Eli Lilly settles Cialis patent litigation with generic makers
Eli Lilly has entered into a settlement agreement with generic companies Teva Pharmaceuticals and Watson Laboratories to resolve pending patent litigation over its drug Cialis (tadalafil).
Cialis is a treatment for patients with erectile dysfunction.
In 2016, Eli Lilly alleged Teva and Watson infringed a method of treatment patent involving the use of tadalafil after the companies filed Abbreviated New Drug Applications.
Eli Lilly said on Wednesday, July 12, that it will end its patent exclusivity in September 2018, at the earliest.
The patent covering Cialis was due to expire in April 2020 and litigation over the patent was pending at the US District Court for the Eastern District of Virginia.
Michael Harrington, senior vice president and general counsel for Eli Lilly, said in a statement: “The unit dose patent for Cialis is valid and infringed by companies seeking to market a generic version of Cialis.
“This is a royalty-bearing licence agreement that provides us with more certainty regarding our US exclusivity.”
Cialis is one of Eli Lilly’s best-selling drugs with sales of $2.47 billion last year.
In May, Eli Lilly was ordered to pay Germany-based company Erfindergemeinschaft UroPep $20 million after a court found that Cialis infringed a patent covering prostatic disease.
Two years after Cialis was approved to treat erectile dysfunction, in 2010 Eli Lilly filed a supplemental application proposing Cialis for the treatment of benign prostatic hyperplasia, an enlarged prostate gland. The supplemental application was approved in 2011.
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