Lilly reaches settlement in Cialis patent litigation

Eli Lilly and Company said it entered a settlement agreement with generic drug companies to resolve pending patent litigation in the US District Court for the Eastern District of Virginia regarding the Cialis (tadalafil) unit dose patent.

Lilly said this patent was previously set to expire on April 26, 2020, but as part of the agreement, Cialis exclusivity is now expected to end at the earliest on September 27, 2018.

“The unit dose patent for Cialis is valid and infringed by companies seeking to market a generic version of Cialis,” said Lilly general counsel Michael Harrington.

“This is a royalty-bearing license agreement that provides us with more certainty regarding our U.S. exclusivity.”

Lilly said patent expiration for Adcirca (tadalafil) is still expected on November 21, 2017, or on May 21, 2018, if the US Food and Drug Administration grants the company’s application for pediatric exclusivity.

“There will be no change to the company’s 2017 financial guidance or mid-term expectations through the remainder of the decade as a result of this settlement,” said Lilly.