Mylan Confirms First-to-File Patent Challenge Relating to Uloric®

      Mylan Confirms First-to-File Patent Challenge Relating to Uloric®

-Expects to be eligible for 180 days of marketing exclusivity-

PR Newswire

PITTSBURGH, Nov. 1, 2013

PITTSBURGH, Nov. 1, 2013 /PRNewswire/ --Mylan Inc. (Nasdaq: MYL) today
confirmed that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has been
sued by Teijin Limited, Teijin Pharma Limited and Takeda Pharmaceuticals
U.S.A., Inc., in connection with the filing of an Abbreviated New Drug
Application (ANDA) with the U.S. Food and Drug Administration (FDA) for
Febuxostat Tablets, 40 mg and 80 mg. This product is the generic version of
Uloric®, which is indicated for the chronic management of hyperuricemia in
patients with gout. It is not recommended for the treatment of asymptomatic

Mylan believes it is one of the first companies to have filed a substantially
complete ANDA containing a Paragraph IV certification for this product and
expects to be eligible for 180 days of marketing exclusivity upon final FDA
approval. The plaintiffs have filed a lawsuit against Mylan in the United
States District Court for the District of Delaware.

For the 12 months ending June 30, 2013, Uloric had U.S. sales of approximately
$260.7 million, according to IMS Health.

Currently, Mylan has 179 ANDAs pending FDA approval representing $84.6 billion
in annual sales, according to IMS Health. Forty of these pending ANDAs are
potential first-to-file opportunities, representing $24.1 billion in annual
brand sales, for the 12 months ending June 30, 2013, according to IMS Health.

This press release includes statements that constitute "forward-looking
statements," including with regard to the expected first-to-file status and
pending 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: the use of legal, regulatory and
legislative 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

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 1,200 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.

SOURCE Mylan Inc.

Contact: Nina Devlin (Media), 724.514.1968, or Kris King (Investors),
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