SILVER SPRING, Md. and
RESEARCH TRIANGLE PARK, N.C.,
Feb. 15, 2018 /PRNewswire/
-- United Therapeutics Corporation (NASDAQ: UTHR) announced
today that it has entered into a Settlement Agreement with Actavis
Laboratories FL, Inc. ("Actavis") resolving ongoing litigation
concerning certain patents relating to United Therapeutics'
product, Orenitram® (treprostinil) Extended-Release
Tablets, and Actavis' Abbreviated New Drug Application ("ANDA")
seeking approval by the U.S. Food and Drug Administration to market
a generic version of Orenitram.
Under the Settlement Agreement, United Therapeutics granted to
Actavis a license to manufacture and commercialize the generic
version of Orenitram described in its ANDA filing in the United States beginning on June 15, 2027, although Actavis may be permitted
to enter the market earlier under certain circumstances.
The license included in the Settlement Agreement does not permit
Actavis to manufacture a generic version of any other United
Therapeutics product, such as Tyvaso® (treprostinil)
Inhalation Solution or Remodulin® (treprostinil)
Injection. The Settlement Agreement does not grant Actavis any
rights other than those required to launch Actavis' generic version
of Orenitram.
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 Actavis' 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
Orenitram. 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 February 15, 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.
ORENITRAM, REMODULIN and TYVASO are registered
trademarks of United Therapeutics Corporation.
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SOURCE United Therapeutics Corporation