Mylan Inc. MYL today
confirmed that it and its subsidiary Mylan Pharmaceuticals have been sued by
Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx
Pharmaceuticals Inc., in connection with the filing of an Abbreviated New Drug
Application (ANDA) with the U.S. Food and Drug Administration (FDA) for
Sorafenib Tablets, 200 mg. This product is the generic version of NEXAVAR^®,
which is indicated for the treatment of certain types of cancers including
unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
Mylan believes that it 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. The plaintiffs filed suit against the Mylan companies in
the United States District Court in the District of Delaware.
For the 12 months ending Dec. 31, 2014, NEXAVAR had U.S. sales of
approximately $48 million, according to IMS Health.
Currently, Mylan has 283 ANDAs pending FDA approval representing $107.1
billion in annual sales, according to IMS Health. Forty-three of these pending
ANDAs are potential first-to-file opportunities, representing $27.2 billion in
annual brand sales, for the 12 months ending June 30, 2014, according to IMS
Health.
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 25,000 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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