RANBAXY AND
GLAXOSMITHKLINE ENTER INTO AN AGREEMENT TO SETTLE VALACYCLOVIR
U.S. PATENT LITIGATION
RANBAXY TO LAUNCH VALACYCLOVIR HYDROCHLORIDE
TABLETS IN LATE 2009 WITH 180 DAYS EXCLUSIVITY
Princeton, NJ – July 26, 2007
Ranbaxy Laboratories Limited (RLL) announced today that
the Company has reached an agreement with GlaxoSmithKline
(GSK) resulting in a dismissal of their U.S. litigation
with regard to Valtrex® (Valacyclovir Hydrochloride
tablets). The lawsuit in the U.S. was related to GSK’s
U.S. Patent No. 4,957,924, covering Valacyclovir Hydrochloride
which is used in the treatment of herpes virus infection.
Under the agreement, Ranbaxy will enter
the U.S. market in late 2009, whereby as the first generic
company to file, it will enjoy a 180 days sales exclusivity.
Ranbaxy has also obtained a license to GSK’s U.S.
Patent Nos. 5,879,706 and 6,107,302, listed in the Orange
Book for Valacyclovir. The total annual market sales
of Valtrex were around $1.3 Bn (source IMS – MAT:
Dec. 2006).
In early February 2007, Ranbaxy received
a final approval from the U.S. FDA to market and manufacture
Valacyclovir Hydrochloride tablets.
Ranbaxy will continue to pursue a strategy
to effectively leverage and monetize its pipeline of
First-to-File (FTF) opportunities. The Company believes
that it has a FTF status on approximately 20 Para IV
ANDA filings, representing a market size of $26 Bn valued
at innovator prices.
Ranbaxy Laboratories Limited, the largest pharmaceutical
company in India, 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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