engaged in the sale and distribution
of generic and branded prescription products in the
U.S. healthcare system.
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.
*Nexium® is a registered trademark of AstraZeneca
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