Pharma major Lupin Limited (Lupin) announced that it has received approval for its Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg.

Lupin’s Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg, is the generic equivalent of Eli Lilly and Company’s Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. It is indicated for the treatment of:

•Erectile dysfunction (ED)

•The signs and symptoms of benign prostatic hyperplasia (BPH)

•ED and the signs and symptoms of BPH (ED/BPH)

Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg (RLD: Cialis) had annual sales of approximately USD 1780 million in the US (IQVIA MAT December 2018).

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded &generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.