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Amneal and Kashiv File First Xolair® (omalizumab) IPR

by Robert S. Schwartz, Ph.D.
May 28, 2026

On May 26, 2026, Amneal and Kashiv filed IPR2026-00260 challenging Genentech’s U.S. Patent No. 12,030,959, which claims methods for treating food allergies in pediatric patients using omalizumab.  The Petition challenges claims 1, 3, 5, 17-18 and 22-24 as anticipated and claims 1-29 as obvious over Patent Owner’s own prior-art disclosures, including the label for Xolair® (omalizumab) and Genentech’s OUtMATCH clinical trial protocol, in addition to third-party clinical trials.

Amneal and Kashiv announced the submission of an aBLA for ADL-018 (omalizumab), a proposed biosimilar to Xolair®, in September 2025 (previously reported Amneal / Kashiv Submit an aBLA for Xolair® (omalizumab) Proposed Biosimilar ADL-018).  This is the first IPR challenging a patent related to Xolair®.

Celltrion’s Omlyclo® (omalizumab-igec) was approved as the first interchangeable biosimilar to Xolair® in March 2025 (previously reported FDA Approves First Interchangeable Biosimilar of Xolair®: Celltrion’s Omlyclo® (omalizumab-igec)), and Teva’s aBLA for TEV-45779 (omalizumab) was accepted for review in March 2026 (previously reported FDA and EMA Accept Teva’s Omalizumab Biosimilar Applications).  There are no other pending patent disputes related to Xolair®.

Genentech reported 2025 U.S. sales of 3.075 billion CHF (approximately $3.92 billion USD) for Xolair®.

For more information on this and other biosimilar patent disputes, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.

 

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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