PITTSBURGH, Nov. 25, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq:
MYL) today confirmed that it and several subsidiaries have been
sued by Baxter International, Inc., Baxter Healthcare Corporation
and Baxter Healthcare S.A., (collectively, "Baxter") in connection with the filing of an
Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug
Administration (FDA) for Esmolol HCl in Sodium Chloride Injection,
10mg/ml (250 ml) and 20 mg/ml (100 ml). This product is the generic
version of BREVIBLOC®, which is indicated for
supraventricular tachycardia or noncompensatory sinus tachycardia,
and intraoperative and postoperative tachycardia and/or
hypertension.
Mylan believes that its subsidiary Agila is the first company 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.
Baxter filed lawsuits against the
Mylan companies in the United States District Court for the
District of New Jersey and the
Northern District of West
Virginia.
For the 12 months ending Sept. 30,
2014, BREVIBLOC had U.S. sales of approximately $49 million, according to IMS Health.
Currently, Mylan has 287 ANDAs pending FDA approval representing
$111.6 billion in annual sales,
according to IMS Health. Forty-four of these pending ANDAs are
potential first-to-file opportunities, representing $29.5 billion in annual brand sales, for the 12
months ending June 30, 2014,
according to IMS Health.
This press release includes statements that constitute
"forward-looking statements," including with regard to 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 use of legal, regulatory, legislative or other
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. Learn more at mylan.com.
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SOURCE Mylan Inc.