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FDAnews Drug Daily Bulletin

Clarus Grabs Three-Year Exclusivity for Jatenzo

Aug. 23, 2019

The FDA granted three-year market exclusivity to Clarus Therapeutics for its testosterone-replacement drug Jatenzo (testosterone undecanoate) — the first softgel oral testosterone and oral testosterone-ester approved by the agency.

Jatenzo is a prescription oral androgen used to treat adult men who have low or no testosterone due to certain medical conditions, such as hypogonadism.

Because of the agency’s decision, Jatenzo is shielded from new drug or generic competition until March 27, 2022.

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