Market Overview

Eagle Pharmaceuticals Announces New Patent Issued for BENDEKA

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– BENDEKA protected by 16 patents running from 2026 through 2033 –

– Fifteen total Orange Book listed patents –

Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or "the Company")
today announced that an additional patent has been issued related to
BENDEKA® by the United States Patent and Trademark
Office (USPTO). Patent number 10,052,385 will expire March 2033. The
USPTO has now issued or allowed a total of 16 patents in the BENDEKA
family of patents expiring from 2026 to 2033.

The newly issued patent will be listed in the U.S. Food and Drug
Administration's (FDA) Approved Drug Products with Therapeutic
Equivalence Evaluations (Orange Book) bringing Eagle's total Orange Book
listed patents for BENDEKA to fourteen1. BENDEKA has Orphan
Drug Exclusivity (ODE) until December 2022 as a result of the U.S.
District Court for the District of Columbia's decision issued on June 8,
2018.

"The ODE and growing strength of our intellectual property portfolio may
protect the BENDEKA franchise well beyond 2022," stated Scott Tarriff,
Chief Executive Officer of Eagle Pharmaceuticals.

The following table lists issued patents for Eagle's liquid 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
9,579,384 3/15/2033
9,579,397 3/15/2033
9,579,398 3/15/2033
9,579,399 3/15/2033
10,010,533 1/28/2031
10,052,385 3/15/2033
1Orange Book patent 270 owned by Cephalon, Inc.
 

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,"
"continue," "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: Eagle's ability to defend against third party attempts to design
around or invalidate its patents; successful compliance with FDA and
other governmental regulations applicable to product approval,
manufacturing facilities, products and/or businesses; the FDA's ability
to approve any drug applications referencing BENDEKA prior to December
2022; the ability of generic TREANDA products to enter the market prior
to 2022; Eagle's market protection for BENDEKA; the commercial success
of Eagle's commercial portfolio, including BENDEKA; successful
compliance with FDA and other governmental regulations; 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, 2017, 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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