Details for Patent: 10,646,485

Which drugs does patent 10,646,485 protect, and when does it expire?

Patent 10,646,485 protects XTAMPZA ER and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 10,646,485

Title:	Process of making stable abuse-deterrent oral formulations
Abstract:	The present disclosure relates to cured pharmaceutical compositions designed to reduce the potential for improper administration of drugs that are subject to abuse, the process of curing such composition in order to improve the dissolution stability, method of using the same for treatment of pain.
Inventor(s):	Said Saim, Alison B. Fleming, Ravi K. Varanasi
Assignee:	Collegium Pharmaceutical Inc
Application Number:	US16/218,801
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope and Claims of United States Patent 10,646,485

Overview of the Patent

United States Patent 10,646,485, titled "Process of Making Stable Abuse-Deterrent Oral Formulations," was issued on May 12, 2020, to Collegium Pharmaceutical, Inc. The inventors listed are Said Saim, Alison B. Fleming, and Ravi K. Varanasi. This patent is part of a series of innovations aimed at developing pharmaceutical compositions that deter abuse, particularly for drugs used in pain treatment.

Scope of the Patent

The patent focuses on the development and manufacturing process of cured pharmaceutical compositions designed to reduce the potential for improper administration of drugs that are subject to abuse. Here are the key aspects of the scope:

Abuse-Deterrent Formulations

The patent describes formulations that are resistant to tampering and abuse. These formulations are designed to prevent or deter the extraction of the active pharmaceutical ingredient (API) through various methods such as crushing, grinding, or dissolving in solvents, which are common techniques used by individuals attempting to misuse these drugs[2][4].

Curing Process

The process involves a curing step that enhances the dissolution stability of the pharmaceutical composition. This curing step is crucial as it ensures that the formulation maintains its extended-release characteristics even when subjected to various forms of tampering[2][4].

Extended-Release Compositions

The patent covers extended-release compositions that are designed to release the API over a prolonged period. This is particularly important for pain management, as it ensures a consistent therapeutic effect without the need for frequent dosing[2][4].

Methods of Use

The patent also includes methods of using these compositions for the treatment of pain. The formulations are intended to provide effective pain relief while minimizing the risk of abuse and misuse[2][4].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

Composition Claims

The claims describe the specific composition of the abuse-deterrent formulations, including the type and amount of API, the matrix material, and other excipients used to enhance stability and deter tampering[1][2].

Process Claims

These claims outline the steps involved in the manufacturing process, including the curing step, which is critical for achieving the desired dissolution stability and abuse-deterrent properties[1][2].

Method of Use Claims

The patent claims also cover the methods of using these compositions for pain treatment, emphasizing the therapeutic benefits and the safety features designed to prevent abuse[1][2].

Patent Landscape Analysis

To understand the broader context and strategic implications of this patent, a patent landscape analysis is essential.

Geographical Spread

The geographical spread of this technology is primarily within the United States, given that the patent is issued by the U.S. Patent and Trademark Office. However, the impact and relevance of this technology can be global, especially in regions where opioid abuse is a significant concern[3].

Saturation of Patent Space

The patent space for abuse-deterrent pharmaceutical formulations is relatively saturated, with multiple patents and patent applications filed by various companies, including Collegium Pharmaceutical, Inc. This saturation indicates a high level of competition and innovation in this area[2][3].

Competitors and New Entrants

Key competitors in this space include other pharmaceutical companies that have developed or are developing similar abuse-deterrent formulations. New entrants may face significant challenges due to the existing patent landscape and the need to differentiate their products through novel formulations or manufacturing processes[3].

Time-Slicing and Trends

Analyzing the patent landscape over time reveals a consistent trend of innovation in abuse-deterrent technologies. The series of patents filed by Collegium Pharmaceutical, Inc., including U.S. Patent 10,646,485, indicates a continuous effort to improve and expand their portfolio in this area[2][4].

Niche Areas

There may be underappreciated niche areas within the broader category of abuse-deterrent formulations. For example, formulations tailored for specific types of pain or patient populations could represent untapped opportunities for innovation and market differentiation[3].

Strategic Insights

Entry Barriers

Entering the market for abuse-deterrent pharmaceutical formulations can be challenging due to the high saturation of patents. Companies must conduct thorough patentability searches and landscape analyses to identify potential gaps and opportunities[3].

Innovation and Differentiation

To succeed, new entrants must innovate beyond existing technologies. This could involve developing new curing processes, novel matrix materials, or other unique features that enhance the abuse-deterrent properties of the formulations[2][3].

Collaboration and Licensing

Collaboration with existing players or licensing agreements can be strategic moves to navigate the complex patent landscape. This approach can help new entrants leverage existing technologies while contributing their own innovations[3].

Key Takeaways

• Abuse-Deterrent Formulations: The patent focuses on developing pharmaceutical compositions that resist tampering and abuse.
• Curing Process: The curing step is crucial for enhancing dissolution stability and maintaining extended-release characteristics.
• Extended-Release Compositions: These formulations are designed for pain management, providing consistent therapeutic effects.
• Patent Landscape: The space is highly saturated, with multiple competitors and a need for continuous innovation.
• Strategic Insights: New entrants must innovate, differentiate, and potentially collaborate or license existing technologies to succeed.

FAQs

1. What is the primary focus of U.S. Patent 10,646,485?

   • The primary focus is on the development and manufacturing process of cured pharmaceutical compositions designed to reduce the potential for improper administration of drugs subject to abuse.

2. Who are the inventors of this patent?

   • The inventors are Said Saim, Alison B. Fleming, and Ravi K. Varanasi.

3. What is the significance of the curing process in this patent?

   • The curing process enhances the dissolution stability of the pharmaceutical composition, ensuring it maintains its extended-release characteristics even when tampered with.

4. When does the patent expire?

   • The patent expires on September 2, 2036[2].

5. How does this patent fit into the broader patent landscape for abuse-deterrent formulations?

   • It is part of a highly saturated patent space, indicating a high level of competition and innovation in this area, and highlights the need for continuous differentiation and innovation to succeed.

Cited Sources

1. United States Patent and Trademark Office. US Patent 10,646,485 B2, May 12, 2020.
2. Drugs.com. Generic Xtampza ER Availability, November 6, 2024.
3. AcclaimIP. Patent Landscape Analysis - Uncovering Strategic Insights.
4. Justia Patents. US Patent Application for PROCESS OF MAKING STABLE ABUSE ..., May 5, 2023.

Drugs Protected by US Patent 10,646,485

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-001	Apr 26, 2016		RX	Yes	No			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016		RX	Yes	No			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016		RX	Yes	No			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016		RX	Yes	No			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016		RX	Yes	Yes			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

International Family Members for US Patent 10,646,485

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2017222575