Gilead Sciences Announces Notification of ANDA Filing for Tamiflu®
February 07 2011 - 5:00PM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) today announced receipt of
a Paragraph IV Certification Notice Letter advising that Natco
Pharma 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 Tamiflu®
(oseltamivir phosphate) 75 mg capsules.
In the Notice Letter, Natco alleges that a patent associated
with Tamiflu – U.S. Patent Number 5,763,483 – owned by Gilead
Sciences is invalid, unenforceable and/or will not be infringed by
Natco’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 Natco. Such a lawsuit would restrict the FDA from approving
Tamiflu’s ANDA for up to 30 months or until a district court
decision that is adverse to Gilead, whichever occurs first. Tamiflu
is protected by this patent, which is listed in the FDA’s Approved
Drug Products List, and the patent would need to be invalidated or
not infringed upon before a generic version of Tamiflu could be
marketed without liability for patent infringement.
Tamiflu was invented by Gilead Sciences and licensed to F.
Hoffmann-La Roche Ltd in 1996.
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 Natco 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 third 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.
Tamiflu is a registered trademark of
Hoffmann-La Roche Inc.
For more information on Gilead Sciences, please
visit www.gilead.com or call the Gilead Public Affairs Department
at 1-800-GILEAD-5 (1-800-445-3235).
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