WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) (“Eagle” or “the Company”) today announced that three additional patents have been issued related to Bendeka by the United States Patent and Trademark Office (USPTO). Patent numbers 9,579,397 and 9,579,398 and 9,579,399 will expire March 2033. The USPTO has now issued or allowed a total of 14 patents in the Bendeka family of patents expiring from 2026 to 2033.
The three newly issued patents 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 thirteen. 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.
“We continue to build the strength of our intellectual property portfolio protecting Bendeka. We see significant value in Bendeka well beyond 2020,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
Several companies have unsuccessfully challenged one of the 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.
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: the impact, if any, that the appointment of a new director will have on Eagle’s business and strategy; the ability of this new director to leverage effectively his expertise and experience to expand Eagle’s reach and value; and other factors that are discussed in Eagle’s Annual Report on Form 10-K for the year ended December 31, 2016, 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.