Federal Circuit Rules in Favor of Eagle Pharmaceuticals in Vasopressin Litigation
August 18 2022 - 12:53PM
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced that the U.S. Court of Appeals for the
Federal Circuit affirmed the U.S. District Court for the District
of Delaware’s decision that Eagle’s vasopressin product does not
infringe on any of the patents asserted by Par Pharmaceutical, Inc.
(“Par”).
Par previously sued Eagle in 2018, alleging infringement of
several of its patents and a trial was held in July 2021. The
District Court held that Eagle did not infringe on any of Par’s
patents, and Par appealed. Oral arguments were held before the
Federal Circuit in July 2022. Today, the Federal Circuit issued its
decision rejecting Par’s arguments and affirming the District
Court’s finding of non-infringement.
Eagle was the first to file an Abbreviated New Drug Application
(“ANDA”) referencing Vasostrict®. On December 15, 2021, the U.S.
Food and Drug Administration (“FDA”) approved Eagle’s ANDA for
vasopressin, a product that is indicated for use to increase blood
pressure in adults with vasodilatory shock (e.g., post-cardiotomy
or sepsis) who remain hypotensive despite fluids and
catecholamines. Eagle commenced marketing its product in January
2022.
Kirkland & Ellis LLP is counsel for Eagle.
About Eagle Pharmaceuticals, Inc.
Eagle is a fully integrated pharmaceutical company with research
and development, clinical, manufacturing and commercial expertise.
Eagle is committed to developing innovative medicines that result
in meaningful improvements in patients’ lives. Eagle’s
commercialized products include vasopressin, PEMFEXY®, RYANODEX®,
BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and BYFAVO® and BARHEMSYS®
through its wholly owned subsidiary Acacia Pharma Inc. Eagle’s
oncology and CNS/metabolic critical care pipeline includes product
candidates with the potential to address underserved therapeutic
areas across multiple disease states. Additional information is
available on Eagle’s website at www.eagleus.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, and other securities law. Forward-looking
statements are statements that are not historical facts. Words and
phrases such as “anticipated,” “forward,” “will,” “would,” “may,”
“remain,” “potential,” “prepare,” “expected,” “believe,” “plan,”
“near future,” “belief,” “guidance,” and similar expressions are
intended to identify forward-looking statements. These statements
include, but are not limited to, the Company’s ability to obtain
and maintain regulatory approval of its products and product
candidates, including the ANDA for vasopressin; the outcome of any
potential appeal of the ruling in the vasopressin matter; the
timing and progress of the Company’s launch of vasopressin; the
ability of the Company to successfully commercialize vasopressin;
the ability of vasopressin to benefit providers and patients as an
alternative to Vasostrict; the period of marketing exclusivity for
vasopressin; and the ability of the Company’s product candidates,
including vasopressin, to deliver value to stockholders. All of
such statements are subject to certain risks and uncertainties,
many of which are difficult to predict and generally beyond the
Company’s control, that could cause actual results to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. Such risks and
uncertainties include, but are not limited to: the impacts of the
ongoing COVID-19 pandemic, including interruptions or other adverse
effects on clinical trials and delays in regulatory review or
further disruption or delay of any pending or future litigation;
delay in or failure to obtain regulatory approval of the Company's
product candidates and successful compliance with FDA, European
Medicines Agency and other governmental regulations applicable to
product approvals; the outcome of litigation involving any of its
products or that may have an impact on any of its products; the
strength and enforceability of the Company’s intellectual property
rights or the rights of third parties; the risks inherent in drug
development and in conducting clinical trials; and those risks and
uncertainties identified in the “Risk Factors” sections of the
Company's Annual Report on Form 10-K for the year ended December
31, 2021, filed with the Securities and Exchange Commission (the
“SEC”) on March 8, 2022, the Company’s Quarterly Report on Form
10-Q for the quarter ended March 31, 2022, filed with the SEC on
May 9, 2022, and its other subsequent filings with the SEC,
including the Company’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2022, which the Company expects to file with
the SEC on August 9, 2022. Readers are cautioned not to place undue
reliance on these forward-looking statements. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Except to the extent required by law,
the Company undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made.
Investor Relations for Eagle Pharmaceuticals,
Inc.:
Lisa M. WilsonIn-Site Communications, Inc. T: 212-452-2793 E:
lwilson@insitecony.com
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