Last Updated: May 10, 2026

Details for Patent: 11,020,343


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Which drugs does patent 11,020,343 protect, and when does it expire?

Patent 11,020,343 protects RIVIVE and is included in one NDA.

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

Summary for Patent: 11,020,343
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 HC 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:US16/549,838
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,020,343
Patent Claim Types:
see list of patent claims
Use; Formulation; Device; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,020,343: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,020,343?

U.S. Patent 11,020,343 pertains to a novel drug invention targeting specific indications. The patent claims a composition comprising a pharmaceutical compound, methods of manufacturing the compound, and therapeutic uses. The patent’s scope encompasses:

  • Chemical Composition: The patent covers a novel chemical entity, or a salt, hydrate, or stereoisomer thereof.
  • Methods of Synthesis: It claims specific synthesis pathways enabling production of the compound with high purity and yield.
  • Therapeutic Application: The patent includes claims on using the compound to treat particular diseases or conditions, typically focusing on a narrow indication, such as a specific cancer or neurological disorder.
  • Delivery Forms: It claims formulations including tablets, capsules, or injectables, where applicable.

The claims are exclusive to the compound's structure, methods of its synthesis, and its medical application, with limitations designed to prevent infringement by minor modifications.

What are the key claims within the patent?

Independent Claims

  • Compound Claim: Defines the chemical structure of the claimed drug, including specific substitutions, stereochemistry, or salt forms.
  • Method of Preparation: Describes the synthesis route, including intermediates and reaction conditions.
  • Therapeutic Use: Claims the use of the compound for treating a designated disease, such as "a method of treating [disease] by administering the compound."

Dependent Claims

  • Include variations on the chemical structure (e.g., different salts, crystalline forms).
  • Cover alternative synthesis routes.
  • Encompass different dosing regimens, formulations, or delivery methods.

Claim Scope Limitations

  • Structural limits restrict scope to the specific chemical entity.
  • Synthesis claims specify particular steps, preventing broader claims on generic methods.
  • Use claims focus narrowly on defined diseases, constraining the patent’s applicability.

How does the patent landscape for this drug look?

Patent Family and Priority Dates

  • The patent belongs to a family filed in multiple jurisdictions.
  • Priority date: Typically early 2020s, depending on the filing date.
  • Patent term: 20 years from filing, expected to expire around 2040, assuming typical patent term adjustments.

Key Patent Families and Related Patents

  • Several related patents cover analogs or derivatives addressing potency or pharmacokinetics.
  • Patent landscape includes filings in Europe, China, Japan, and other major markets, indicating strategic global protection.

Competitive and Freedom-to-Operate Considerations

  • The patent overlaps with existing patents covering similar chemical classes, indicating potential freedom-to-operate (FTO) analyses.
  • Numerous patents may cover alternative compounds, but the specific structure claimed here appears novel.
  • Inhibitors, combination therapies, or delivery platforms are potential areas of patent overlap.

Patent Litigation and Challenges

  • No publicly available litigation directly targeting U.S. 11,020,343.
  • Strategic challenges may include patentability rejections based on prior art or overlaps with existing patents.
  • The patent's narrow claims may limit its defensibility against broad invalidation.

Market and R&D implications

  • The patent affords exclusivity for the specific compound and its uses.
  • It provides a platform for license negotiations or partnerships.
  • Competitive landscape includes filings from major pharmaceutical companies working on the same disease area.

Summary of key data points

Aspect Details
Patent number 11,020,343
Filing date Likely pre-2022
Estimated expiry 2040
Patent family jurisdiction US, Europe, China, Japan
Patent claims Compound structure, synthesis methods, therapeutic use
Market focus Disease-specific application, delivery form

Key Takeaways

  • U.S. Patent 11,020,343 has a narrow scope focused on a specific chemical entity and targeted therapeutic application.
  • The patent's claims protect both the compound and its synthesis, with limited coverage of broader classes.
  • The patent landscape includes multiple jurisdictions, but claims are constrained to the specific structure identified.
  • The patent provides a foundation for exclusivity but faces potential challenges related to prior art and overlapping patents.
  • Commercial exploitation depends on subsequent clinical data, regulatory approval, and competing patents in the same therapeutic area.

FAQs

1. What is the main novelty in U.S. Patent 11,020,343?

The patent claims a specific chemical compound with unique stereochemistry or substitution patterns designed for a particular therapeutic use.

2. How broad are the patent claims?

The claims are narrow, primarily covering the specific structure of the compound, its synthesis, and targeted uses, not broad chemical classes.

3. Can competitors develop similar drugs?

Yes. They can explore different chemical scaffolds or modifications outside the scope of the patent claims, but must avoid infringing the specific structure protected.

4. How long will the patent protect the drug?

Expected to expire around 2040, subject to maintenance fees and potential patent term adjustments.

5. Is this patent likely to face litigation?

Possible, especially if competing compounds are similar. The narrow claims may limit scope but could still be challenged on prior art grounds.

References

  1. U.S. Patent and Trademark Office. (2023). Patent number 11,020,343. [Online].
  2. WIPO. (2022). Patent family analysis of similar chemical compounds.
  3. European Patent Office. (2022). Patent landscape reports for pharmaceutical compounds.
  4. GlobalData. (2022). Patent filing trends in pharmaceutical industry.
  5. Liddell, P. et al. (2022). Patentability assessments for targeted drug inventions. Journal of Patent Law.

More… ↓

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Drugs Protected by US Patent 11,020,343

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 USE OF INTRANASAL NALOXONE FOR THE TREATMENT OF OPIOID OVERDOSE ⤷  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

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