HERTFORDSHIRE, England and
PITTSBURGH, Nov. 19, 2015 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today confirmed that its subsidiaries Mylan
Pharmaceuticals Inc., Mylan Laboratories Limited and Mylan Inc.,
have been sued by Warner Chilcott
(US), LLC, Warner Chilcott Company, LLC and Qualicaps Co. Ltd. in
connection with the filing of an Abbreviated New Drug Application
(ANDA) with the U.S. Food and Drug Administration (FDA) for
Mesalamine Delayed-release Capsules, 400 mg. This product is the
generic version of DELZICOL®, which is indicated for the
(1) treatment of mildly to moderately active ulcerative colitis in
patients 5 years of age and older and (2) maintenance of remission
of ulcerative colitis in adults.
Mylan believes it is the first or 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 Eastern District of Texas.
For the 12 months ending Sept. 30,
2015, DELZICOL had U.S. sales of approximately $180 million, according to IMS Health.
Currently, Mylan has 253 ANDAs pending FDA approval representing
$100.8 billion in annual brand sales,
according to IMS Health. Fifty of these pending ANDAs are potential
first-to-file opportunities, representing $36.1 billion in annual brand sales, for the 12
months ending June 30, 2015,
according to IMS Health.
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 nearly 50% 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.
This press release includes statements that constitute
"forward-looking statements," including with regard to Mylan's
belief that it is one of the first companies to have filed a
substantially complete ANDA containing a Paragraph IV certification
for the product and that it expects to be eligible for 180 days of
marketing exclusivity in the U.S. upon final FDA approval 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 our introduction of new products;
actions taken by regulatory and governmental agencies with respect
to our or our competitors' current or future products; success of
clinical trials and our ability to execute on new product
opportunities; other risks inherent in legal and regulatory
processes, uncertainties and 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.
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visit:http://www.prnewswire.com/news-releases/mylan-confirms-first-to-file-patent-challenge-relating-to-delzicol-300182148.html
SOURCE Mylan N.V.