Vanda Pharmaceuticals Provides an Update to HETLIOZ® ANDA Litigation Appeal: Federal Circuit grants motion to temporarily enjoin generic launch

Rhea-AI Summary

Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced an update regarding its appeal in the HETLIOZ® ANDA litigation. The company appealed a ruling from December 13, 2022, by the United States District Court for Delaware to the Federal Circuit. A temporary injunction has been granted, preventing Teva Pharmaceuticals and Apotex from entering the market until at least January 6, 2023. Vanda seeks to extend this injunction while the appeal is considered, critical for protecting its HETLIOZ® market position.

Positive

• Temporary injunction granted against Teva and Apotex protects HETLIOZ® market until at least January 6, 2023.
• Vanda's appeal process indicates an ongoing commitment to defending its product against generic competition.

Negative

• Ongoing litigation may result in prolonged uncertainty affecting investor confidence.
• Potential revenue loss if the appeal does not succeed and Teva and Apotex enter the market.

WASHINGTON, Dec. 16, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provided an update on its appeal of the recent HETLIOZ^® ANDA litigation ruling.

On December 14, 2022, Vanda appealed the December 13^th decision of the United States District Court for the District of Delaware in the HETLIOZ^® ANDA litigation to the United States Court of Appeals for the Federal Circuit and requested an injunction prohibiting market entry by Teva Pharmaceuticals USA, Inc. (Teva) and Apotex Inc. (Apotex) while the appeal is pending. Today, the Court granted a temporary injunction to prohibit market entry by Teva and Apotex until at least January 6, 2023 while the Court considers Vanda's pending motion for an injunction that would extend until the Court decides the appeal. 

About Vanda Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on Twitter @vandapharma.

About HETLIOZ^®

For full U.S. Prescribing Information for HETLIOZ^® and HETLIOZ LQ^®, including indication and Important Safety Information, visit www.hetlioz.com.

Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer 
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com

Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com 

View original content:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-provides-an-update-to-hetlioz-anda-litigation-appeal-federal-circuit-grants-motion-to-temporarily-enjoin-generic-launch-301705454.html

SOURCE Vanda Pharmaceuticals Inc.

FAQ

What is the latest update on Vanda Pharmaceuticals' HETLIOZ® ANDA litigation?

Vanda Pharmaceuticals has appealed the December 13, 2022 ruling related to HETLIOZ® ANDA litigation and was granted a temporary injunction against Teva and Apotex.

When is the court's decision regarding the HETLIOZ® appeal expected?

The court has temporarily prohibited market entry by Teva and Apotex until at least January 6, 2023, while considering Vanda's motion.

How does the HETLIOZ® litigation impact Vanda Pharmaceuticals' stock?

The outcome of the litigation may significantly affect Vanda's market position and revenue, impacting investor sentiment.