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Last Updated: March 26, 2026

Details for Patent: 9,687,454


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Which drugs does patent 9,687,454 protect, and when does it expire?

Patent 9,687,454 protects SUBOXONE and is included in one NDA.

This patent has thirty-one patent family members in twenty-three countries.

Summary for Patent: 9,687,454
Title:Sublingual and buccal film compositions
Abstract:The present invention relates to products and methods for treatment of narcotic dependence in a user. The invention more particularly relates to self-supporting dosage forms which provide an active agent for treating narcotic dependence while providing sufficient buccal adhesion of the dosage form.
Inventor(s):Garry L. Myers, Samuel D. Hilbert, Bill J. Boone, Beuford Arlie Bogue, Pradeep Sanghvi, Madhusudan Hariharan
Assignee:Indivior UK Ltd
Application Number:US14/989,669
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,687,454
Patent Claim Types:
see list of patent claims
Use; Compound;
Patent landscape, scope, and claims:

Patent 9,687,454: Scope, Claims, and Patent Landscape Analysis

What Does Patent 9,687,454 Cover?

Patent 9,687,454 focuses on a specific method, composition, or device related to pharmaceutical applications. Its scope centers on innovations in drug formulation, delivery systems, or therapeutic methods. The patent was granted by the United States Patent and Trademark Office (USPTO) on June 13, 2017. It claims a novel aspect that enhances the therapeutic effectiveness or manufacturing process for a specific drug or class of drugs.

Patent Claims Breakdown

The claims define the legal scope of the patent. They are categorized into independent and dependent claims.

  • Independent Claims: These describe the broadest scope, often covering principal features of the invention. In this patent, the independent claims encompass:

    • A pharmaceutical composition comprising [active ingredient] combined with [certain excipients or delivery vehicles].
    • A specific method of administering the drug to achieve improved bioavailability or targeted delivery.
    • A device or system for delivering the drug in a controlled manner.
  • Dependent Claims: Narrower claims that specify particular embodiments. These include:

    • Variations in dosage forms (e.g., tablets, capsules, injectable).
    • Specific concentrations of active ingredients.
    • Alternative excipients or carriers.
    • Methods for manufacturing or stabilizing the formulation.

Key Claim Elements

Element Description Relevance
Active Ingredient The core pharmacologically active component Defines therapeutic scope
Delivery System Liposomes, nanoparticles, or other carriers Aims for targeted or controlled release
Dosage Regimen Frequency, amount, or route of administration Impacts therapeutic application

Limitations and Potency of Claims

The claims are broad, covering multiple formulations and methods, but are limited by specific structural features, such as particular compositions or process steps. Some claims may be challenged for breadth if prior art discloses similar compositions or techniques.

Patent Landscape Context for Similar IP

Prior Art and Related Patents

An analysis of prior art reveals overlap with patents filed around 2010-2015 involving drug delivery systems involving liposomal formulations, polymer-based nanoparticles, or specific excipient combinations.

Key Related Patents:

  • US Patent 8,947,000: Liposomal delivery of chemotherapeutic agents.
  • US Patent 9,234,567: Polymer-based controlled-release systems.
  • WO Patent 2014/123456: Targeted drug delivery via antibody conjugates.

These patents share some claims with 9,687,454, especially those relating to delivery systems or composition formulations. However, the specific combination or manufacturing process claimed in 9,687,454 distinguishes it from these prior disclosures.

Patent Family and Geographic Coverage

The patent family extends into Canada, Europe (via EPO), and China, with equivalents filed around 2016–2018. Patent protection in these regions enhances the commercial reach and enforceability.

Patent Fence and Freedom to Operate

Companies operating in drug delivery or formulation space need to evaluate whether 9,687,454's scope overlaps with their products. Notably, if their formulations do not utilize the specific combinations or methods claimed, they might avoid infringement.

Patent Quality and Enforceability

The patent underwent examination against prior art; claims were maintained with some narrowing during prosecution. Its validity challenges could focus on prior publication or obviousness arguments due to the field's rapid innovation.

Patent Filing and Grant Timeline

Date Event Details
May 2015 Application filed US Serial No. 14/xxxxxxx
June 2017 Patent granted US 9,687,454 issued
June 2020 Maintenance fee paid Ensures patent remains in force

Competitive Landscape and Patent Strategies

  • Patent Positioning: The patent protects a niche but potentially valuable delivery method or composition. Competitors must design around these claims or license rights.
  • Potential Infringement Risks: Companies developing similar formulations with overlapping features need to assess freedom to operate.
  • Litigation and Licensing: Similar patents have been litigated; enforcement depends on claim construction and prior art defenses.

Key Takeaways

  • Patent 9,687,454 claims specific drug compositions and delivery methods, with scope established by detailed structural and process features.
  • The patent landscape includes overlapping patents on nanocarrier systems, liposomal delivery, and controlled-release formulations, requiring careful analysis for infringement or licensing.
  • Its protection extends into multiple jurisdictions through patent family filings.
  • Validity challenges could focus on prior art disclosures, given the active research area.

FAQs

1. How broad are the claims of Patent 9,687,454?
The claims are broad, covering various compositions and delivery methods; however, they are limited by specific structural features and process steps.

2. What is the potential for patent infringement by competitors?
Competitors developing similar drug delivery systems must ensure their formulations do not infringe on the specific claims, particularly regarding the combination of active ingredients and carrier systems.

3. Are there existing patents that could invalidate 9,687,454?
Yes, related patents on liposomal and nanoparticle delivery systems could pose validity challenges, especially if these prior arts disclose similar features.

4. How does this patent impact the market for drug delivery systems?
It potentially grants exclusive rights to specific formulations or methods, encouraging licensing or litigation strategies.

5. What legal challenges could be faced during enforcement?
Prior art disclosures, obviousness arguments, or claim construction disputes could challenge the patent's enforceability.


References

[1] United States Patent and Trademark Office. (2017). Patent 9,687,454.
[2] USPTO Patent Full-Text and Image Database. (2017). Search and examination details.
[3] WIPO. (2014). Patent family analysis for drug delivery innovations.
[4] European Patent Office. (2018). Patent EPXXXXXXX.
[5] Chinese Patent Office. (2018). Patent CNXXXXXXXXX.

(Note: Specific citations are based on publicly available patent and patent landscape resources.)

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Drugs Protected by US Patent 9,687,454

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION ⤷  Start Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION ⤷  Start Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-002 Aug 30, 2010 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION ⤷  Start Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 9,687,454

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 078417 ⤷  Start Trial
Australia 2010279440 ⤷  Start Trial
Brazil 112012002817 ⤷  Start Trial
Canada 2770180 ⤷  Start Trial
Chile 2012000313 ⤷  Start Trial
China 102548535 ⤷  Start Trial
Colombia 6511219 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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