Novel Therapeutic Applications of Ubrogepant
Legal Citation
Summary of the Inventive Concept
This inventive concept explores new therapeutic applications of ubrogepant beyond migraine treatment, leveraging its unique properties to address unmet needs in anxiety disorders, PTSD, IBS, fibromyalgia, and chronic fatigue syndrome.
Background and Problem Solved
The original patent disclosed ubrogepant's efficacy in treating migraine, but its potential extends beyond this indication. Current treatments for anxiety disorders, PTSD, IBS, fibromyalgia, and chronic fatigue syndrome are often inadequate, leading to significant unmet needs. This inventive concept addresses these limitations by applying ubrogepant to new therapeutic areas, providing innovative solutions for underserved patient populations.
Detailed Description of the Inventive Concept
The new claims describe novel therapeutic applications of ubrogepant, including its use in combination with cognitive-behavioral therapy for anxiety disorders, with exposure therapy for PTSD, in a pharmaceutical composition with a probiotic for IBS, in a transdermal delivery device for fibromyalgia, and in conjunction with graded exercise therapy for chronic fatigue syndrome. These applications capitalize on ubrogepant's unique mechanism of action, which modulates the activity of calcitonin gene-related peptide (CGRP) receptors, to provide improved treatment outcomes.
Novelty and Inventive Step
The new claims introduce a significant departure from the original patent's migraine-focused indication, demonstrating a non-obvious expansion of ubrogepant's therapeutic potential. The inventive concept's novelty lies in the unexpected application of ubrogepant to diverse disease areas, leveraging its CGRP receptor modulation properties to address previously unexplored therapeutic opportunities.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include different formulations, dosing regimens, or combinations of ubrogepant with other therapies. Variations could involve the use of ubrogepant analogs or derivatives, or its application in other disease areas, such as depression or substance abuse disorders.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential, as it addresses large, underserved markets with high unmet needs. The anxiety disorders market alone is projected to reach $15.4 billion by 2025, while the PTSD market is expected to grow to $12.6 billion by 2027. The inventive concept's broad applicability across multiple therapeutic areas positions it for substantial market penetration and revenue growth.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical therapeutics, specifically neurological and psychiatric treatment modalities with a focus on receptor-based pharmacological interventions
Person of Ordinary Skill (PHOSITA) Profile
A pharmacologist or clinical researcher with expertise in drug repurposing, receptor mechanism understanding, and knowledge of CGRP receptor interactions across multiple disease states
Obviousness Rationale
A skilled practitioner would recognize ubrogepant's CGRP receptor modulation mechanism as potentially applicable beyond migraine treatment. The source patent establishes ubrogepant's pharmacological profile, which inherently suggests broader therapeutic potential across neurological and inflammatory conditions. The PTD's proposed applications represent predictable extensions of the drug's known molecular mechanism.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,542 |
|---|---|
| Title | Treatment of migraine |
| Assignee(s) | Allergan Pharmaceuticals International Limited |