Actavis plc announced on Wednesday that it has received approval from the FDA on its Abbreviated New Drug Application (ANDA) for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's Micardis.
As a "first applicant" to submit a substantially complete ANDA, Actavis is eligible for 180 days of generic market exclusivity. Actavis intends to launch the product immediately.
Micardis is an angiotensin II receptor blocker indicated for the treatment of hypertension, to lower blood pressure and cardiovascular risk reduction in patients unable to take ACE inhibitors. According to IMS Health data, for the 12 months ending September 30, 2013, Micardis had total U.S. sales of approximately $274 million.