Eagle Pharmaceuticals Wins Vasopressin Patent Trial

Rhea-AI Summary

Eagle Pharmaceuticals (NASDAQ: EGRX) has achieved a significant legal victory as the U.S. District Court for the District of Delaware ruled that its proposed vasopressin product does not infringe any patents asserted by Par. The ruling allows Eagle to continue its plans to market a generic version of Vasostrict, which generated $786 million in U.S. sales in 2020. CEO Scott Tarriff expressed optimism about providing a generic alternative, emphasizing its importance for public access. The court's decision does not address Eagle's claims regarding the invalidity of Par's patents.

Positive

• Court ruling favors Eagle, allowing its vasopressin product to proceed without patent infringement concerns.
• First to file an ANDA for a generic version of Vasostrict, a market valued at $786 million.
• Potential for improved public access to essential medication through the introduction of a generic alternative.

Negative

• None.

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that the U.S. District Court for the District of Delaware held that Eagle’s proposed vasopressin product does not infringe any of the patents Par asserted against the Company.

Eagle is first to file an Abbreviated New Drug Application (“ANDA”) referencing Vasostrict^®, which had total U.S. sales of $786 million in 2020. In May 2018, Par sued Eagle for infringement of several patents. The trial was held in July 2021. The Court heard Par’s argument as to why Eagle’s proposed product would infringe its patents, as well as Eagle’s arguments as to why Par’s patents are both invalid and unenforceable.

Today, the Court ruled that Par failed to meet its burden of proving that Eagle’s product would infringe any of the asserted patent claims. The opinion did not address Eagle’s invalidity or unenforceability claims.

“We are delighted with this decision,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals. “This is an important step toward giving the public a generic alternative to Vasostrict. We look forward to making our vasopressin product available soon.”

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include RYANODEX^®, BENDEKA^®, BELRAPZO^®, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle’s website at www.eagleus.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities law. Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “will,” “would,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, whether or not Par will appeal the court’s ruling or the outcome of any such appeal, statements regarding the Company’s ability to obtain and maintain regulatory approval of its products and product candidates, including vasopressin; the timing, progress and results of the Company’s clinical trials, including potential timing of commercial launch of vasopressin; and the ability of the Company’s product candidates, including vasopressin, to deliver value to stockholders. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the Company’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 and uncertainties include, but are not limited to: the impacts of the ongoing COVID-19 pandemic, including interruptions or other adverse effects on clinical trials and delays in regulatory review or further disruption or delay of any pending or future litigation; delay in or failure to obtain regulatory approval of the Company's product candidates and successful compliance with FDA, EMA and other governmental regulations applicable to product approvals; the outcome of litigation involving any of its products or that may have an impact on any of its products; the strength and enforceability of the Company’s intellectual property rights or the rights of third parties; the risks inherent in drug development and in conducting clinical trials; and those risks and uncertainties identified in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (the “SEC”) on March 5, 2021, as updated by the Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2021 and June 30, 2021, filed with the SEC on May 10, 2021 and August 9, 2021, respectively, and its other subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210831005804/en/

Investor Relations for Eagle Pharmaceuticals, Inc.:

Lisa M. Wilson

In-Site Communications, Inc.

T: 212-452-2793

E: lwilson@insitecony.com

Source: Eagle Pharmaceuticals, Inc.

FAQ

What recent court ruling did Eagle Pharmaceuticals receive regarding its vasopressin product?

Eagle Pharmaceuticals won a court ruling stating that its proposed vasopressin product does not infringe any patents asserted by Par.

What is the significance of the Vasostrict sales figure mentioned in the press release?

Vasostrict had total U.S. sales of $786 million in 2020, indicating a substantial market for Eagle's generic product.

How does the court ruling impact Eagle Pharmaceuticals' future plans?

The ruling allows Eagle to proceed with marketing its vasopressin product, crucial for providing a generic alternative to Vasostrict.

When did Par sue Eagle Pharmaceuticals for patent infringement?

Par sued Eagle in May 2018 regarding the infringement of several patents.

What did Eagle's CEO say about the court's decision?

CEO Scott Tarriff expressed delight with the decision, highlighting its importance for public access to a generic alternative.