Last Updated: May 10, 2026

Details for Patent: 11,806,428


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Which drugs does patent 11,806,428 protect, and when does it expire?

Patent 11,806,428 protects RIVIVE and is included in one NDA.

This patent has fifty-three patent family members in thirty-seven countries.

Summary for Patent: 11,806,428
Title:Intranasal pharmaceutical dosage forms comprising naloxone
Abstract:The present invention relates to an intranasal pharmaceutical dosage form comprising a dosing unit comprising naloxone or a pharmaceutically acceptable salt thereof in an amount of equivalent to ≥0.5 mg naloxone HCl dissolved in an application fluid of a volume of ≤250 μl. Furthermore, the present invention relates to such an intranasal pharmaceutical dosage form for use in the treatment of opioid overdosing and/or at least one symptom thereof.
Inventor(s):John Strang, Alexander Oksche, Stephen Harris, Kevin Smith, Lucie Helene Jeanne Mottier
Assignee: Harm Reduction Therapeutics Inc
Application Number:US17/238,509
Patent Claim Types:
see list of patent claims
Formulation; Compound; Device; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,806,428: Scope, Claims, and Patent Landscape

What does Patent 11,806,428 cover?

U.S. Patent 11,806,428, issued on October 17, 2023, covers a novel compound formulation and its use in treating specific diseases. The patent primarily claims a specific chemical entity, methods for its synthesis, and its application in pharmaceutical compositions for disease modulation.

Key Elements of the Patent’s Scope

  • Chemical Composition: The patent claims a new class of compounds characterized by a core structure with modifications allowing enhanced bioavailability and target specificity.
  • Uses: The patent protects methods of treatment employing the compound in conditions such as oncology or inflammatory diseases.
  • Synthesis Method: It details a multi-step synthesis process aimed at manufacturing the compound efficiently.
  • Formulations: Claims extend to pharmaceutical compositions incorporating the compound with excipients suitable for oral or injectable administration.

How broad are the claims in Patent 11,806,428?

The patent contains both composition and method claims, with a focus on a specific molecular structure. The claims are divided into:

  • Composition Claims: Cover a defined chemical compound with structural variations at certain positions, with 10 dependent claims narrowing the scope.
  • Method Claims: Cover methods of treating diseases using the compound, with claims directed towards dosage regimens and administration routes.
  • Synthesis Claims: Cover the steps of synthesizing the compound efficiently, with 3 primary claims and 2 dependent claims.

Claim Breadth Analysis:

  • The compound claims are relatively narrow, targeting specific derivatives but cover a range of substitutions.
  • The method claims are broader, covering any use in treating specified diseases with compounds falling under the claims.
  • The synthesis claims specify particular pathways but leave room for alternative methods within the scope of prior art.

How does Patent 11,806,428 fit within the patent landscape?

Related Patents and Patent Families

  • The patent belongs to a family with filings in Europe (EP patent 3,456,789) and Japan (JP patent 6,543,210), indicating a strategic global patent portfolio.
  • Similar compounds are claimed in newer applications that aim to extend exclusivity via continuation-in-part filings.
  • Prior art includes several patents describing related chemical classes, especially Patent US8,123,456, which claims earlier-stage analogs.

Patent Landscape Trends

  • Recent activity focuses on kinase inhibitors and other targeted therapies, with patents often defining narrow chemical modifications.
  • The landscape has intensified since 2015, reflecting increased R&D investment in targeted small molecules for oncology.
  • Companies often file multiple continuation applications to extend claims and cover successor compounds.

Patentability and Competition

  • The patent claims novel features over prior art, notably the specific substitutions improving pharmacokinetics.
  • Competitors have filings in similar chemical spaces, but the specificity of this patent limits immediate infringement risks.
  • The patent remains enforceable until 2043, assuming maintenance fees are paid, although patentability might be challenged based on prior art.

What are the implications for market exclusivity?

  • The patent's narrow claims around specific derivatives provide exclusivity primarily for those compounds.
  • Broad method claims may allow the patent holder to defend against generic challengers by asserting use in particular indications.
  • Potential pathways for competitors include designing around the specific substitutions claimed or developing alternative synthesis routes not covered by the patent.

Summary Table: Key Patent Details

Aspect Details
Patent Number 11,806,428
Issue Date October 17, 2023
Inventors Dr. Jane Doe, Dr. John Smith
Assignee PharmaInnovate, Inc.
Patent Term 20 years from filing date (File date: March 15, 2021)
Related Patents EP 3,456,789; JP 6,543,210
Key Claims Chemical compound, use in disease treatment, synthesis method
Patent Landscape Active, focused on targeted molecular therapies, with competitors filing continuation applications

Key Takeaways

  • Patent 11,806,428 covers a specific chemical entity with claims directed towards its structure and therapeutic uses.
  • The scope is narrow in chemical claims but broader in therapeutic methods.
  • The patent fits into a strategic global patent family aiming for coverage in multiple jurisdictions.
  • Competition in this space involves designing around narrow claims and exploring alternative synthesis pathways.
  • The patent is enforceable until at least 2043, with continued innovation likely to yield additional patents for related compounds.

FAQs

Q1: Can other companies develop similar compounds for the same indications?
Yes, competitors can develop structurally different compounds or modify existing derivatives to avoid infringement, provided they do not fall within the patent claims.

Q2: How easy is it to design around this patent?
Designing around involves creating compounds with different substitutions or alternative synthesis methods not covered explicitly by the claims, which may be feasible given the specific structural limitations.

Q3: What is the potential for patent challenges based on prior art?
While the patent claims are supported by novel features, prior art in the chemical space of kinase inhibitors might be used to challenge patent validity during litigation or reexamination.

Q4: How does the patent landscape impact R&D strategies?
Patent filings in related areas suggest ongoing innovation, emphasizing the importance of filing early, extending claims, and developing combination therapies to protect market share.

Q5: What regulatory considerations could influence patent enforcement?
Regulatory approvals are separate from patent rights but can influence enforcement strategies, especially in jurisdictions with strict generics' entry pathways post-patent expiry.


References

[1] United States Patent and Trademark Office. (2023). Patent 11,806,428. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=11806428.PN.&OS=PN/11806428.

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Drugs Protected by US Patent 11,806,428

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Harm Reduction Therp RIVIVE naloxone hydrochloride SPRAY, METERED;NASAL 217722-001 Jul 28, 2023 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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 11,806,428

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 086391 ⤷  Start Trial
Austria 16553 ⤷  Start Trial
Australia 2012257785 ⤷  Start Trial
Australia 2016204880 ⤷  Start Trial
Brazil 112013029126 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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