Eli Lilly Resolves Patent Litigation Over Cialis

On July 12, 2017, Eli Lilly and Company announced it has entered into a settlement agreement with generic-drug companies over patent litigation in the US District Court for the Eastern District of Virginia regarding the Cialis (tadalafil) unit dose patent, which was previously set to expire on April 26, 2020. Cialis exclusivity will end on Sept. 27, 2018, at the earliest, as part of the agreement.

"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 license agreement that provides us with more certainty regarding our US exclusivity," said Michael J. Harrington, senior vice-president and general counsel for Lilly, in a press release. "Protection of intellectual property and the assurance of market exclusivity are extremely important to Lilly as we work to support the development of the next generation of innovative medicines."

The patent for Adcirca (tadalafil) is still expected to expire on Nov. 21, 2017, or on May 21, 2018, if FDA grants the company's application for pediatric exclusivity.