RANBAXY AND ASTELLAS/BOEHRINGER
INGELHEIM ENTER INTO AN AGREEMENT TO RESOLVE TAMSULOSIN
U.S. PATENT LITIGATION
Ranbaxy to Launch on an Exclusive Basis in 2010
Gurgaon, Haryana, India; Princeton, NJ, U.S.
– November 8, 2007
Ranbaxy Laboratories Limited (Ranbaxy)
announced today that the Company has reached an agreement
with Astellas/Boehringer Ingelheim to stipulate a remand
of the pending Federal Circuit appeal and subsequent
vacatur of the District Court decision in regards to
Flomax® (Tamsulosin capsules). The case between
Ranbaxy and Astellas/Boehringer Ingelheim has been dismissed
without prejudice. The lawsuit in the U.S. was related
to Astellas’ U.S. Patent No. 4,703,063 (‘063
patent), covering Tamsulosin and its use in the treatment
for functional symptoms of BPH (benign prostatic hyperplasia).
Under the agreement, Ranbaxy will enter
the U.S. market on March 2, 2010, eight weeks prior
to expiration of the pediatric exclusivity, which is
likely to be granted to the innovator company. During
this time period of pediatric exclusivity, Ranbaxy will
be the only generic manufacturer to commercialize this
product in the U.S. market. Ranbaxy believes that its
Tamsulosin ANDA is the first substantially complete
ANDA with a Paragraph IV certification to the ‘063
patent. The total annual sales of Flomax are estimated
to be USD 1.2 Bn (source IMS).
On June 20, 2007, Ranbaxy received
tentative approval from the U.S. FDA in regards to its
Tamsulosin ANDA No. 77-451.
Ranbaxy will continue to pursue a strategy
to effectively optimize its pipeline of First-to File
(FTF) opportunities. The Company believes that it has
a FTF status on approximately 17 Paragraph IV ANDA filings
representing a market size of ~ USD 26 Bn valued at
innovator prices.
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, headquartered 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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