Additional six months regulatory exclusivity for Adcirca

20 November 2017

The US Food and Drug Administration has granted pediatric exclusivity for Adcirca (tadalafil) tablets through May 21, 2018, based on study results submitted by Eli Lilly (NYSE: LLY) in response to a written request by the FDA to investigate the use of tadalafil in pediatric patients with Duchenne muscular dystrophy.

US drugmaker United Therapeutics (Nasdaq: UTHR) markets and sells Adcirca for treatment of pulmonary arterial hypertension (PAH) in the USA under a license agreement with Lilly. A US patent for Adcirca will expire November 21, 2017, and FDA's decision provides an additional six months of regulatory exclusivity running from this date, providing an additional six months before FDA can approve a generic version of Adcirca.

News of the reprieve saw United Therapeutics’ share rise more than 3.2% to $127.00 by mid-morning today.

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