Mylan Comments on Favorable Ruling in Generic Celebrex® Patent Suit
PITTSBURGH, March 13, 2014
PITTSBURGH, March 13, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
confirmed that the United States District Court for the Eastern District of
Virginia has ruled invalid a patent, United States Patent No. RE44,048,
related to Pfizer's Celebrex® (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg
Mylan was sued by G.D. Searle LLC and Pfizer Asia Pacific PTE, Ltd. for
alleged infringementof this patent in connection with Mylan's Abbreviated New
Drug Application (ANDA) for its generic version of Celebrex.
Mylan expects to launch its generic version of Celebrex in May 2014, pending
final approval of its ANDA by the U.S. Food and Drug Administration
(FDA).Based on available information, Mylan believes it may be entitled to
180 days of shared generic market exclusivity on the 100 mg, 200 mgand 400 mg
strengths, subject to the FDA's determination that the product qualifies for
an award of exclusivity under the provisions of the Hatch-Waxman Act.
Celebrex® is indicated for the treatment of osteoarthritis, rheumatoid
arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain
and primary dysmenorrhea.For the 12 months ended December 31, 2013, Celebrex®
had total U.S. sales of approximately $2.2 billion.
This press release includes statements that constitute "forward-looking
statements," including with regard to litigation. These statements are made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Because such statements inherently involve risks and
uncertainties, actual future results may differ materially from those
expressed or implied by such forward-looking statements. Factors that could
cause or contribute to such differences include, but are not limited to:
strategies by competitors or other third parties to delay or prevent product
sales; risks inherent in legal and regulatory processes; and the other risks
detailed in the company's periodic filings with the Securities and Exchange
Commission. The company undertakes no obligation to update these statements
for revisions or changes after the date of this release.
Mylan is a global pharmaceutical company committed to setting new standards in
health care. Working together around the world to provide 7 billion people
access to high quality medicine, we innovate to satisfy unmet needs; make
reliability and service excellence a habit; do what's right, not what's easy;
and impact the future through passionate global leadership. We offer a growing
portfolio of more than 1,300 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral therapies,
upon which approximately 40% of HIV/AIDS patients in developing countries
depend. We also operate one of the largest active pharmaceutical ingredient
manufacturers and currently market products in approximately 140 countries and
territories. Our workforce of more than 20,000 people is dedicated to
improving the customer experience and increasing pharmaceutical access to
consumers around the world. But don't take our word for it. See for yourself.
See inside. mylan.com
SOURCE Mylan Inc.
Contact: Nina Devlin (Media) 724.514.1968 or Kris King (Investors)
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