Indian pharmaceutical manufacturers Lupin, Unichem Laboratories and Alembic Pharmaceuticals said that they has received approval from the United States Food and Drug Administration to sell generic versions of Eli Lilly’s Cialis erectile dysfunction tablets, while rival Zydus Cadila said it has already begun selling the tablets on day 1.
The patent for Cialis, owned by Eli Lilly, ended in September 2018, but Indian generic manufacturers had to wait for another six months as they were not the first to file a generic application.
Teva Pharmaceuticals of the US was the first to file for a generic version of Cialis.
Tadalafil tablets are used to treat erectile dysfunction, benign prostatic hyperplasia and pulmonary arterial hypertension.
The drug, which competes with Viagra and others, will be sold in the doses of 2.5 mg, 5 mg, 10 mg and 20 mg.
As of December 2018, the drug had an annual sales of $1.78 billion in the US market.
Cialis is the second major erectile dysfunction drug to go generic, after Viagra. Generic versions of Viagra hit the market in late 2017, which had started impacting sales of branded Cialis as well.
Lupin is one of the world’s biggest makers of generic drugs, and sells both branded and generic formulations, biotechnology products and pharmaceutical ingredients globally. It is the world’s biggest manufacturer of anti-TB medicines and focuses on cardiovascular, diabetology, asthma, paediatric, CNS, GI, anti-infective and NSAID segments of the pharma market.
Headquartered in Mumbai, Unichem has operations in Roha in Maharashtra, Goa, Baddi in Himachal Pradesh, Pithampur in Uttar Pradesh, Ghaziabad and Sikkim. It is known for the sales of generic drugs across the world.
Alembic, headquartered in Vadodara, manufactures and markets generic pharmaceutical products all over the world. Established in 1907, it is also one of the leaders in branded generics in lndia, and has a marketing team of over 5,000 in its home market.
Ahmedabad -headquartered Zydus Cadila has manufacturing sites and research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim and even in the United States and Brazil.