Mylan Settles Provigil® Litigation With Teva
PITTSBURGH, June 8, 2012
PITTSBURGH, June 8, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary Mylan Pharmaceuticals Inc. has resolved all
disputes with Teva Pharmaceuticals USA, Inc. stemming from litigation brought
by Mylan in federal court in the District of Columbia against the U.S. Food
and Drug Administration (FDA) concerning Mylan's abbreviated new drug
application (ANDA) for Modafinil Tablets, 100 mg and 200 mg. Modafinil Tablets
are the generic version of Cephalon's Provigil®, indicated to improve
wakefulness in adult patients with excessive sleepiness associated with
narcolepsy, obstructive sleep apnea and shift work disorder.
Pursuant to the terms of the agreement with Teva, Mylan is permitted to launch
its Modafinil Tablets, 100 mg and 200 mg, on August 10, 2012, which is prior
to the expiration of the 180-day marketing exclusivity period granted to Teva.
Other details of the settlement are confidential, and the agreement is subject
to review by the U.S. Department of Justice and the Federal Trade Commission.
Modafinil Tablets, 100 mg and 200 mg, had U.S. sales of $1.2 billion for the
12 months ending March 31, 2012, according to IMS Health.
This press release includes statements that constitute "forward-looking
statements," including with regard to the settlement of the 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: any legal or regulatory challenges to the settlement; strategies
by competitors or other third parties to delay or prevent product
introductions; 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 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 1,100 generic pharmaceuticals and several brand medications. In
addition, we offer a wide range of antiretroviral therapies, upon which
approximately one-third 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 150 countries and
territories. Our workforce of more than 18,000 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.
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