SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Nov. 20, 2017 /PRNewswire/ -- UnitedTherapeutics Corporation (NASDAQ: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for Adcirca® (tadalafil) tablets through May 21, 2018, based on study
United Therapeutics markets and sells Adcirca for treatment of pulmonary arterial hypertension (PAH) in the United States under a license agreement with Lilly. A U.S. 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.
Under a previously-announced amendment to its license agreement with Lilly, effective December 1, 2017, United Therapeutics' royalty rate on net product sales of Adcirca will increase from five percent to ten percent, and the company will also be required to make milestone payments to Lilly equal to $325,000 for each $1,000,000 in net product sales.
Because the data submitted by Lilly to FDA does not include PAH patients, United Therapeutics does not anticipate any resulting expansion of the indication for Adcirca to include pediatric patients.
Adcirca is a phosphodiesterase 5 inhibitor (PDE5i) indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with New York Heart Association Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
Important Safety Information for Adcirca
WARNINGS AND PRECAUTIONS
For more information about Adcirca, please see the full prescribing information available at www.adcirca.com, or call 1-800-545-5979.
About United Therapeutics
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of innovative products to address the unmet medical needs of patients with chronic and life-threatening conditions. [uthr-g]
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding the timing of generic competition for Adcirca. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic and other reports filed with the Securities and Exchange Commission that could cause actual results to differ materially from anticipated results. Such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of November 20, 2017, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.
ADCIRCA is a registered trademark of Eli Lilly and Company.
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SOURCE United Therapeutics Corporation
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