Gilead Sciences Announces Notification of ANDA Filing for Ranexa®
June 10 2010 - 8:30PM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) today announced receipt of a
Paragraph IV Certification Notice Letter advising that Lupin
Limited submitted an Abbreviated New Drug Application (ANDA) to the
U.S. Food and Drug Administration (FDA) requesting permission to
manufacture and market a generic version of Ranexa® (ranolazine
extended-release tablets).
In the Notice Letter, Lupin alleges that all 10 patents
associated with Ranexa are invalid, unenforceable and/or will not
be infringed by Lupin’s manufacture, use or sale of the product
described in its ANDA submission.
Gilead is currently reviewing the Notice Letter and has 45 days
from the date of receipt to commence a patent infringement lawsuit
against Lupin. Such a lawsuit would restrict the FDA from approving
Lupin’s ANDA for up to 30 months or until a district court decision
that is adverse to Gilead, whichever occurs first. Ranexa is
currently protected by 10 patents, which are listed in the FDA’s
Approved Drugs Products List and all 10 patents would need to be
invalidated or expired before a generic version of Ranexa could be
marketed.
About Gilead
Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company’s mission is to advance the care of
patients suffering from life-threatening diseases worldwide.
Headquartered in Foster City, California, Gilead has operations in
North America, Europe and Australia.
Forward-Looking
Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, that are subject to risks, uncertainties and other factors,
including uncertainty related to whether Gilead will file a patent
infringement lawsuit against Lupin and whether such a lawsuit would
be successful. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the forward-looking statements. The reader is cautioned not to rely
on these forward-looking statements. These and other risks are
described in detail in Gilead's Quarterly Report on Form 10-Q for
the first quarter of 2010, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
Ranexa is a registered trademark of
Gilead Sciences, Inc.
For more information on Gilead,
please call the Gilead Public Affairs Department at 1-800-GILEAD-5
(1-800-445-3235) or visit www.gilead.com
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