The United States Food and Drug Administration has given Zydus Cadila approval to launch a generic version of the billion-dollar erectile dysfunction drug Cialis when patents expire.
The patents are expected to expire in September next year.
Cialis and Viagra are the most popular erectile dysfuntion drugs in the world. Cialis, created by Eli Lilly, was first approved in 2003, and has generated revenue of over $17 billion (Rs 1.1 lakh cr) for its maker.
The yearly sales of the branded drug is estimated at around $1.5 billion in the US alone.
The expiry of the patent has been closely awaited by Indian drug makers. Besides Zydus Cadila, Aurobindo, Teva Pharmaceuticals, Alembic, Watson Pharma and Sun Pharma have also got approval for generic versions of Cialis from the USFDA.
These approvals allow the companies to launch the generic version, called Tadalafil, as soon as patent protection expires.
Earlier this year, Eli Lilly said it had reached an agreement with generic majors to let the patents expire on September 27, 2018.
“This patent was set to expire on April 26, 2020. As part of the agreement, Cialis exclusivity is now expected to end at the earliest on September 27, 2018,” it said.
The settlement came after generic drug companies filed law suits regarding the company’s patent.
“Cialis exclusivity is now expected to end at the earliest on September 27, 2018,” the US drugmaker said.
“Patent expiration for Adcirca (tadalafil) is still expected on November 21, 2017, or on May 21, 2018, if the U.S. Food and Drug Administration grants the company’s application for pediatric exclusivity,” it added.