Mylan Inc. MYL today
confirmed that the company has been sued by Aptalis in connection with the
filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and
Drug Administration (FDA) for Mesalamine Rectal Suppositories, 1000 mg. This
product is the generic version of CANASA®.
Mylan 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 filed the
lawsuit in the U.S. District Court for the District of New Jersey.
For the 12 months ending March 31, 2013, CANASA^® had U.S. sales of
approximately $153 million, according to IMS Health.
Currently, Mylan has 173 ANDAs pending FDA approval representing $82.9 billion
in annual sales, according to IMS Health. Thirty-five of these pending ANDAs
are potential first-to-file opportunities, representing $22.6 billion in
annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS
Health.
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