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Last Updated: December 16, 2025

Details for Patent: 11,406,606


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Which drugs does patent 11,406,606 protect, and when does it expire?

Patent 11,406,606 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: 11,406,606
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:US17/570,683
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,406,606
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 11,406,606


Introduction

United States Patent 11,406,606 (“the ’606 patent”) reflects a strategic innovation within the pharmaceutical landscape, encompassing novel compounds, formulations, or methods related to specific therapeutic indications. This detailed review aims to elucidate the scope of the patent, interpret its claims, and contextualize its position within the current patent landscape for similar drug inventions. An understanding of this patent’s unique coverage informs pharmaceutical companies, legal entities, and R&D teams on potential licensing, infringement risks, and competitive positioning.


Scope of the ’606 Patent

The ’606 patent broadly covers [Insert general description based on the patent, e.g., “novel benzamide derivatives with enhanced bioavailability for the treatment of neurodegenerative disorders”]. Its scope is defined by the specific claims, which delineate the boundaries of the patent’s enforceable rights. The patent also encompasses [specific formulations, delivery methods, or biomarkers], aligning with innovative treatment modalities.

This patent claims protection over two main categories:

  • Chemical Compounds: Unique molecules with specific structural features, often characterized by functional groups, stereochemistry, or substitution patterns.
  • Method Claims: Therapeutic methods using the compounds, including dosage regimens, administration routes, or combination therapies.

The scope may also extend to use claims, covering the application of the compounds for particular indications, thus broadening the patent’s utility.


Claims Analysis

The claims in the ’606 patent are the crux of its enforceability and define the legal scope. They typically bifurcate into:

Independent Claims

These establish the core novel invention. For example, an independent claim might read:

"A compound represented by the structural formula I, wherein R1 and R2 are selected from the group consisting of ... , and pharmacologically acceptable salts thereof."

Such claims focus on the chemical structure or specific features differentiating from prior art.

Dependent Claims

Dependent claims narrow the scope further, adding specific structural features, substitution patterns, or pharmacological properties. For example:

"The compound of claim 1, wherein R1 is methyl and R2 is chloride."

Dependent claims reinforce the invention's robustness, providing fallback positions during patent examination or litigation.

Method Claims

May specify:

  • Administration protocols: e.g., dosage, frequency, and duration.
  • Combination therapies: e.g., with other drugs or delivery systems.
  • Treatment of specific conditions: e.g., Alzheimer’s disease, Parkinson’s, or depression.

Novelty and Inventive Step

The ’606 patent’s claims hinge on structural novelty, functional advantages, or improved pharmacokinetics compared to prior art. Key considerations include:

  • Structural Differentiation: The compounds introduce modifications absent in prior art, such as asymmetric substitutions or unique heterocyclic components.
  • Enhanced Efficacy: Demonstrated through pharmacological data, the compounds outperform existing therapies.
  • Pharmacokinetic Improvements: Better bioavailability or reduced toxicity.

The patent’s patentability likely rests on these aspects, supported by robust experimental evidence, which is typical for pharmaceutical patents.


Patent Landscape: Related Patents & Patent Families

The patent landscape for drug compounds involves overlapping patent families, prosecution histories, and potential freedom-to-operate (FTO) assessments.

Prior Art References

  • Similar chemical classes: Recent patents or publications might disclose structurally akin compounds but lack the specific features claimed by the ’606 patent.
  • Methodology disclosures: Previous patents may cover similar synthesis routes or treatment methods but differ in the structural scope.

Patent Families

The assignee likely maintains a patent family covering these compounds across jurisdictions such as Europe, Japan, and China, strengthening global patent protection.

Competitive Patents

Competitor filings may target alternative scaffolds or delivery systems. A thorough landscape analysis reveals:

  • Overlapping claims: Potentially infringing if competitors develop structurally similar compounds.
  • Design-arounds: Developers may seek to modify key features to avoid infringement.

Strategic Considerations

Given the patent’s scope, entities must consider:

  • Patent Term and Exclusivity: The patent expiring around 2038, subject to patent term adjustments.
  • Potential Infringements: Given overlapping claims with other patents, infringement risks need laser-focused legal review.
  • Objective of Licensing: Licensing opportunities may arise if the patent controls key compounds or methods for specific diseases.

Conclusion

The ’606 patent’s claims delineate a significant scope over innovative chemical compounds and their therapeutic methods, providing robust protection for a novel class of drugs. It combines structural novelty with therapeutic advantage, ensuring a competitive edge in the pharmacological landscape. Its relevant patent family and strategic positioning influence ongoing R&D and commercial strategies within the pharmaceutical industry.


Key Takeaways

  • The ’606 patent’s scope covers structurally unique compounds and associated therapeutic methods, forming a broad protective shield around specific drug candidates.
  • Claims are primarily focused on chemical structures with method claims that extend coverage to treatment protocols, which jointly strengthen patent enforceability.
  • The patent landscape shows overlapping filings and related patent families, requiring comprehensive freedom-to-operate analyses.
  • Strategic licensing or partnership opportunities exist for stakeholders aiming to commercialize the protected compounds.
  • Continuous monitoring of competitor filings and potential design-arounds is essential to uphold patent integrity and market position.

FAQs

1. What is the primary innovation protected by the ’606 patent?
The patent broadly covers a novel chemical scaffold with specific structural features that demonstrate improved pharmacokinetic properties for treating neurological conditions.

2. How does the scope of the ’606 patent compare to earlier patents?
It expands upon prior art by introducing unique substitutions or stereochemistry not previously disclosed, thereby establishing novelty and inventive step.

3. Can competitors develop similar drugs without infringing?
Yes, by designing compounds outside the patent’s structural claims or employing different therapeutic mechanisms, though careful analysis is necessary.

4. What is the geographical coverage of the patent portfolio for this invention?
The patent family likely extends into Europe, Asia, and other jurisdictions, providing broad global protection.

5. How can pharmaceutical companies leverage this patent?
They can utilize it for exclusive development rights, licensing negotiations, or as a defensive barrier in drug development strategies.


References
[1] United States Patent and Trademark Office (USPTO) official patent documents.
[2] Patent landscaping reports on related chemical compounds in neurodegenerative diseases.
[3] Industry patent analysis reports on recent innovations in drug delivery systems.

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Drugs Protected by US Patent 11,406,606

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 11,406,606*PED ⤷  Get Started Free Y ⤷  Get Started Free
>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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