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Eli Lilly Resolves Pending Patent Litigation for Best-Selling Cialis

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The pending patent litigation surrounded a unit dose patent for Cialis which was set to expire on April 26, 2020.

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July 14, 2017 | by Sarah Hand, M.Sc.

After going head-to-head with generic drugmakers in the US District Court for the Eastern District of Virginia, Eli Lilly has reached an agreement with the competitors regarding the impending patent expiration of its best-selling erectile dysfunction drug, Cialis (tadalafil). The pending patent litigation surrounded a unit dose patent for Cialis which was set to expire on April 26, 2020.

As part of the settlement agreement, Lilly’s market exclusivity for Cialis is expected to end on September 27, 2018, at the earliest. The agreement will delay the patent cliff for Lilly, but not for long.

“The unit dose patent for Cialis is valid and infringed by companies seeking to market a generic version of Cialis,” said Michael J. Harrington, senior vice president and general counsel for Lilly. “This is a royalty-bearing license agreement that provides us with more certainty regarding our US exclusivity. 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.”



Tadalafil, the active ingredient in Cialis, is also marketed at Adcirca which is indicated for the treatment of pulmonary arterial hypertension. Lilly expects the patent for this indication to expire as early as November 21, 2017, however that date could be extended to May 21, 2018 if the FDA approves the company’s application for exclusivity in the pediatric population.

In 2016, Cialis brought in $2.47 billion in sales for Lilly, representing over 10 percent of the company’s total annual revenue. The company is betting on newly-launched drugs – including type 2 diabetes drug Trulicity (dulaglutide), and Taltz (ixekizumab), a treatment for plaque psoriasis – to help them maintain annual growth through the loss of exclusivity for Cialis.

In 2014, reports surfaced that Lilly was looking into launching an over-the-counter (OTC) version of Cialis to help improve access to the drug and give the company a way to boost sales before patent expiry. Earlier this year, the British Medicines and Healthcare Products Regulatory Agency (MHRA) announced that they were considering making rival erectile dysfunction drug Viagra, available OTC in the UK.


Keywords:  Drug Patent, Generic, Market Exclusivity


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