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Generic Cialis: A Win for Teva and Eli Lilly’s Worst Nightmare

Generic Cialis: A Win for Teva and Eli Lilly’s Worst Nightmare

Teva has secured fist-to-file status for generic Cialis which will grant them 180 days of market exclusivity before other generic pharmaceutical companies have a chance to get their own versions approved.

Just a year after launching their generic version of Pfizer’s erectile dysfunction (ED) drug Viagra (sildenafil), Teva is taking on another blockbuster as they prepare to debut generic Cialis (tadalafil) in the US. Teva has secured fist-to-file status for generic Cialis which will grant them 180 days of market exclusivity before other generic pharmaceutical companies have a chance to get their own versions approved.

“We’re proud to offer an affordable treatment option for the estimated 30 million men affected by ED, many of whom will also have symptomatic [benign prostatic hyperplasia] which is estimated to affect 15 million men in the United States,” said Hafrun Fridriksdottir, Teva’s Executive Vice President and Head of Global R&D.

The company will be marketing four dosages (2.5 mg, 5 mg, 10 mg, 20 mg) in the country which will give patients the opportunity to access a generic substitution for their Cialis prescription. According to data from IQVIA, Cialis brought in close to 1.93 billion in US sales as of July of this year, offering Teva an opportunity to cash in on this lucrative market.

According to an article published in FiercePharma, sales of Eli Lilly’s Cialis took a hit in 2017 when generic Viagra – including Teva’s version – began hitting pharmacy shelves. Teva’s generic Cialis will almost certainly further erode sales, with some analysts saying annual sales could drop as low as $55 million in the next four years.

“This launch represents an important addition to our generics portfolio, building on our exclusive launch of a generic version of Viagra (sildenafil) tablets last year,” said Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva. “We’re committed to ensuring that patients are able to access this medicine.”

The launch is a major win for Teva, which has been facing financial troubles this year. Despite being one of the largest makers of generic pharmaceuticals in the world – with 550 FDA-approved generic products on the market in the US alone – the company has been planning some significant layoffs.

Late last year, Teva announced it would be cutting 25 percent of its workforce over the next two years in an effort to free-up $3 billion in capital. However, union workers at the company’s Jerusalem site successfully protested to force the company to postpone the layoffs until next year.