Eagle Pharmaceuticals Announces New Patents Issued for Bendeka
February 21 2017 - 9:34AM
Business Wire
-- Bendeka protected by 10 patents running from
2026 through 2033 –
-- Total of nine Orange Book listed patents
–
-- Additional four patents allowed --
Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) (“Eagle” or “the
Company”) today announced that four additional patents have been
issued related to Bendeka by the United States Patent and Trademark
Office (USPTO). Patent numbers 9,572,796 and 9,572,797 will expire
January 2031. Patent numbers 9,572,887 and 9,572,888 will expire
March 2033. The U.S. Patent and Trademark Office has allowed a
total of 14 patents in the Bendeka family of patents expiring from
2026 to 2033, four of which will issue over the next few
months.
Three of the newly issued patents will be listed in the FDA’s
Approved Drug Products with Therapeutic Equivalents Evaluations
(Orange-Book) bringing Eagle’s total Orange Book listed patents for
Bendeka to nine. Bendeka has also received Orphan Drug Designation
from the FDA. Eagle continues to pursue obtaining a grant of Orphan
Drug Exclusivity which would provide Bendeka exclusivity through
December 2022.
“Eagle has built an extensive intellectual property rights
portfolio for Bendeka, protecting the longevity of the franchise
for many years to come. With nine Orange-Book listed patents and
fourteen total allowed to date, we believe it will be very
difficult for any ANDA filers to design around these patents,”
stated Scott Tarriff, Chief Executive Officer of Eagle
Pharmaceuticals.
Several companies have unsuccessfully challenged one of these
Orange Book listed patents (U.S. Patent No. 8,791,270) in both
federal court and in the USPTO’s Patent Trial and Appeal Board
(PTAB). Both the U.S. District Court for the District of Delaware
and the PTAB have confirmed validity of the ‘270 patent which
expires in 2026. The other patents have previously not been
challenged.
The following table lists issued patents for liquid Eagle’s
bendamustine hydrochloride formulations:
U.S. PATENT NO.
PATENT EXPIRATION
8,609,707
1/28/2031
8,791,270*PED(owned by Teva Pharmaceutical Industries Ltd.)
7/12/2026
9,000,021 3/15/2033 9,034,908 3/15/2033 9,144,568 3/15/2033
9,265,831 1/28/2031 9,572,796 1/28/2031 9,572,797 1/28/2031
9,572,887 3/15/2033 9,572,888 3/15/2033
Under a February 2015 exclusive license agreement for BENDEKA,
Teva Pharmaceutical Industries, Ltd. is responsible for all U.S.
commercial activities for the product including promotion and
distribution.
About Eagle Pharmaceuticals, Inc.
Eagle is a specialty pharmaceutical company focused on
developing and commercializing injectable products that address the
shortcomings, as identified by physicians, pharmacists and other
stakeholders, of existing commercially successful injectable
products. Eagle’s strategy is to utilize the FDA's 505(b)(2)
regulatory pathway. Additional information is available on the
company’s website at www.eagleus.com.
Forward-Looking Statements
This press release contains forward-looking information within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended and other securities laws. Forward-looking
statements are statements that are not historical facts. Words such
as “will,” “may,”, “believe,” “intends,” “anticipate(s),” “plan,”
“enables,” “potentially,” “entitles,” and similar expressions are
intended to identify forward-looking statements. These statements
include statements regarding future events including, but not
limited to: the approval by the USPTO of Eagle’s patent
applications covering Bendeka; Eagle’s ability to defend against
third party attempts to design around or invalidate its patents
covering Bendeka; the timing and the outcome of any legal
proceedings involving Bendeka; the ability of Eagle to achieve
Orphan Drug Exclusivity for Bendeka; successful compliance with FDA
and other governmental regulations applicable to manufacturing
facilities, products and/or businesses; the ability of Eagle to
deliver sustained shareholder value over time; and other factors
that are discussed in Eagle’s Annual Report on Form 10-K for the
year ended December 31, 2015, and its other filings with the U.S.
Securities and Exchange Commission. All of such statements are
subject to certain risks and uncertainties, many of which are
difficult to predict and generally beyond Eagle’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 include, but are not limited
to whether Eagle’s management and/or board of directors will be
effective in managing Eagle’s business and future growth, as well
as the other risks described in Eagle’s filings with the U.S.
Securities and Exchange Commission. Readers are cautioned not to
place undue reliance on these forward-looking statements that speak
only as of the date hereof, and we do not undertake any obligation
to revise and disseminate forward-looking statements to reflect
events or circumstances after the date hereof, or to reflect the
occurrence of or non-occurrence of any events.
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version on businesswire.com: http://www.businesswire.com/news/home/20170221006005/en/
Investor Relations for Eagle Pharmaceuticals, Inc.:Lisa
M. Wilson, 212-452-2793lwilson@insitecony.com
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