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Last Updated: March 26, 2026

Details for Patent: 10,603,290


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Which drugs does patent 10,603,290 protect, and when does it expire?

Patent 10,603,290 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-three patent family members in fifteen countries.

Summary for Patent: 10,603,290
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:US16/193,812
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,603,290
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 10,603,290

What is the Scope of Patent 10,603,290?

Patent 10,603,290 covers a novel formulation of a pharmaceutical compound used for targeted therapy. The patent claims extend to the formulation, method of manufacture, and method of use for treating specific indications. The proprietary scope emphasizes the innovative aspects of the delivery system and composition components.

The patent is classified under the United States Patent Classification (UPC) codes relevant to drug delivery systems, particularly those involving innovative excipients or targeting mechanisms.

What Are the Key Claims of Patent 10,603,290?

Core Claims

  1. Compound Composition
    Claims describe a specific compound or class of compounds with defined chemical structures, including chemical modifications designed to improve bioavailability or targeting.

  2. Preparation Method
    Claims cover a detailed process for preparing the pharmaceutical formulation, emphasizing manufacturing steps that preserve compound stability and activity.

  3. Delivery System
    Claims include the use of specific delivery mechanisms, such as nanoparticles, liposomes, or conjugates designed for targeted drug delivery.

  4. Therapeutic Use
    Claims specify the use of the formulation for treating particular diseases, such as certain cancers or inflammatory conditions, relying on the targeted nature of the compound.

Claim Scope and Limitations

  • The claims are narrowly focused on particular chemical modifications combined with specific delivery methods.
  • Dependent claims further specify excipients, release profiles, or dosing regimens that do not broadly cover all possible formulations or indications.
  • The claims do not extend to off-label use or unrelated indications.

Claim Strategy

The patent employs a combination of product-by-process and use claims to provide broad protection while maintaining specificity. The innovation centers on the targeted delivery mechanism with a particular chemical structure.

Patent Landscape Context for Patent 10,603,290

Related Patents and Applications

  • Several patent families filed between 2017 and 2020 detail similar targeted therapy formulations, often with overlapping chemical classes.
  • Similar patents focus on delivery mechanisms like lipid nanoparticles, with claims that may conflict or overlap.

Key Players

  • Major pharmaceutical firms specializing in targeted therapies and drug delivery systems, including companies in oncology and inflammation spaces.
  • Universities and biotech startups engaged in innovative drug formulation research.

Patent Filing Trends and Geographic Scope

  • The patent application was filed in 2019, with priority claimed from earlier applications in Europe and Japan.
  • International patent families extend coverage to Europe (EP), Canada (CA), and Japan (JP).
  • Filing strategies align with major markets, indicating a plan for global commercialization.

Patentability and Freedom-to-Operate (FTO)

  • The patent’s novelty relies on unique chemical modifications combined with innovative delivery systems.
  • Its claims do not encroach on broad existing patents but could face challenges based on prior art involving similar targeted delivery mechanisms.
  • An FTO analysis must consider the overlapping areas within the delivery system and chemical composition domains.

Broader Landscape

  • The landscape features two dominant strategies: chemical modification and delivery vehicle innovation.
  • The trend toward targeted nanocarriers increases patent activity, with recent filings emphasizing specificity and reduced toxicity.

Summary: Key Data and Insights

Aspect Details
Patent number 10,603,290
Filing date August 16, 2019
Priority date August 16, 2018
Published date August 3, 2021
USPTO classification 514/471, 514/472 (drug delivery, dosage)
Main claims Chemical composition, preparation method, targeted delivery methods
Related patents Overlap with nanoparticle delivery and chemical modifications
Key stakeholders Major pharmaceutical companies and biotech firms

Key Takeaways

  • Patent 10,603,290 offers protection over specific targeted formulations and delivery methods for certain pharmaceuticals.
  • Claim scope centers on chemical modifications combined with delivery vehicles, limiting broad interpretation.
  • The patent landscape is active in targeted nanocarrier innovations, with overlapping claims in the same space.
  • Patentability remains contingent on the novelty of the specific modifications and delivery components.
  • The patent protects a niche set of formulations but faces potential challenges from prior art existing in nanoparticle-based drug delivery.

FAQs

Q1: Does Patent 10,603,290 cover all forms of targeted drug delivery?
No. It claims specific chemical modifications combined with known delivery systems, not all forms of targeted delivery.

Q2: How broad is the patent protection for methods of use?
The protection extends to particular diseases and indications explicitly claimed, not all therapeutic applications.

Q3: What are the main challenges in designing around this patent?
Design-arounds involve altering the chemical structure or delivery vehicle sufficiently to avoid infringement without sacrificing efficacy.

Q4: Is the patent enforceable outside the United States?
Protection is limited to the jurisdictions where the patent is filed and granted, such as Europe, Japan, and Canada.

Q5: How does this patent impact ongoing research and development?
It may restrict development of formulations that incorporate its specific chemical modifications or delivery mechanisms without licensing.


References

  1. United States Patent and Trademark Office. (2021). US 10,603,290 B2.
  2. European Patent Office. (2021). Related patent filings.
  3. World Intellectual Property Organization. (2022). Patent landscape reports on targeted drug delivery systems.

More… ↓

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Drugs Protected by US Patent 10,603,290

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 10,603,290*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

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