WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--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 10,010,533 will expire January 2031. The USPTO has now issued or allowed a total of 15 patents in the BENDEKA family of patents expiring from 2026 to 2033.
The newly issued patent will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) bringing Eagle’s total Orange Book listed patents for BENDEKA to thirteen1. Furthermore, as a result of a Court decision issued on June 8, 2018, BENDEKA now has Orphan Drug Exclusivity (ODE). The FDA will not be able to approve any drug applications referencing BENDEKA until the ODE expires in December 2022. Moreover, the Company now does not expect generic TREANDA® entrants into the market until December 2022, rather than November 2019.
“We believe that with the recent positive ODE decision and the strength of our intellectual property portfolio, BENDEKA has longevity 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.
(owned by Teva Pharmaceutical Industries Ltd.)
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.
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.
1 Orange Book patent 270 owned by Cephalon, Inc.