Eagle Pharmaceuticals Receives Sixth Patent for Bendamustine

-Six Orange Book Listed Patents Running from 2026-2033-

Tuesday, February 23, 2016 7:19 am EST

Dateline:

WOODCLIFF LAKE, N.J.

Public Company Information:

NASDAQ:
EGRX

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) (“Eagle” or the “Company”) today announced that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 9,265,831, which pertains to liquid bendamustine hydrochloride (HCl) formulations. The patent issued today expires on January 28, 2031. This new patent, along with five previously issued Patents (Nos. 8,609,707, 8,791,270*PED, 9,000,021, 9,034,908, and 9,144,568), further expands and protects Eagle’s bendamustine HCI intellectual property estate. This grant brings the total number of Orange Book listed patents to six, with this latest patent to be included shortly.

“Eagle continues to strengthen its bendamustine patent portfolio with now six Orange Book listed patents running from 2026-2033 and several more pending. The issuance of this new patent supports the long-term earnings potential of the bendamustine franchise products and further protects its longevity. Given the nature of our patent portfolio, the Company believes that it will be very difficult for any ANDA filers to design around these patents,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Under a February 2015 exclusive license agreement for BENDEKA™ (bendamustine hydrochloride) Injection, Teva Pharmaceuticals is responsible for all U.S. commercial activities for the product including promotion and distribution.

The following table lists the patents for liquid bendamustine hydrochloride (HCl) formulations:

         
U.S. Patent No.       Patent Expiration
8,609,707       8/11/2031

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
 

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,” “intends,” “anticipate(s),” “plan,” “enables,” “potentially,” “entitles,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events including, but not limited to: difficulties or delays in manufacturing; the enforceability or defense of intellectual property rights against third parties; the success of Eagle’s commercial relationship with Teva and the companies’ ability to successfully work together; the availability and pricing of third party sourced products and materials, and products licensed to third-parties for promotion and distribution; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; and other factors that are discussed in Eagle’s Annual Report on Form 10-K for the year ended September 30, 2014, 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 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.

Contact:

Investor Relations for Eagle Pharmaceuticals, Inc.:
In-Site Communications, Inc.
Lisa M. Wilson, 212-452-2793
lwilson@insitecony.com

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