Detailed Analysis of the Scope and Claims of United States Patent 10,064,875
Introduction
United States Patent 10,064,875, titled "Topical formulations comprising a steroid," is a significant patent in the field of dermatology, particularly for the treatment of skin diseases such as psoriasis, dermatoses, and other associated skin disorders. This patent, issued on September 4, 2018, is assigned to PROMIUS PHARMA LLC and involves the work of several inventors, including Udhumansha Ubaidulla, Sateesh Kandavilli, Ajay Sunil Vairale, Jeffrey A. Wayne, Vijendra Nalamothu, Meghal Mistry, and Refika Isil Pakunlu.
Scope of the Patent
The patent focuses on the development and application of topical formulations that contain at least one steroid. These formulations are designed for the topical administration of steroids in the form of sprays that are:
- Propellant-free: This means the sprays do not rely on gases like compressed air or liquefied gases to dispense the formulation.
- Substantially non-foaming: The formulations are designed to minimize foaming, which can be beneficial for patient comfort and ease of application.
- Alcohol-free: This is important for patients who may have sensitivities or preferences against alcohol-based products[2][4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Composition Claims: The patent claims cover the specific formulations of the topical sprays, including the types of steroids used (e.g., clobetasol propionate), the vehicle components (e.g., fatty acids, oils), and the absence of certain ingredients like propylene glycol and alcohol[2][4].
- Method Claims: These claims pertain to the processes for preparing the topical formulations and the methods of using them for treating skin diseases and disorders[2][4].
- Use Claims: The patent also claims the use of these formulations for managing specific skin conditions such as psoriasis, dermatoses, and other associated skin diseases or disorders[2][4].
Patent Landscape
Related Patents
The patent landscape surrounding US 10,064,875 includes several related patents that also focus on topical steroid formulations:
- US 10,588,914: Issued to ENCORE DERMATOLOGY, INC., this patent also deals with propellant-free, non-foaming, and alcohol-free topical steroid sprays for similar indications[2].
- US 9,855,334: Assigned to PROMIUS PHARMA LLC, this patent covers topical compositions comprising a corticosteroid and at least one penetration-enhancing agent, with the composition being substantially free of propylene glycol[2].
- US 9,956,231: Assigned to DR. REDDY'S LABORATORIES LTD., this patent also involves formulations for the topical administration of steroids in a similar manner[2].
Patent Expiration Dates
The patent US 10,064,875 is set to expire on August 31, 2030. This expiration date is consistent with other related patents, indicating a coordinated approach to intellectual property protection in this field[2].
Technological and Clinical Significance
Innovation in Formulations
The patent introduces innovative formulations that are more patient-friendly and effective. The absence of propellants, foaming agents, and alcohol makes these formulations more comfortable and less irritating for patients, which can improve adherence to treatment regimens[2][4].
Clinical Applications
These formulations are specifically designed for the management of skin diseases such as psoriasis, dermatoses, and other associated conditions. The use of steroids in a topical spray form can provide targeted treatment with minimal systemic side effects, which is a significant clinical advantage[2][4].
Commercial and Market Impact
Market Protection
The patent provides exclusive rights to PROMIUS PHARMA LLC to market and distribute these specific formulations until the patent expires in 2030. This exclusivity period allows the company to recoup its investment in research and development and to establish a market presence without immediate generic competition[2].
Generic Availability
As of now, there is no therapeutically equivalent generic version of these formulations available in the United States, which further solidifies the market position of the patent holder[2].
Patent Analytics and Claim Coverage
To fully understand the protection and opportunities provided by this patent, patent analytics tools can be utilized. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and potential future design opportunities. Claim charts generated by such tools can be reviewed by technical experts to determine the applicability of specific scope concepts to target products or methods[3].
Key Takeaways
- Innovative Formulations: The patent covers propellant-free, non-foaming, and alcohol-free topical steroid sprays.
- Clinical Applications: These formulations are designed for treating skin diseases like psoriasis and dermatoses.
- Patent Expiration: The patent is set to expire on August 31, 2030.
- Market Protection: The patent provides exclusive marketing rights to PROMIUS PHARMA LLC until expiration.
- Patent Landscape: Related patents cover similar formulations and applications.
FAQs
Q: What is the primary focus of United States Patent 10,064,875?
A: The primary focus is on the development and application of topical steroid formulations in the form of propellant-free, non-foaming, and alcohol-free sprays.
Q: Who are the inventors listed on this patent?
A: The inventors include Udhumansha Ubaidulla, Sateesh Kandavilli, Ajay Sunil Vairale, Jeffrey A. Wayne, Vijendra Nalamothu, Meghal Mistry, and Refika Isil Pakunlu.
Q: What are the clinical applications of these formulations?
A: These formulations are used for the management of skin diseases such as psoriasis, dermatoses, and other associated skin disorders.
Q: When is the patent set to expire?
A: The patent is set to expire on August 31, 2030.
Q: Is there a generic version of these formulations available?
A: No, there is currently no therapeutically equivalent generic version available in the United States.
Cited Sources
- United States Patent and Trademark Office - US10588914.pdf
- Drugs.com - Generic Impoyz Availability
- SLWIP - Patent Analytics
- Google Patents - US10064875B2 - Topical formulations comprising a steroid
- PharmaCompass - US Patent 10064875 | US Patents | Expiry | Expiration | Dates
