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Levitra, Cialis to Finally Go Off-Patent Later in 2018

Forked road with two signs pointing in opposite directions Generic Brand and Name Brand.

More generic options among the oral ED medications known as PDE5 inhibitors should arrive later this year.

Nearly two decades after the introduction of Viagra dramatically altered the face of erectile dysfunction treatment, generic formulations of the iconic blue pill became available in mid-December 2017. Additional generic alternatives are likely to come to market in America later this year when the U.S. patents on Cialis and Levitra are scheduled to expire.

It’s been a long wait, but men suffering from ED who have found the prices of the PDE5 inhibitors too high for them to afford will soon be able to get those same drugs at prices that are roughly 50 percent lower than the brand-name versions.

Cialis Patent Settlement 

Eli Lilly’s U.S. patent on Cialis had been expected to expire in November 2017, but the drugmaker successfully extended its market exclusivity on the popular ED drug by citing a unit-dose patent on Cialis that doesn’t expire until 2020. However, in a court-mediated patent settlement with a number of generic drugmakers anxious to market their versions of the drug, Lilly was able to hold off generic competition until September 27, 2018, at the earliest.

The patent settlement won Lilly nearly an additional year of U.S. patent exclusivity to maximize its revenues from Cialis, which chalked up nearly $1.5 billion in U.S. sales in 2016. That figure accounted for roughly 7 percent of Lilly’s worldwide revenues that year, according to an article posted at FiercePharma.com.

Unless Lilly has some additional cards up its sleeve, it is likely that the first generic formulations of Cialis — to be marketed as tadalafil, the drug’s active ingredient — will be available by the fourth quarter of 2018.

How Generic Drug Approval Process Works

Generic drugmakers hoping to market their formulations of a brand-name drug generally submit what are known as abbreviated new drug applications (ANDAs) to the Food and Drug Administration well in advance of the target drug’s patent expiration. Unlike the new drug application, or NDA, submitted to the drug regulatory agency on behalf of a new medication, the ANDA need not contain data from multiple rounds of clinical trials of the drug. It simply must satisfy the agency that the proposed generic version is bioequivalent to the brand-name drug for which it will be an alternative.

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The FDA has tentatively approved ANDAs on tadalafil from generic drugmakers Alembic, Aurobindo, Sun, Synthon, Teva, and Watson. This means that those companies will be free to market their generic versions of the drug when Lilly’s U.S. patent on Cialis expires.

Levitra Patent Expires in October

Levitra (vardenafil hydrochloride) is comarketed in the United States by Bayer HealthCare and GlaxoSmithKline. Its U.S. patent is scheduled to expire on October 31, 2018. It was the second PDE5 inhibitor to win FDA approval, coming to market in America in 2003. The FDA has given tentative approval to ANDAs on vardenafil from both Alembic and Teva.

In another case, a federal appeals court in November 2017 invalidated Bayer A.G.’s patent on Staxyn, an orosoluble (dissolves in the mouth) formulation of vardenafil hydrochloride. The patent challenge was brought by Teva, the world’s largest manufacturer of generic medications. Exactly when generic Staxyn will come to market is unclear.

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About Don Amerman

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Don Amerman has spent more than three decades in the business of writing and editing. During the last 15 years, his focus has been on freelance writing. For almost all of his writing, He has done all of his own research, both online and off, including telephone and face-to-face interviews where possible. Don Amerman on Google+