Gilead Sciences Announces Notification of ANDA Filing for Viread®
January 27 2010 - 9:20PM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) today announced receipt of a
Paragraph IV Certification Notice Letter advising that Teva
Pharmaceuticals 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 Viread®
(tenofovir disoproxil fumarate).
In the Notice Letter, Teva alleges that three patents associated
with tenofovir disoproxil – U.S. Patent Numbers 5,922,695;
5,977,089; and 6,043,230; and one patent associated with tenofovir
disoproxil fumarate – U.S. Patent Number 5,935,946 – owned by
Gilead Sciences are invalid, unenforceable and/or will not be
infringed by Teva’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 Teva. Such a lawsuit would restrict the FDA from approving
Teva’s ANDA for up to 30 months or until a district court decision
that is adverse to Gilead, whichever occurs first.
Viread is currently protected by four patents, which are listed
in the FDA’s Approved Drug Products List, and all four patents
would need to be invalidated or expired before a generic version of
Viread could be marketed. The U.S. Patent & Trademark Office
(PTO) confirmed the patentability of these four Viread patents in
2008.
Gilead currently has a lawsuit pending against Teva in response
to Teva’s attempts to seek approval for generic versions of
Truvada® (emtricitabine and tenofovir disoproxil fumarate) and
Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg) based on allegations that two
emtricitabine patents are invalid, unenforceable and/or will not be
infringed by Teva’s manufacture, use or sale of its generic
product.
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 another
patent infringement lawsuit against Teva and whether such a lawsuit
or the lawsuit that is currently pending related to Teva’s ANDA
filing for Truvada and Atripla 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 2009, 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.
Viread and Truvada are registered
trademarks of Gilead Sciences, Inc.
Atripla is a registered trademark of
Bristol-Myers Squibb & Gilead Sciences, LLC.
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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