DUBLIN, April 17, 2018 /CNW/ -- Endo International
plc (NASDAQ: ENDP) today announced that its subsidiaries, Par
Pharmaceutical, Inc. and Par Sterile Products, LLC, have received a
Notice Letter dated April 16, 2018
(the "Notice Letter") advising that Eagle Pharmaceuticals, Inc.
(Eagle) has submitted an Abbreviated New Drug Application (ANDA) to
the U.S. Food and Drug Administration (FDA) seeking approval from
the FDA to manufacture and market a generic version of
Vasostrict® (vasopressin injection, USP) 1 mL, in
the United States.
The Notice Letter also contains "Paragraph IV" certifications
alleging invalidity and non-infringement with respect to five
patents which Endo has listed in the FDA's Approved Drug
Products with Therapeutic Equivalence Evaluations, commonly known
as the Orange Book, for Vasostrict®. Endo
is assessing the details of the Notice Letter and formulating its
legal strategy. Endo intends to vigorously protect its
intellectual property, which may include initiating a patent
infringement lawsuit against Eagle within 45 days of receiving the
Notice Letter. If a lawsuit is filed within that timeframe,
it will trigger a stay of FDA approval of Eagle's generic version
of Vasostrict® for up to 30 months pursuant to the Hatch-Waxman
Act.
About Endo International plc
Endo International plc
(NASDAQ: ENDP) is a highly focused generics and specialty branded
pharmaceutical company delivering quality medicines to patients in
need through excellence in development, manufacturing and
commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in
Malvern, PA. Learn more at
www.endo.com.
Cautionary Note Regarding Forward-Looking
Statements
Certain information in this press release
contains certain "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995 and any
applicable Canadian securities legislation. Statements including
words such as "believes," "expects," "anticipates," "intends,"
"estimates," "plan," "will," "may," "look forward," "intend,"
"guidance," "future" or similar expressions are forward-looking
statements. All forward-looking statements in this press release
reflect Endo's current analysis of existing information
and represent Endo's judgment only as of the date of this
press release. We cannot predict the outcome of litigation.
If underlying assumptions prove inaccurate or unknown risks
or uncertainties materialize, actual results, including the outcome
of litigation, could vary materially
from Endo's expectations. Risks and uncertainties
include, among other things, general industry and market
conditions; technological advances and patents attained by
competitors; challenges inherent in the research and development
and regulatory processes, including regulatory decisions, product
recalls, withdrawals and other unusual items; challenges related to
product marketing, such as the unpredictability of market
acceptance for new products and/or the acceptance of new
indications for such products; inconsistency of treatment results
among patients; potential difficulties in manufacturing; settlement
discussions or other proceedings; general economic conditions; and
governmental laws and regulations affecting domestic and foreign
operations. Endo expressly disclaims any intent or obligation to
update these forward-looking statements except as required by law.
Additional information concerning these and other risk factors can
be found in Endo's periodic reports filed with the U.S. Securities
and Exchange Commission and in Canada on the System for Electronic Data
Analysis and Retrieval ("SEDAR"), including current reports on Form
8-K, quarterly reports on Form 10-Q and annual reports on Form
10-K.
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SOURCE Endo International plc