PITTSBURGH, April 11, 2014 /PRNewswire/ -- Mylan Inc.
(Nasdaq: MYL) today confirmed that a federal district court has
granted its request to enforce a settlement agreement between Endo
Pharmaceuticals and Mylan settling patent litigation in connection
with Mylan's filing of an Abbreviated New Drug Application (ANDA)
with the U.S. Food and Drug Administration (FDA) for Frovatriptan
Succinate Tablets, 2.5 mg. This product is the generic version of
FROVA®, which is used to treat acute migraine headaches
in adults.
As a result of the decision, the Court has vacated its
January 28, 2014, decision in favor
of Endo regarding the parties' patent litigation over this product,
which could have prevented Mylan from launching its generic version
of FROVA until after the expiration of U.S. Patent 5,464,864 patent
on November 7, 2015. By enforcing the
settlement, Mylan can launch its product pursuant to the terms of
the settlement, contingent upon final FDA approval.
For the 12 months ending Dec. 31,
2013, Frovatriptan had U.S. sales of approximately
$66.41 million, according to IMS
Health.
Currently, Mylan has 187 ANDAs pending FDA approval representing
$94.9 billion in annual brand sales,
according to IMS Health. Forty-two of these pending ANDAs are
potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12
months ending Dec. 31, 2013,
according to IMS Health.
This press release includes statements that constitute
"forward-looking statements," including with regard to the
settlement of litigation and sales of products. 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 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.