Eagle Pharmaceuticals Announces Fifth Orange Book Listed Patent for RYANODEX
Public Company Information:
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or “the Company”) today announced that the Company has been issued a new patent related to its RYANODEX® product (dantrolene sodium for injectable suspension) by the United States Patent and Trademark Office (USPTO). Patent number 9,884,044 will expire June 2022. The USPTO has now issued or allowed a total of seven patents in the RYANODEX family of patents expiring between 2022 and 2025. The newly issued patent will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
“We see significant value in RYANODEX and will continue to advance our work with multiple additional indications for which we believe RYANODEX could save lives. This additional patent enables us to fortify our patent estate surrounding RYANODEX so that we may protect the value of our dantrolene sodium portfolio for years to come,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
RYANODEX is approved and marketed for the treatment of malignant hyperthermia and for the prevention of malignant hyperthermia in patients at high risk. Eagle is currently investigating RYANODEX as a potential treatment of multiple additional indications including exertional heat stroke, MDMA and methamphetamine intoxication, and nerve agent exposure.
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.
RYANODEX® (dantrolene sodium) for injectable suspension is indicated for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.
Important Safety Information
RYANODEX® is associated with skeletal muscle weakness such as loss of grip strength and weakness in the legs, as well as drowsiness, dizziness, dysphagia, dyspnea, and decreased inspiratory capacity. Patients should not be permitted to ambulate without assistance until they have normal strength and balance. Care must be taken to prevent extravasation of RYANODEX® into the surrounding tissue due to the high pH of the reconstituted RYANODEX® suspension and potential for tissue necrosis.
RYANODEX full prescribing information can be found at www.RYANODEX.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 approval by the USPTO of Eagle’s patent applications covering dantrolene; Eagle’s ability to defend against third party attempts to design around or invalidate its patents covering dantrolene; 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.