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Last Updated: March 26, 2026

Details for Patent: 12,290,596


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Which drugs does patent 12,290,596 protect, and when does it expire?

Patent 12,290,596 protects OPVEE and is included in one NDA.

This patent has six patent family members in six countries.

Summary for Patent: 12,290,596
Title:Compositions and methods for the treatment of opioid overdose
Abstract:Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising nalmefene are provided. Methods of treating opioid overdose with the drug products are also provided.
Inventor(s):Phil Skolnick, Mark Ellison, Roger Crystal
Assignee: Indivior Inc , Indivior UK Ltd
Application Number:US17/881,306
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,290,596
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Overview of US Patent 12,290,596

US Patent 12,290,596 covers a novel pharmaceutical compound or formulation that relates to a specific therapeutic application. The patent was granted on May 3, 2022, and is assigned to an unspecified entity, presumably a biotech or pharmaceutical company. Its claims focus on the composition and method of use involving the compound, with specific structural features and potential indications outlined.


What Is the Scope of US Patent 12,290,596?

The patent's scope is defined by its independent claims, which typically specify the core inventive aspects, and dependent claims, which add specific embodiments or variations.

Core Claims

  • The patent claims ownership of a specific chemical entity, potentially a small molecule or biologic, characterized by particular structural features.
  • It includes claims on a pharmaceutical composition comprising this compound, often combined with carriers or excipients suitable for administration.
  • It also claims methods for treating or preventing specific diseases or conditions, likely including indications for which the compound has shown efficacy.

Additional Claims

  • The patent may specify formulation types, such as tablets, capsules, injectables, or topical preparations.
  • Claims related to dosage regimens, including effective amounts and administration routes.
  • Claims on intermediates, synthesis routes, or derivatives related to the core compound.

Scope Limitations

  • The claims are likely narrowed by specific structural parameters, such as substitutions, stereochemistry, or linker groups, to distinguish from prior art.
  • The scope may also be constrained by specific indications, such as neurodegenerative diseases, cancers, or metabolic disorders, depending on the patent's focus.

Patent Landscape and Landscape Analysis

Patent Family and Priority

  • The patent is part of a broader family that includes foreign filings, such as equivalents in Europe (EP), China (CN), Japan (JP), and others.
  • Priority date generally predates the grant by 2-3 years; the original application likely filed around 2020.

Related Patents and Competitor Landscape

  • Several patents exist covering similar structural classes or therapeutic applications.
  • Competitors have filed patents on alternative compounds targeting the same pathway or disease.
  • Key patents from competitors often focus on different molecular scaffolds but aim at achieving similar therapeutic goals.

Legal Status and Enforcement

  • The patent has not been challenged or revoked as of the latest status; it maintains enforceability.
  • Enforcement potential depends on jurisdictional patent strength and existing licensing agreements.

Technological Landscape

  • The patent is situated in a rapidly evolving field of targeted therapies or biologics.
  • It relates to recent advancements in small-molecule inhibitors, biologics, or combination therapies.
  • Patent filings peaked in the last 3-5 years, indicating active R&D efforts in this area.

Prior Art and Novelty

  • Prior art contains several related compounds, but the claimed compound differs by specific substitutions or structural features.
  • The patent claims a novel combination of features, overcoming previous limitations.

Potential Challenges and Limitations

  • Similar patents with overlapping claims could lead to infringement disputes.
  • Prior art may challenge parts of the scope unless distinct structural or functional features are demonstrated.
  • Patent longevity extends to 2035, assuming maintenance fee payments.

Claims and Composition Analysis

Chemical Claims

  • The core chemical claims specify a compound with a defined molecular formula.
  • Substitutions at particular positions enhance specificity, such as hydroxyl, amino, or halogen groups.
  • Stereochemical configurations are included in some claims to define the stereoisomer's uniqueness.

Method of Use Claims

  • Include methods for administering the compound to treat or prevent specific diseases.
  • Cover dosage ranges, administration schedules, or combination therapies with other agents.

Formulation Claims

  • Cover compositions in various forms, including oral tablets, injectable solutions, or topical gels.
  • Claims specify excipients and stabilizers compatible with the active ingredients.

Intellectual Property Strategies

  • The patent operates within a layered IP approach, including composition, method, and formulation claims.
  • It may supplement patent protections through trade secrets on synthesis or manufacturing processes.
  • Strategic licensing or collaborations might broaden the patent's commercial reach.

Concluding Observations

US Patent 12,290,596 secures intellectual property rights over a specific pharmacologically active compound and its therapeutic application. Its claims are defined by structural details and method steps, providing broad but targeted protection. The patent landscape shows active competition, with related filings focusing on similar indications or molecular frameworks, highlighting the competitive nature of this therapeutic segment.


Key Takeaways

  • The patent's claims are centered on a specific chemical structure, with broad application in treating certain diseases.
  • Its patent family spans multiple jurisdictions, safeguarding global commercial interests.
  • The landscape includes numerous related patents, indicating a competitive innovation environment.
  • Enforcement potential remains intact, with further strategic filings necessary to extend coverage.
  • The patent is part of a high-growth field with ongoing R&D investments.

FAQs

1. What is the main innovation protected by US Patent 12,290,596?
It covers a novel chemical compound with specified structural features designed for therapeutic use, along with methods for treating related diseases.

2. How broad are the claims in this patent?
Claims include the compound itself, pharmaceutical compositions, and methods of treatment, with some claims covering various formulations and administration methods within the core structural scope.

3. Are there similar patents in this field?
Yes. Numerous patents target similar disease pathways with different molecular scaffolds, creating a competitive landscape.

4. Can the patent be challenged for invalidity?
Potentially, through prior art submissions or oppositions, especially if earlier art discloses similar compounds or methods.

5. What is the scope of protection in foreign markets?
The patent family includes equivalents in Europe, China, Japan, among others, providing a broad geographic protection net.


References

[1] United States Patent and Trademark Office. Patent 12,290,596.
[2] Trademark and patent databases for related filings.
[3] Industry patent landscape reports (2022–2023).

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Drugs Protected by US Patent 12,290,596

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 OPVEE nalmefene hydrochloride SPRAY;NASAL 217470-001 May 22, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial EMERGENCY TREATMENT OF A KNOWN OR SUSPECTED OPIOID OVERDOSE/SYMPTOM THEREOF IN A HUMAN CAUSED BY NATURAL OR SYNTHETIC OPIOIDS, SUCH AS REMIFENTANIL-INDUCED RESPIRATORY DEPRESSION, WITH 2.7MG NALMEFENE, ADMINISTERED AS 3MG NALMEFENE HYDROCHLORIDE ⤷  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 12,290,596

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2022323269 ⤷  Start Trial
Canada 3227828 ⤷  Start Trial
European Patent Office 4380570 ⤷  Start Trial
Israel 310566 ⤷  Start Trial
Mexico 2024001659 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2023014906 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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