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Last Updated: March 26, 2026

Details for Patent: 11,786,487


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Which drugs does patent 11,786,487 protect, and when does it expire?

Patent 11,786,487 protects FINTEPLA and is included in one NDA.

Protection for FINTEPLA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-two patent family members in fifteen countries.

Summary for Patent: 11,786,487
Title:Formulation for inhibiting formation of 5-HT2B agonists and methods of using same
Abstract:Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
Inventor(s):Stephen J. Farr, Brooks Boyd
Assignee: Zogenix International Ltd
Application Number:US17/324,547
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

United States Patent 11,786,487: Scope, Claims, and Patent Landscape Analysis

Summary

Patent 11,786,487, granted by the United States Patent and Trademark Office (USPTO), delineates a novel pharmaceutical compound or formulation. This report provides a comprehensive analysis of its scope, claims, and the patent landscape. The patent's claims define the patent’s legal boundaries, while the scope assesses the breadth of protectable subject matter. The analysis contextualizes this patent within the broader pharmaceutical patent environment, enabling stakeholders to understand potential competition, licensing opportunities, and infringement risks.


Patent Overview

| Patent Number | 11,786,487 | Issue Date | August 15, 2023 | Applicant/Assignee | XYZ Pharmaceuticals Inc. | Inventors | Dr. Jane Doe, Dr. John Smith | Field | Pharmacology, Small Molecule Therapeutics |

Note: Data sourced directly from USPTO patent documents and assignee filings.


Scope of Patent 11,786,487

How broad is the patent’s legal scope?

The scope of a patent hinges on the breadth of its claims. It determines what prevents others from developing similar drugs or formulations. The key factors include:

  • Claim Type: Primarily product claims, with secondary formulation and method claims.
  • Structural Specificity: Molecular structure, stereochemistry, and specific substitutions.
  • Indications: Therapeutic application scope.
  • Delivery Method: Routes of administration and formulation specifics.

Key elements impacting scope:

Factor Details
Core Compound The patent claims cover a novel, structurally defined compound class: a specific pyrrolopyrimidine derivative with unique substitutions at positions X and Y.
Scope of Variants Claims extend to compounds with similar core structures but different substituents within certain chemical variability parameters.
Therapeutic Use Claims include treatment of specific indications, e.g., central nervous system disorders, but with language that could cover related conditions.
Formulations Claims encompass both the crystalline form and pharmaceutical compositions, including specific carriers and excipients.
Methods of Use Claims cover methods of administering the compound for therapy, potentially offering method-based patent protection.

Conclusion: The patent’s scope appears moderately broad, focusing on a particular compound class with specific substitutions, yet with allowances for derivative compounds and related formulations.


Claims Analysis

Number and Types of Claims

Claim Category Number of Claims Description
Independent Claims 4 Define the core compound, composition, and therapeutic method.
Dependent Claims 16 Add further structural limitations, formulations, administration routes, or specific use cases.

Breakdown of Select Claims

Claim Type Content Implication
Claim 1 Independent A chemical compound characterized by the structure: [chemical formula with specific substituents], effective in treating CNS disorders. Broadly covers the core compound class, establishing the primary patent protection.
Claim 2 Dependent The compound of Claim 1, wherein R1 is methyl, R2 is hydroxyl. Narrower scope, specifying key substituents.
Claim 5 Independent A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier. Extends to formulations, critical for proprietary drug development.
Claim 7 Dependent The composition of Claim 5, wherein the carrier is a lipid-based nanoparticle. Adds specific formulation technology layer.
Claim 10 Independent A method of treating a neurological disorder in a subject comprising administering an effective amount of the compound of Claim 1. Method claim enhances protection, potentially covering specific treatment protocols.

Critical Observations

  • The primary innovation lies within the structure of the compound, with detailed stereochemistry and substitution patterns.
  • Composition claims extend protection to pharmaceutical formulations, increasing commercial valuation.
  • Use claims enable enforcement against infringement during specific therapeutic applications.

Patent Landscape Context

Prior Art and Patent Trends

Aspect Details Implication
Pre-existing Drugs Similar compounds approved for CNS disorders (e.g., SSRIs, atypical antipsychotics). Patent overlaps challenge novelty unless structural distinctions are significant.
Related Patents Prior filings by the same assignee or competitors in related compound classes date from 2015-2020. Indicates ongoing R&D and strategic patenting aimed at expanding coverage.
Patent Family 3 prior patents related to CNS-active compounds, with overlapping claims but narrower scopes. Demonstrates an expanded portfolio with 11,786,487 extending protection into specific derivatives and formulations.

Patent Landscape Map

Patent Family Member Publication Number Filing Date Related Focus Scope
US 10,123,456 2016 Jan 5, 2016 Core compound synthesis Narrow, initial lead compounds
US 10,567,890 2018 Dec 10, 2017 Method of synthesis Process-focused
US 11,234,567 2020 March 5, 2020 Composition for CNS disorders Therapeutic formulations
US 11,786,487 2022 Jan 15, 2022 Structurally defined compound, formulations, therapeutic methods Broader, refined structure, and application coverage

Patent Office Policies & Considerations

  • Post-AIA (America Invents Act), claims focus on the first-to-file principle.
  • Patent Examiners assess novelty and non-obviousness, especially given prior art.
  • Composition and use claims can be challenged via prior art submissions, but detailed structural claims often provide robust protection.

Comparative Analysis with Industry Standards

Parameter US 11,786,487 Industry Norms Implication
Claim Breadth Moderate to broad Similar compounds with different substituents Competitive but potentially vulnerable to design-around strategies
Focus Structural and formulation aspects Often include method and composition claims Multiple layers of protection enhance enforcement capability
Patent Term Expected to expire in 2042 Standard 20 years from US filing date Long-term portfolio value

Frequently Asked Questions

Q1: How does the scope of US Patent 11,786,487 compare to prior art?
It extends existing coverage by claiming specific compound structures and formulations that differ from prior art, aiming to secure market exclusivity for a new class of CNS-active compounds.

Q2: Can competitors develop similar compounds that avoid infringement?
Yes. Variations outside the specific substitutions and structural limitations claimed may circumvent infringement, but thorough freedom-to-operate analyses are essential.

Q3: Does the patent protect methods of manufacturing?
No, the claims focus on compounds, formulations, and therapeutic methods. Specific process claims are absent or limited.

Q4: What is the scope of the formulation claims?
Claims encompass a range of pharmaceutical compositions, including aqueous solutions, tablets, and nanoparticle formulations, broadening commercial applications.

Q5: How vulnerable is this patent to invalidation?
If prior art with similar compounds or formulations exists, or if the claims are proven obvious, invalidation is possible. However, detailed structural definitions act as robust barriers.


Key Takeaways

  • Claim Breadth: The patent’s claims robustly cover a specific chemical structure, its formulations, and therapeutic methods, yet maintain some scope for derivatives.
  • Strategic Position: It extends the applicant’s patent portfolio in CNS therapeutics, likely creating a strong market position.
  • Patent Landscape: It builds upon earlier patents, with a focus on refining and broadening chemical and formulation coverage.
  • Enforcement Potential: Multiple claim types facilitate aggressive licensing and infringement actions.
  • Vulnerabilities: Similar compounds with minor structural variations or alternative formulations could challenge validity or enable design-around strategies.

References

[1] United States Patent and Trademark Office (USPTO). Patent No. 11,786,487. Available at USPTO official database.

[2] USPTO Patent Application Publications. Relevant prior art from 2015-2022.

[3] Industry Reports on CNS-targeted pharmaceuticals, 2022.

[4] WIPO (World Intellectual Property Organization). Patent landscape analyses for CNS drug technologies, 2021.

[5] FDA Approved Drugs List. Analyzed similarities and differences in chemical classes.


More… ↓

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Drugs Protected by US Patent 11,786,487

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ucb Inc FINTEPLA fenfluramine hydrochloride SOLUTION;ORAL 212102-001 Jun 25, 2020 RX Yes Yes 11,786,487*PED ⤷  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 11,786,487

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017315273 ⤷  Start Trial
Australia 2021204250 ⤷  Start Trial
Australia 2022279469 ⤷  Start Trial
Canada 3032996 ⤷  Start Trial
China 109689103 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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