BioXcel Therapeutics Announces USPTO’s Allowance of Patent Application for Method of Treating Agitation in Alzheimer’s Disease Using Oromucosal Formulations of Dexmedetomidine

Aligns with Company’s strategic focus on bringing to market BXCL501 for potential acute treatment of agitation for Alzheimer’s patients 

IGALMI market exclusivity further strengthened with receipt of issue notification for additional method of use patent (total of 8 U.S. patents, including 4 method of use patents) 

NEW HAVEN, Conn., Feb. 05, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that the United States Patent and Trademark Office (“USPTO”) has allowed U.S. Patent Application No. 17/496,470 with claims pertaining to a method of treating agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form. The broad claims encompass film formulations such as BXCL501 (sublingual dexmedetomidine), tablets, or wafers. The patent, when issued, is expected to have an expiration date of Dec. 29, 2037, subject to patent term adjustment (“PTA”), patent term extension (“PTE”), and terminal disclaimers.

The Company also announced that it has received an issue notification from the USPTO for U.S. Patent Application No. 17/993,422, from which U.S. Patent No. 11,890,272 (the “272 patent”) is expected to issue on Tuesday, Feb. 6, 2024. The ‘272 patent claims a method of treating agitation associated with schizophrenia or bipolar disorder through oromucosal administration of about 120 mcg to about 180 mcg of dexmedetomidine where the patient has a QT interval of less than 470 msec. This patent, when issued, is expected to have an expiration date of July 17, 2040, subject to PTA, PTE, and terminal disclaimers. It will be submitted for listing in the United States Food and Drug Administration's (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the "Orange Book") in addition to the seven currently listed U.S. patents for IGALMI (dexmedetomidine) sublingual film. Collectively, these eight patents will in general extend patent protection for IGALMI until Jan. 12, 2043.