Details for Patent: 10,265,293

Which drugs does patent 10,265,293 protect, and when does it expire?

Patent 10,265,293 protects SYNDROS and is included in one NDA.

Summary for Patent: 10,265,293

Title:	Oral cannabinoid formulations
Abstract:	Oral cannabinoid formulations, including an aqueous-based oral dronabinol solution, that are stable at room or refrigerated temperatures and may possess improved in vivo absorption profiles with faster onset and lower inter-subject variability.
Inventor(s):	Goskonda; Venkat R. (Phoenix, AZ), Chavan; Ashok (Chandler, AZ), Kokate; Amit (Englewood, NJ), Gill; Howard (Scottsdale, AZ)
Assignee:	INSYS DEVELOPMENT COMPANY, INC. (Chandler, AZ)
Application Number:	15/132,896
Patent Claim Types: see list of patent claims	Formulation; Delivery;

United States Patent 10,265,293: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,265,293, titled "Oral Cannabinoid Formulations," is a significant patent in the pharmaceutical industry, particularly in the realm of cannabinoid-based medications. This patent, owned by Benuvia Operations LLC, is part of a broader portfolio of patents protecting oral and liquid cannabinoid formulations.

Background and Context

The patent in question is a continuation-in-part of earlier applications, highlighting the evolutionary nature of the research and development in this field. It builds upon previous patents and applications, such as US 13,644,283 and US 15,132,896, to improve and expand the formulations of oral cannabinoids[1][5].

Patent Scope and Claims

The scope of US 10,265,293 encompasses various aspects of oral cannabinoid formulations, including the composition, method of preparation, and delivery systems. Here are some key points:

Composition

The patent describes specific formulations of dronabinol, a synthetic cannabinoid, designed to enhance bioavailability and stability. These formulations often include excipients and solubilizing agents to improve the solubility of dronabinol in aqueous solutions, which is crucial for effective oral administration[1].

Method of Preparation

The patent details the methods for preparing these formulations, including the use of aqueous buffer solutions and specific solubilizing agents. These methods are designed to ensure consistent and reliable production of the formulations[1].

Delivery Systems

The patent also covers various delivery systems, such as oral solutions and capsules, which are designed to optimize the absorption and efficacy of the cannabinoid formulations[1].

Claims

The claims of the patent are comprehensive and cover several key areas:

Independent Claims

The independent claims focus on the specific compositions of the oral cannabinoid formulations, the methods for their preparation, and the delivery systems. For example, Claim 1 might describe a specific formulation of dronabinol with particular excipients and solubilizing agents[1].

Dependent Claims

The dependent claims further specify the details of the independent claims, such as the concentration of dronabinol, the types of excipients used, and the pH range of the aqueous buffer solutions[1].

Patent Landscape

The patent landscape surrounding US 10,265,293 is complex and involves multiple related patents.

Related Patents

Other patents, such as US 11,253,472, US 10,265,293, and US 9,345,771, also owned by Benuvia Operations LLC, protect similar aspects of oral and liquid cannabinoid formulations. These patents collectively form a robust intellectual property portfolio that safeguards the company's innovations in this field[2][5].

Expiration Dates

All these patents, including US 10,265,293, are set to expire in August 2028. This expiration date is crucial as it will open up the market for generic versions of these formulations once the patents lapse[5].

Impact on the Pharmaceutical Industry

The impact of US 10,265,293 and related patents on the pharmaceutical industry is significant:

Innovation and Competition

These patents have driven innovation in the development of oral cannabinoid formulations, providing patients with more effective and reliable treatment options. However, they also limit competition by preventing other companies from developing similar products until the patents expire[3].

Market Dominance

Benuvia Operations LLC's control over these patents allows the company to maintain market dominance in the oral cannabinoid market. This dominance is expected to continue until the patents expire in 2028[5].

Legal and Regulatory Aspects

The legal and regulatory environment surrounding these patents is also important:

Patent Litigation

The patents have been involved in various legal activities, including maintenance fee payments and changes in power of attorney. These activities indicate the ongoing efforts to protect and maintain the intellectual property rights associated with these patents[2][5].

Regulatory Compliance

Compliance with regulatory requirements is crucial for the continued validity of these patents. The patents must adhere to FDA regulations and other pharmaceutical standards to ensure their legitimacy and enforceability[1].

Future Implications

As the expiration dates of these patents approach, several implications arise:

Generic Competition

The expiration of these patents in 2028 will likely lead to increased competition from generic manufacturers, potentially reducing the market share of Benuvia Operations LLC and lowering the cost of these medications for consumers[5].

Continued Innovation

The expiration of these patents may also spur further innovation as other companies enter the market and develop new or improved formulations of oral cannabinoids.

Key Takeaways

• Patent Scope: US 10,265,293 covers oral cannabinoid formulations, including composition, preparation methods, and delivery systems.
• Claims: The patent includes independent and dependent claims that specify the details of the formulations and methods.
• Patent Landscape: The patent is part of a broader portfolio of related patents protecting oral and liquid cannabinoid formulations.
• Expiration Dates: All related patents are set to expire in August 2028.
• Impact: The patents drive innovation, limit competition, and allow Benuvia Operations LLC to maintain market dominance.

FAQs

1. What is the main subject of US Patent 10,265,293?

   • The main subject is oral cannabinoid formulations, specifically dronabinol formulations.

2. Who owns US Patent 10,265,293?

   • Benuvia Operations LLC owns this patent.

3. When do the patents related to US 10,265,293 expire?

   • The patents are set to expire in August 2028.

4. What are the implications of the patent expirations?

   • The expirations will likely lead to increased competition from generic manufacturers and potentially lower costs for consumers.

5. How do these patents impact the pharmaceutical industry?

   • They drive innovation, limit competition, and allow Benuvia Operations LLC to maintain market dominance in oral cannabinoid formulations.

Cited Sources

1. United States Patent and Trademark Office, "Oral Cannabinoid Formulations," US Patent 11,253,472 B2, February 22, 2022.
2. Pharsight, "Drug Patents containing Dronabinol," Pharsight.
3. SSRN, "Patent Claims and Patent Scope," September 29, 2016.
4. GreyB, "List - 30 Drug Patents Expiring in 2028," GreyB.
5. Pharsight, "Syndros patent expiration," Pharsight.

Drugs Protected by US Patent 10,265,293

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Benuvia Operations	SYNDROS	dronabinol	SOLUTION;ORAL	205525-001	Mar 23, 2017		DISCN	Yes	No			Y	Y