POTTERS BAR, England and
PITTSBURGH, May 5, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq:
MYL) today confirmed that it and its subsidiaries Mylan
Pharmaceuticals Inc. and Mylan Technologies Inc. have been sued by
Noven Pharmaceuticals Inc. and Hisamitsu Pharmaceutical Co., Inc.,
in connection with the filing of an Abbreviated New Drug
Application (ANDA) with the U.S. Food and Drug Administration (FDA)
for Estradiol Transdermal System, USP, "Twice-Weekly" 0.0375
mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day. This product is
the generic version of Minivelle®, which is indicated
for the treatment of moderate to severe vasomotor symptoms due to
menopause and the prevention of postmenopausal osteoporosis.
Mylan CEO Heather Bresch
commented: "Our ANDA for a generic Minivelle is one of six Mylan
applications for transdermal products pending FDA approval,
representing $3.6 billion in annual
sales. Mylan currently markets seven transdermal product families
in the U.S., of which three form part of our women's health
portfolio, and we look forward to continue expanding access to high
quality medicines for patients in this space."
Mylan believes that it is the first company, or among 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 receiving final
FDA approval. The plaintiffs filed suit against the Mylan companies
in the United States District Court in the District of Delaware.
For the 12 months ending February
2015, Minivelle had U.S. sales of approximately $115 million, according to IMS Health.
Currently, Mylan has 273 ANDAs pending FDA approval representing
$106.9 billion in annual sales,
according to IMS Health. Forty-seven of these pending ANDAs are
potential first-to-file opportunities, representing $31.1 billion in annual brand sales, for the 12
months ending December 31, 2014,
according to IMS Health.
This press release includes statements that constitute
"forward-looking statements," including with regard to product
approvals, the expected first-to-file status, pending litigation,
and marketing 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: the impacts of
competition; changes in economic and financial conditions of the
company's business; strategies by competitors or other third
parties to delay or prevent product introductions; risks inherent
in legal and regulatory processes; uncertainties and other matters
beyond the control of management; 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 healthcare. 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 around 1,400 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 about 145 countries and territories. Our workforce of
approximately 30,000 people is dedicated to creating better health
for a better world, one person at a time. Learn more at
mylan.com.
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SOURCE Mylan N.V.