PITTSBURGH — Mylan on Tuesday confirmed that it, along with several subsidiaries, has been sued by Baxter International, Baxter Healthcare Corp. and Baxter Healthcare S.A. in relation to the filing of an abbreviated new drug application for esmolol HCl in sodium chloride injection (10-mg and 20-mg strengths), the generic version of Brevibloc. The drug is used to treat "supraventricular tachycardia or noncompensatory sinus tachycardia, and intraoperative and postoperative tachycardia and/or hypertension," according to Mylan.
Mylan says its subsidiary, Agila, is the first to file a "substantially complete" ANDA for the drug, granting it 180 days of marketing exclusivity upon receiving final approval from the Food and Drug Administration. Baxter filed suits against the companies in the U.S. District Court for the District of New Jersey, as well as the Northern District of West Virginia.
Brevibloc had sales in the United States of approximately $49 million, according to IMS Health data.