Lilly reaches settlement agreement in US Cialis patent litigation

Cialis exclusivity is now expected to end at the earliest on 27 September 2018.

Eli Lilly has entered into a settlement agreement with generic companies to resolve pending patent litigation in the US District Court for the Eastern District of Virginia regarding the Cialis (tadalafil) unit dose patent. This patent was previously set to expire on 26 April 2020. As part of the agreement, Cialis exclusivity is now expected to end at the earliest on 27 September 2018.

"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. "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."

Patent expiration for Adcirca (tadalafil) is still expected on 21 November 2017, or on 21 May 2018, if the FDA 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.