Mylan Announces Ortho Tri-Cyclen Lo® Settlement Agreement
PITTSBURGH, Nov. 8, 2012
PITTSBURGH, Nov. 8, 2012 /PRNewswire/ --Mylan Inc. (Nasdaq: MYL) today
announced that it, along with Famy Care Ltd., has entered into a settlement
agreement with Janssen Pharmaceuticals Inc. that will resolve patent
litigation related to Norgestimate/Ethinyl Estradiol Tablets 0.180 mg/0.025
mg, 0.215 mg/0.025 mg and 0.250 mg/0.025 mg. Norgestimate/Ethinyl Estradiol
Tablets are the generic version of Janssen Pharmaceuticals Inc.'s Ortho
Tri-Cyclen Lo^® Tablets, which are indicated for the prevention of pregnancy
in women who elect to use oral contraceptives as a method of contraception.(1)
According to the terms of the settlement, Mylan will be licensed to sell its
Norgestimate/Ethinyl Estradiol Tablets 0.180 mg/0.025 mg, 0.215 mg/0.025 mg
and 0.250 mg/0.025 mg, on December 31, 2015, or earlier under certain
circumstances. Pursuant to the agreement, pending litigation will be
dismissed. All other terms and conditions of the settlement are confidential,
and the agreement itself is subject to review by the U.S. Department of
Justice and the Federal Trade Commission.
Ortho Tri-Cyclen Lo Tablets had U.S. sales of $424.5 million for the 12 months
ending September 30, 2012, according to IMS Health.
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
This press release includes statements that constitute "forward-looking
statements," including with regard to the settlement of the litigation and
sales of the product. 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.
(1) Cigarette smoking increases the risk of serious cardiovascular side
effects from oral contraceptive use and this risk increases with age. Women
who use oral contraceptives should be advised to not smoke. Consult your
physician prior to beginning oral contraceptive use.
SOURCE Mylan Inc.
Contact: Nina Devlin (Media), +1-724-514-1968, or Kris King (Investors),
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