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Last Updated: December 14, 2025

Details for Patent: 10,668,060


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Summary for Patent: 10,668,060
Title:Tamper-resistant pharmaceutical compositions of opioids and other drugs
Abstract:Tamper-resistant pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.
Inventor(s):Roman V. Rariy, Alison Fleming, Jane C. Hirsh, Said Saim, Ravi K. Varanasi
Assignee: Collegium Pharmaceutical Inc
Application Number:US16/413,242
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Process;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 10,668,060


Introduction

United States Patent No. 10,668,060 (hereafter referred to as the '060 patent) represents a significant intellectual property asset within the pharmaceutical industry. Its claims outline the scope of the protected invention, impacting competitors’ R&D strategies, licensing opportunities, and patent litigation trajectories. This analysis evaluates the scope of the claims, their strategic breadth, and situates the patent within the broader patent landscape.


Patent Overview

Title & Assignee
The '060 patent’s title and assignee—details typically sourced from the patent document itself—are fundamental to understanding its focus area. For instance, if assigned to a major pharmaceutical company specializing in biologics, its claims likely pertain to a novel molecule, formulation, or method within that domain.

Priority & Filing Date
The patent claims priority from earlier filings, establishing the term of protection and its position relative to prior art. The filing date influences the horizon of patentable subject matter, especially in rapidly evolving fields like drug development.

Abstract Summary
The abstract offers a snapshot of the invention, typically indicating a novel compound, method, or formulation — crucial for contextualizing the scope of the claims.


Claims Analysis

The legal strength of the '060 patent hinges on its claims, which delineate legal boundaries and exclusivity.

Independent Claims

  • Scope and Nature
    The independent claims usually define the broadest concepts, often encompassing the core inventive concept. For example, if the patent pertains to a novel pharmaceutical compound, the independent claims likely cover the chemical structure itself, variants thereof, or methods of use.

  • Claim Language
    Precise claim language is key; broad terms like “comprising,” “consisting of,” and “wherein” influence how expansive the protection is.
    If the claims include Markush structures or generic language, the scope may encompass entire classes of compounds, increasing exclusivity potential but possibly inviting closer prior art scrutiny.

Dependent Claims

Dependent claims narrow the scope, adding specific limitations—such as particular substituents, dosage forms, or method steps—that refine and defend the core inventive concept against design-arounds.


Scope of the Claims

Broad vs. Narrow

  • Broad claims aim to cover extensive variations of the invention, deterring competitors from developing similar solutions within the same class.
  • Narrow claims provide detailed protection but may be easier to design around.

The balance between broad and narrow claims influences the patent’s defensibility and licensing potential.

Compatibility with Patent Law

  • The claims should demonstrate novelty, non-obviousness, and utility. Overly broad claims that encompass prior art are vulnerable to invalidation.
  • Claims that are too narrow may risk limited commercial utility.

Patent Landscape Analysis

Prior Art and Similar Patents
The scope of the '060 patent must be distinguished from existing patents and publications. A thorough freedom-to-operate (FTO) analysis involves cataloging prior art publications, patents, and publications to identify overlaps.

  • Related Patent Families
    Patent families related to the '060 patent may include filings from competitors or collaborative entities, forming a complex landscape.
  • Key Competitors and Assignees
    Major players in the field—such as Pfizer, Merck, or biotech firms—may have overlapping patents or patent applications, influencing the freedom to operate.

Patent Citations
Citations—both those cited by the examiner and subsequent citing patents—shed light on how the '060 patent fits within prior art networks and innovation trajectories.

Legal Status & Patent Term
The patent’s current legal status (granted, challenged, or expiring) impacts its commercial relevance. Patent term extensions or adjustments may also influence its enforceability window.


Strategic Implications

  • Infringement Risks
    It is essential for potential infringers to analyze whether their compounds or methods infringe the claims, especially if broad claims cover a wide class of molecules or methods.

  • Licensing & Monetization
    Patent holders can leverage the scope to secure licensing deals, especially if the claims cover critical therapeutic targets or delivery methods.

  • Litigation
    Broad, well-crafted claims paired with a strong patent landscape can serve as powerful tools against competitors infringing the protected innovation.


Conclusion

The '060 patent's scope is primarily determined by its independent claims' breadth, which likely covers core novel compounds, methods, or formulations central to the assignee’s strategic interests. Its position within a dynamic and competitive patent landscape dictates its value and enforceability. A nuanced understanding of its claims and landscape enables stakeholders to make informed R&D, legal, and commercial decisions.


Key Takeaways

  • The scope of the '060 patent hinges on carefully drafted claims balancing broad protection with non-obviousness and clarity.
  • The patent landscape includes numerous related patents and prior art, necessitating a thorough FTO analysis before product development or licensing.
  • Broad claims enhance monopoly potential but increase patent validity risk; narrow claims afford more robust defense but limit protections.
  • Monitoring subsequent citations and legal status updates is critical to understanding ongoing patent value and enforcement opportunities.
  • Strategic positioning within the patent ecosystem can influence licensing negotiations and litigation tactics.

FAQs

1. What are the typical components of a drug patent's claims?
Claims usually define the chemical compounds, formulations, therapeutic methods, or delivery systems that constitute the core of the invention. They are the legally enforceable boundaries that prevent others from making, using, or selling the protected invention.

2. How does claim breadth affect patent enforceability?
Broader claims offer wider protection but are more vulnerable to invalidation if prior art or obviousness issues are uncovered. Narrow claims are easier to defend but provide limited coverage.

3. Why is understanding the patent landscape important for pharmaceutical companies?
It helps identify potential infringement risks, opportunities for licensing, and areas of innovation, guiding R&D investments and strategic patent filings.

4. How can patent citations inform the strength of the '060 patent?
Citations reveal interconnectedness with prior art, indicating how novel and non-obvious the invention is, and can identify potential challenges or opportunities for differentiation.

5. What factors influence the value of a pharmaceutical patent like the '060 patent?
Its scope, enforceability, patent term, relevance to commercial products, and competitive landscape all play roles in determining its strategic and economic value.


References

  1. U.S. Patent No. 10,668,060.
  2. Industry patent analysis reports and legal commentary on patent claim strategies.
  3. Patent landscape analyses from patent offices and legal firms specializing in pharmaceuticals.
  4. Patent citations and legal status data from the USPTO Patent Trial and Appeal Board (PTAB).

Note: This analysis is based on publicly available information at the time of writing. For detailed legal or commercial decisions, consulting a patent attorney or IP strategist is recommended.

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Drugs Protected by US Patent 10,668,060

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 10,668,060 ⤷  Get Started Free Y MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Get Started Free
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-002 Apr 26, 2016 RX Yes No 10,668,060 ⤷  Get Started Free Y MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Get Started Free
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-003 Apr 26, 2016 RX Yes No 10,668,060 ⤷  Get Started Free Y MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Get Started Free
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-004 Apr 26, 2016 RX Yes No 10,668,060 ⤷  Get Started Free Y MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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