Detailed Analysis of the Scope and Claims of United States Patent 10,961,250
Introduction
United States Patent 10,961,250, titled "Short-acting benzodiazepine salts and their polymorphic forms," is a significant patent in the pharmaceutical industry, particularly in the realm of sedative and anxiolytic medications. This patent is held by PAION UK LIMITED and is associated with the drug remimazolam, marketed under the brand name Byfavo.
Patent Overview
Issuance and Expiration
The patent was issued on March 30, 2021, and is estimated to expire on July 10, 2027[5].
Inventors and Assignees
The inventors listed on this patent include Gary Stuart Tilbrook and Louisa Jane Quegan. The assignee is PAION UK LIMITED, a company involved in the development and commercialization of pharmaceuticals[5].
Scope of the Patent
Subject Matter
This patent pertains to the besylate salts of the compound remimazolam, a short-acting benzodiazepine. Remimazolam is used for the induction and maintenance of procedural sedation during short procedures[1].
Polymorphic Forms
The patent covers various polymorphic forms of remimazolam besylate. Polymorphism in pharmaceuticals refers to the ability of a compound to exist in multiple crystalline forms, which can affect the drug's solubility, stability, and bioavailability. The invention includes methods for preparing these polymorphic forms and their use as medicaments[5].
Claims
Composition of Matter Claims
The patent includes claims related to the composition of matter, specifically the besylate salts of remimazolam and their polymorphic forms. These claims are crucial as they define the proprietary chemical formulation that is protected under the patent[5].
Method of Preparation Claims
The patent also covers methods for preparing the besylate salts and their polymorphic forms. These method claims are important as they protect the specific processes developed by the inventors to produce the desired forms of the drug[5].
Use Claims
Claims related to the use of these salts and polymorphic forms as sedatives or hypnotics are also included. These use claims ensure that the patent holder has exclusive rights to market and use the drug for specific therapeutic purposes[5].
Patent Landscape
Related Patents
The patent landscape for remimazolam includes several other patents that cover different aspects of the drug, such as dosing regimens and combinations with other medications. For example, patents like US9827251 and US9561236 cover dosing regimens for sedation with remimazolam in combination with opioids like fentanyl[2][5].
Exclusivities and Patent Term
In addition to the patent protection, Byfavo (remimazolam) is also protected by FDA-granted exclusivities. These exclusivities prevent other companies from marketing generic or bioequivalent versions of the drug, even if the patents have expired. The generic launch date for Byfavo is estimated to be January 13, 2034, based on the patent and exclusivity landscape[2][5].
Impact on the Pharmaceutical Industry
Competitive Advantage
The patent and exclusivity protections provide PAION UK LIMITED with a significant competitive advantage in the market for short-acting benzodiazepines. This allows the company to maintain market exclusivity and protect its investment in the development of remimazolam[2][5].
Innovation and Development
The protection afforded by this patent encourages further innovation and development in the field of sedative medications. By securing exclusive rights to specific formulations and methods, companies are incentivized to invest in research and development of new and improved therapeutic agents[3].
Key Takeaways
- Patent Protection: United States Patent 10,961,250 protects the besylate salts and polymorphic forms of remimazolam, a short-acting benzodiazepine.
- Exclusivity: The patent, combined with FDA-granted exclusivities, ensures market exclusivity for PAION UK LIMITED until July 10, 2027, and prevents generic launch until January 13, 2034.
- Innovation: The patent landscape supports continued innovation in the development of sedative medications.
- Competitive Advantage: The exclusive rights provided by this patent give PAION UK LIMITED a significant competitive edge in the market.
FAQs
Q: What is the primary subject matter of United States Patent 10,961,250?
A: The primary subject matter is the besylate salts and their polymorphic forms of the short-acting benzodiazepine remimazolam.
Q: Who are the inventors and assignees of this patent?
A: The inventors are Gary Stuart Tilbrook and Louisa Jane Quegan, and the assignee is PAION UK LIMITED.
Q: What is the estimated expiration date of this patent?
A: The patent is estimated to expire on July 10, 2027.
Q: How does this patent impact the pharmaceutical industry?
A: It provides a competitive advantage to PAION UK LIMITED, encourages innovation, and protects the company's investment in remimazolam.
Q: What other protections besides the patent apply to Byfavo?
A: Byfavo is also protected by FDA-granted exclusivities that prevent generic or bioequivalent versions until January 13, 2034.
Cited Sources
- DrugBank: Remimazolam: Uses, Interactions, Mechanism of Action.
- Pharsight: Byfavo patent expiration.
- SLWIP: Patent Analytics.
- Google Patents: Short-acting benzodiazepine salts and their polymorphic forms.
- Drugs.com: Generic Byfavo Availability.
