Tadalafil - USA

July 12, 2017 -- Eli Lilly and Company has entered into a settlement agreement with generic companies to resolve pending patent litigation in the U.S. District Court for the Eastern District of Virginia regarding the Cialis® (tadalafil) unit dose patent (US 6,943,166). This patent was previously set to expire on April 26, 2020. As part of the agreement, Cialis exclusivity is now expected to end at the earliest on September 27, 2018. The parties have settled the case just before the bench trial which was set to begin on Jul 17, 2017. Many generic companies Actavis/Teva, Alembic, Aurobindo, Mylan, Sun, Zydus, Cipla, Accord, Apotex, Ajanta, Hetero & Dr. Reddy’s have challenged the OB listed patent(s).

"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 U.S. 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 November 21, 2017, or on May 21, 2018, if the U.S. Food and Drug Administration grants the company's application for pediatric exclusivity.