Details for Patent: 10,188,644

Which drugs does patent 10,188,644 protect, and when does it expire?

Patent 10,188,644 protects XTAMPZA ER and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 10,188,644

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:	US15/950,656
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,188,644
Patent Claim Types: see list of patent claims

Understanding the Scope and Claims of United States Patent 10,188,644

Introduction to Patent 10,188,644

United States Patent 10,188,644, titled "Process of making stable abuse-deterrent oral formulations," is a significant patent in the pharmaceutical industry. This patent, granted to its inventors, outlines a method for manufacturing extended-release microparticles designed to reduce the potential for improper administration of drugs.

Overview of the Patent

Publication Details

• Publication Number: US10188644B2
• Authority: United States
• Prior Art Date: This patent builds on previous research and technologies related to pharmaceutical compositions and microparticles[4].

Key Components

The patent focuses on the development of cured pharmaceutical compositions, specifically extended-release microparticles. These formulations are designed to deter abuse by making it difficult to manipulate the drug for improper use, such as crushing or dissolving the formulation to achieve a rapid release of the active ingredient.

Claims of the Patent

Independent and Dependent Claims

The patent includes a series of claims that define the scope of the invention. These claims can be categorized into independent and dependent claims.

• Independent Claims: These claims stand alone and define the core aspects of the invention. For example, Claim 1 might describe the overall process of making the stable abuse-deterrent oral formulations.
• Dependent Claims: These claims build upon the independent claims and provide additional details or specific embodiments of the invention. For instance, a dependent claim might specify the type of microparticles used or the conditions under which the curing process is conducted[4].

Claim Structure

The claims are structured to provide a clear and detailed description of the invention, including the materials, processes, and resulting products. This structure is crucial for defining the patent's scope and ensuring that it is distinct from prior art.

Technical Aspects of the Invention

Microparticles and Pharmaceutical Composition

The patent describes the use of microparticles as a key component in the abuse-deterrent formulations. These microparticles are designed to release the drug over an extended period, reducing the potential for abuse.

• Curing Process: The curing process is a critical step in stabilizing the microparticles. This involves treating the microparticles under specific conditions to enhance their stability and ensure consistent drug release[4].

Stability Studies

The patent emphasizes the importance of stability studies to ensure the quality and efficacy of the formulations. These studies include tests for potency, purity, microbial attributes, and drug release rate using standardized dissolution apparatus.

Economic and Legal Implications

Patent Landscape

The patent landscape for pharmaceutical formulations, especially those related to abuse-deterrent technologies, is complex and highly competitive. Patents like US10188644B2 play a crucial role in protecting innovations and encouraging further research and development.

• Patent Trolls: The issue of patent trolls, which are businesses that primarily exist to bring patent infringement lawsuits, is a significant concern in the tech and pharmaceutical industries. Laws and initiatives aimed at combating patent trolls, such as those supported by Attorney General Josh Stein, are essential for protecting genuine innovators[2].

Small Claims Patent Court

There is an ongoing discussion about the feasibility of a small claims patent court, which could simplify and reduce the costs associated with patent litigation. This initiative, studied by the Administrative Conference of the United States (ACUS), aims to make the patent system more accessible and efficient for smaller entities and individual inventors[5].

Impact on the Pharmaceutical Industry

Innovation and Competition

Patents like US10188644B2 drive innovation in the pharmaceutical industry by protecting new technologies and formulations. This protection encourages investment in research and development, leading to the creation of new and improved drugs.

• Economic Benefits: The development of abuse-deterrent formulations can have significant economic benefits by reducing healthcare costs associated with drug abuse and improving patient outcomes.

Regulatory Compliance

The patent highlights the importance of regulatory compliance in the pharmaceutical industry. The formulations described must meet stringent regulatory standards, including those related to stability, potency, and purity.

Conclusion

United States Patent 10,188,644 represents a significant advancement in the field of pharmaceutical formulations, particularly in the development of abuse-deterrent technologies. Understanding the scope and claims of this patent is crucial for both innovators and practitioners in the industry.

Key Takeaways

• Abuse-Deterrent Formulations: The patent describes a process for making stable abuse-deterrent oral formulations using extended-release microparticles.
• Claims Structure: The patent includes independent and dependent claims that define the scope of the invention.
• Technical Aspects: The curing process and stability studies are critical components of the invention.
• Economic and Legal Implications: The patent is part of a complex patent landscape and has implications for innovation, competition, and regulatory compliance.
• Industry Impact: The patent drives innovation and has economic benefits by reducing healthcare costs associated with drug abuse.

FAQs

Q: What is the main focus of United States Patent 10,188,644? A: The main focus is on a process for making stable abuse-deterrent oral formulations using extended-release microparticles.

Q: Why are stability studies important for this patent? A: Stability studies are crucial to ensure the quality and efficacy of the formulations, including tests for potency, purity, microbial attributes, and drug release rate.

Q: How does this patent impact the pharmaceutical industry? A: It drives innovation, encourages investment in research and development, and has significant economic benefits by reducing healthcare costs associated with drug abuse.

Q: What are the legal implications of this patent? A: The patent is part of a complex legal landscape and is protected under U.S. patent laws, with implications for patent trolls and the potential for a small claims patent court.

Q: Who can benefit from this patent? A: Innovators, pharmaceutical companies, and healthcare providers can benefit from the technology described in this patent.

Sources

1. Google Patents - Process of making stable abuse-deterrent oral formulations, US10188644B2.
2. NCDOJ - Attorney General Josh Stein Leads Coalition Fighting Against Patent Trolls.
3. USPTO - Patent Claims Research Dataset.
4. Google Patents - Process of making stable abuse-deterrent oral formulations, US10188644B2.
5. ACUS - U.S. Patent Small Claims Court.

Drugs Protected by US Patent 10,188,644

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 10,188,644

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