Mylan N.V. has 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, for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older and maintenance of remission of ulcerative colitis in adults.
Mylan said on Thursday it believed it was 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.