www.fdanews.com/articles/182645-lilly-settles-cialis-patent-case-delaying-generic-competition-through-september-2018
Lilly Settles Cialis Patent Case, Delaying Generic Competition Through September 2018
July 14, 2017
Eli Lilly & Co. settled with several generic companies to resolve pending litigation over a unit dose patent for Cialis (tadalafil), delaying potential ANDA competition.
Under the royalty-bearing license agreement, Cialis exclusivity is now expected to end Sept. 27, 2018 at the earliest. The patent had been set to expire in April 2020.
The company said there will be no change to the company’s 2017 financial expectations through the remainder of the decade as a result of the settlement. Lilly’s general counsel, Michael Harrington, said the agreement will provide more certainty regarding Cialis’ U.S. exclusivity.