May 24, 2007
For Immediate Release
Apotex Launches Generic Norvasc®
Weston,
FL (May 24, 2007) — Apotex Corp. announced today that it
has launched amlodipine besylate tablets (2.5 mg, 5 mg, and 10 mg), the
generic equivalent of Pfizer’s Norvasc®. The launch follows Monday’s
issuance of the mandate by the US Court of Appeals for the Federal
Circuit’s decision of March 22 invalidating Pfizer’s US Patent 4,879,303
(the ‘303 patent) covering amlodipine besylate. The decision came in an
action brought by Pfizer against Apotex. Apotex successfully invalidated
the Pfizer patent.
Following Mylan’s successful petitioning of the Court to enjoin FDA
approval of all competitors’ amlodipine applications after its March 23
launch of the product, the FDA announced on April 20th that because
Apotex invalidated the ‘303 patent, Apotex would be eligible to enter
the market once the mandate issued. The Agency did not indicate at that
time how the issuance of the mandate would affect the status of other
amlodipine applications. The issuance of the mandate came in concert
with the Court’s rejection of Pfizer’s petition for a rehearing and
rehearing en banc of its case with Apotex.
Apotex CEO Barry Sherman said, “While we are pleased that we are finally
able to enter the market with our generic Norvasc®, we continue to
believe this case screams out for reform of the generic drug approval
process. We disagree unequivocally with the decision of the FDA that
kept us off the market following our invalidation of the ‘303 patent. We
should have been able to immediately enter the market.”
“Moreover,” Sherman added “this case illustrates the perversity of a
generic drug approval system that prohibits the company that is the
first to successfully open the market to generic competition from
entering that market while allowing the company that lost its case to
reap huge rewards from a victory it did not achieve simply because it
was the first to file its application with the FDA. That makes no sense.
The system should allow the first company that wins in the courts to
enter the market irrespective of whether that company is the first to
file. Allowing the first to successfully defend the patent lawsuit to
enter the market immediately will benefit consumers by ensuring
subsequent filers have the appropriate incentive to continue the patent
fight – and thereby increase the chance of an earlier generic launch --
even though they might not have first to file status. Such a system
would also benefit consumers by bringing a swift and needed end to the
anti-consumer ‘bottleneck’ problem caused by anticompetitive patent
settlements between brand and generic pharmaceutical companies that
delay timely access to generic competition.”
“We have been advocating for such a change to policymakers in
Washington, DC and hope this example will help bring about the change in
the system that is so sorely needed,” Sherman added.
The Apotex Group manufactures more than 200 different high-quality
generic pharmaceuticals, used by millions of patients worldwide. Its
product line includes oral solids, liquids, injectables, nasal sprays,
ophthalmics, and inhalation solutions.
Norvasc® is a registered trademark of Pfizer, Inc.
Apotex
Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned
manufacturer of prescription drugs. Through its sales and marketing
headquarters in Weston, Florida and operations center in Indianapolis,
Apotex Corp. is committed to providing safe and affordable generic
medicines. Products manufactured and marketed by the Apotex Group are sold
in 115 countries around the world. For more information visit
www.apotexcorp.com.
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