Eagle Pharmaceuticals Announces New Patents Issued for Bendeka

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)– 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:

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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