PITTSBURGH, April 15, 2014 /PRNewswire/ -- Mylan Inc.
(Nasdaq: MYL) today confirmed that it and its partner Famy Care
Ltd. have entered into a settlement and license agreement with
Warner Chilcott Company, LLC, settling the parties' litigation in
connection with Mylan's filing of an Abbreviated New Drug
Application (ANDA) with the U.S. Food and Drug Administration (FDA)
for Norethindrone and Ethinyl Estradiol Chewable Tablets 0.8
mg/0.025 mg and Ferrous Fumarate Chewable Tablets. This product is
the generic version of Generess® Fe Tablets, which are indicated
for the prevention of pregnancy (1).
Under the terms of the settlement and license agreement, Mylan
may begin to sell a generic version of Generess Fe Tablets on
April 1, 2015, or earlier under
certain circumstances, and upon receiving final FDA approval.
Alternatively, Mylan will be permitted to launch an authorized
generic version of Actavis' product beginning on October 1, 2015. Pursuant to the agreement, the
parties pending litigation will be dismissed. All other terms and
conditions of the settlement and license agreement are
confidential, and the agreement itself is subject to review by the
U.S. Department of Justice and the Federal Trade Commission.
Mylan believes that its partner, Famy Care Ltd., is the first
company to have filed a substantially complete ANDA containing a
Paragraph IV certification with the U.S. FDA for Norethindrone and
Ethinyl Estradiol Chewable Tablets 0.8 mg/0.025 mg and Ferrous
Fumarate Chewable Tablets. For the 12 months ending Dec. 31, 2013, Generess Fe Tablets had U.S. sales
of approximately $81.83 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. When including ANDAs associated with
Mylan's recent acquisition of Agila, the company now has a total of
304 ANDAs pending FDA approval.
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
(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.