Detailed Analysis of the Scope and Claims of United States Patent 10,792,246
Overview of the Patent
United States Patent 10,792,246, titled "Film Formulations Containing Dexmedetomidine and Methods of Producing Them," was granted on October 6, 2020, to Bio Xcel Therapeutics, Inc. and ARX, LLC. This patent is significant in the field of pharmaceuticals, particularly for the development and use of dexmedetomidine, a medication used for sedation during medical procedures and surgery[1][4].
Inventors and Applicants
The patent was invented by Vasukumar Kakumanu, David Christian Hanley, Frank Yocca, Chetan Dalpatbhai Lathia, and Scott David Barnhart. The applicants are Bio Xcel Therapeutics, Inc. and ARX, LLC, both based in the United States[1].
Patent Claims
The patent includes 26 claims that cover various aspects of the invention, including the composition of the film formulations, the methods of producing these formulations, and the specific uses of these formulations.
Composition of Film Formulations
The patent describes self-supporting, dissolvable films that contain dexmedetomidine or a pharmaceutically acceptable salt thereof. These films are designed for oral administration, providing transmucosal delivery of the active agent. The composition includes dexmedetomidine, a polymer matrix, and other excipients to enhance stability and delivery[1][5].
Methods of Production
The claims also cover the methods for producing these film formulations, including the steps involved in preparing the polymer matrix, incorporating dexmedetomidine, and forming the self-supporting films. These methods ensure the uniform distribution of the active ingredient and the stability of the film[1].
Specific Uses
The patent specifies the use of these film formulations for treating various conditions, particularly agitation. The transmucosal delivery method allows for rapid onset of action and improved patient compliance compared to traditional routes of administration[1][5].
Mechanism of Action
Dexmedetomidine, the active ingredient in these formulations, is an alpha-2A adrenergic receptor agonist. It decreases sympathetic tone, attenuating neuroendocrine and hemodynamic responses to stress, which is crucial for its sedative effects during medical procedures and surgery[4].
Patent Landscape
Current Status and Expiration
The patent, US 10,792,246, is one of several patents protecting the drug Igalmi, owned by Bio Xcel Therapeutics, Inc. The patent is set to expire on June 26, 2039. However, the generic launch of Igalmi is delayed due to additional exclusivities granted by the FDA, which run concurrently with the patent protection[2][5].
Related Patents and Exclusivities
Igalmi is protected by a total of 11 US drug patents filed from 2022 to 2024, none of which have expired yet. These patents, along with FDA-granted exclusivities, ensure that no generic or bioequivalent version of Igalmi can be marketed until at least January 12, 2043[2][5].
Global Context
The patent landscape for AI-driven drug discovery and pharmaceutical formulations is highly competitive and evolving. The United States leads in the number of patents in this field, followed by China and Europe. This trend indicates significant investment and innovation in drug discovery and formulation technologies[3].
Industry Impact
Market Dominance
The exclusive rights granted by this patent and others like it allow Bio Xcel Therapeutics, Inc. to maintain market dominance for Igalmi. This exclusivity period is crucial for the company to recoup its investment in research and development and to generate revenue without immediate generic competition[2][5].
Innovation and Competition
The patent landscape in pharmaceuticals, particularly for drugs like Igalmi, encourages continuous innovation. New entrants and established players are continually contributing to the development of new formulations and delivery methods, driving advancements in patient care and treatment options[3].
Key Takeaways
- Patent Scope: The patent covers film formulations containing dexmedetomidine, methods of production, and specific uses for treating agitation.
- Expiration: The patent is set to expire on June 26, 2039, but generic launch is delayed due to FDA exclusivities.
- Market Impact: The patent ensures market exclusivity for Igalmi, allowing Bio Xcel Therapeutics, Inc. to maintain market dominance.
- Innovation: The competitive patent landscape drives innovation in pharmaceutical formulations and delivery methods.
FAQs
What is the primary use of the film formulations described in US Patent 10,792,246?
The primary use is for the treatment of agitation, particularly through transmucosal delivery of dexmedetomidine.
Who are the inventors and applicants of US Patent 10,792,246?
The inventors are Vasukumar Kakumanu, David Christian Hanley, Frank Yocca, Chetan Dalpatbhai Lathia, and Scott David Barnhart. The applicants are Bio Xcel Therapeutics, Inc. and ARX, LLC.
What is the mechanism of action of dexmedetomidine?
Dexmedetomidine is an alpha-2A adrenergic receptor agonist that decreases sympathetic tone and attenuates neuroendocrine and hemodynamic responses to stress.
When is the patent set to expire?
The patent is set to expire on June 26, 2039.
Why is the generic launch of Igalmi delayed despite the patent expiration date?
The generic launch is delayed due to additional FDA-granted exclusivities that run concurrently with the patent protection, extending the exclusivity period until at least January 12, 2043.
Sources
- United States Patent and Trademark Office - Film Formulations Containing Dexmedetomidine and Methods of Producing Them[1].
- Pharsight - GreyB - Igalmi patent expiration[2].
- ResearchAndMarkets.com - AI Driven Drug Discovery Patent Landscape Report 2024[3].
- DrugBank - Dexmedetomidine: Uses, Interactions, Mechanism of Action[4].
- Drugs.com - Generic Igalmi Availability[5].
