Mylan Inc 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 (first to file). The plaintiffs filed the lawsuit in the U.S. District Court for the District of New Jersey.
The details related to Mylan complaint can be read here
Sandoz is sued for following patents:U.S. Patent No. 8,217,083 (“the ‘083 patent”) and U. S. Patent No. 8,436,051
The detailed complaint against Sandoz can be reached here
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 (first to file). The plaintiffs filed the lawsuit in the U.S. District Court for the District of New Jersey.
The details related to Mylan complaint can be read here
Sandoz is sued for following patents:U.S. Patent No. 8,217,083 (“the ‘083 patent”) and U. S. Patent No. 8,436,051
The detailed complaint against Sandoz can be reached here