Assertio Therapeutics Announces Favorable NUCYNTA® Patent Ruling
March 28 2019 - 1:51PM
Assertio Therapeutics, Inc. (NASDAQ: ASRT) today announced that the
United States Court of Appeals for the Federal Circuit has ruled in
favor of Assertio with respect to the company’s patent litigation
against three filers of Abbreviated New Drug Applications (ANDAs)
for the NUCYNTA® franchise. The Federal Circuit’s ruling affirms
the decision of the United States District Court (D.N.J.), which
found U.S. patent No. 7,994,364 (the ‘364 Patent) to be valid and
infringed by the defendants. The ‘364 Patent covers the entire
NUCYNTA® franchise until December 2025.(1)
With the Court’s ruling, the company expects market exclusivity
until December 2025(1) for NUCYNTA® ER, NUCYNTA® and NUCYNTA® oral
solution (an unmarketed form of NUCYNTA). The NUCYNTA® franchise is
commercialized by Collegium Pharmaceutical, Inc. (Collegium). The
Company receives royalties from Collegium based on net sales of the
franchise. Based on Collegium’s current 2019 NUCYNTA franchise
revenue guidance, the Company currently expects such royalties to
be approximately $120 million in 2019.
The Federal Circuit affirmed the District Court’s ruling with
regard to U.S. patent No. 8,536,130 (the ‘130 Patent), which upheld
the validity of the ‘130 Patent but found that two of the three
ANDA filers do not infringe the patent. The ‘130 Patent covers
NUCYNTA® ER until March 2029.(1)
The defendants in the appeal of the District Court’s ruling in
the patent litigation included Alkem Laboratories Limited, Hikma
Pharmaceuticals International Limited and Actavis Elizabeth LLC,
along with certain of their affiliated companies. Gibson, Dunn
& Crutcher LLP represented Assertio in the litigation and
appeal.
(1) Patent expiration dates reflect the addition of six months
of pediatric patent term extension Assertio anticipates securing
from the United States Food and Drug Administration.
About Assertio Therapeutics, Inc.Assertio
Therapeutics is committed to providing responsible solutions to
advance patient care in the Company’s core areas of neurology,
orphan and specialty medicines. Assertio currently markets three
FDA-approved products and continues to identify, license and
develop new products that offer enhanced options for patients that
may be underserved by existing therapies. To learn more about
Assertio, visit www.assertiotx.com.
"Safe Harbor" Statement under the Private Securities
Litigation Reform Act of 1995This news release contains
forward-looking statements. These statements involve inherent risks
and uncertainties that could cause actual results to differ
materially from those projected or anticipated, including risks
related to regulatory approval and clinical development of
long-acting cosyntropin, expectations regarding royalties to be
received based on sales of NUCYNTA and NUCYNTA ER, expectations
regarding potential business opportunities and other risks outlined
in the Company's public filings with the Securities and Exchange
Commission, including the Company's most recent annual report on
Form 10-K and subsequent Quarterly Reports on Form 10-Q. All
information provided in this news release speaks as of the date
hereof. Except as otherwise required by law, the Company undertakes
no obligation to update or revise its forward-looking
statements.
Investor and Media Contact:John B. Thomas SVP,
Investor Relations and Corporate Communications
jthomas@assertiotx.com
Assertio (NASDAQ:ASRT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Assertio (NASDAQ:ASRT)
Historical Stock Chart
From Apr 2023 to Apr 2024