Mylan has 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.