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:
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,” “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.