SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C.,
Aug. 8, 2018 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) announced today
that it has entered into a Settlement Agreement with Watson Laboratories, Inc. ("Watson") resolving ongoing litigation concerning
certain patents relating to United Therapeutics' product, Tyvaso® (treprostinil) Inhalation Solution, and Watson's
Abbreviated New Drug Application ("ANDA") seeking approval by the U.S. Food and Drug Administration to market a generic version
of Tyvaso.
Under the Settlement Agreement, United Therapeutics granted to Watson a license under its patent rights to manufacture and
commercialize the generic version of Tyvaso described in its ANDA filing in the United States
beginning on January 1, 2026, although Watson may be permitted to enter the market earlier under
certain circumstances.
The license included in the Settlement Agreement does not permit Watson to manufacture a generic version of any other United
Therapeutics product, such as Remodulin® (treprostinil) Injection or Orenitram® (treprostinil)
Extended-Release Tablets. The Settlement Agreement does not grant Watson any rights other than those required to launch Watson's
generic version of Tyvaso.
In accordance with the Settlement Agreement, the parties will submit the Settlement Agreement to the U.S. Federal Trade
Commission and the U.S. Department of Justice for review and will also terminate the pending litigation concerning patents
relating to Watson's ANDA.
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]
Forward-looking Statements
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 potential launch of generic competition for Tyvaso. 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 August 8, 2018 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.
TYVASO is a registered trademark of United Therapeutics Corporation.
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SOURCE United Therapeutics Corporation