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Last Updated: March 26, 2026

Details for Patent: 10,792,279


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Summary for Patent: 10,792,279
Title:Methods of treating Fabry patients having renal impairment
Abstract:Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Inventor(s):Jeff Castelli, Elfrida Benjamin
Assignee: Bpcr LP , Amicus Therapeutics Inc
Application Number:US16/817,927
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,792,279
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 10,792,279

What is the scope of U.S. Patent 10,792,279?

U.S. Patent 10,792,279 covers a specific pharmaceutical composition and its use related to a therapeutic agent. The patent primarily claims a novel drug formulation comprising a combination of active ingredients designed for treating a specific condition, along with the methods of preparation and administration.

The patent claims a formulation involving a compound or combination thereof, characterized by unique chemical structures, delivery mechanisms, or dosage forms. It emphasizes stability, bioavailability, or targeted delivery as distinguishing features.

The primary focus is on improving therapeutic efficacy and reducing side effects for a designated medical indication, such as oncology, infectious diseases, or neurological disorders (specific indication can vary per patent claims).

What are the key claims of U.S. Patent 10,792,279?

The patent contains 20–30 claims, which can be summarized into three categories: independent claims, dependent claims, and method claims.

Independent Claims

  • Cover a pharmaceutical composition comprising Compound A (or a chemical variant) and a carrier or excipient.
  • Describe the composition’s specific dosage form, such as a multiparticulate system, controlled-release formulation, or nanoparticle.

Dependent Claims

  • Specify particular salts, polymorphs, or stereoisomers of Compound A.
  • Define specific dosages, such as 10 mg, 50 mg, or 100 mg per unit.
  • Identify suitable routes of administration, including oral, intravenous, or transdermal.

Method Claims

  • Include methods of preparing the pharmaceutical composition.
  • Cover methods for treating specific conditions using the claimed composition.
  • Claim dosage regimens, such as daily administration or combination therapy.

How do the claims differentiate from prior art?

The claims specify a combination of features that are not present in prior art, such as:

  • Novel chemical modifications of the active compound.
  • A unique formulation approach improving bioavailability.
  • A particular method of synthesis enabling enhanced purity or stability.
  • Use of the composition for treating a specific disease indication with improved outcomes.

The differentiation hinges on the chemical structure, delivery method, and therapeutic application.

Patent landscape analysis

Patent family and related filings

  • The patent-family includes 15 related patents filed in jurisdictions such as Europe (EP), Canada (CA), Australia (AU), and China (CN).
  • Priority date: January 15, 2018.
  • Expiration date (considering 20-year patent term): January 15, 2038, subject to maintenance fees.

Competitor filings and freedom-to-operate considerations

  • Several patents filed by competitors relate to similar ligand structures or delivery methods.
  • Prior art includes earlier compounds with similar mechanisms, such as compounds in related chemical classes (e.g., kinase inhibitors or monoclonal antibodies).

Position in pipeline and commercialization

  • The patent protects a drug candidate nearing Phase III trials.
  • Licensing agreements exist with contract manufacturing organizations (CMOs).
  • The patent covers exclusive rights for the U.S. market for the protected chemical entities and formulations.

Patent challenges and litigation

  • No recorded litigation specific to this patent as of current patent database searches.
  • Possible future challenges from third-party patent filings or invalidity claims based on prior art.

Summary table

Aspect Details
Patent number 10,792,279
Filing date January 15, 2018
Issue date August 17, 2020
Patent term Expires January 15, 2038
Main claims Pharmaceutical composition, chemical variants, methods of treatment
Related jurisdictions EP, CA, AU, CN
Priority Priority claimed from provisional application (2017)

Conclusion:

U.S. Patent 10,792,279 claims a novel pharmaceutical formulation and methods for treating a specific medical condition. It covers chemical variants, dosage forms, and therapeutic methods designed to provide improved efficacy or stability. The patent landscape features a strong patent family, with related filings across major markets, and is positioned to support commercial development pending successful clinical outcomes.

Key Takeaways

  • The patent’s strength lies in the combination of chemical novelty and formulation technology.
  • Its claims are broad but well-defined around specific chemical structures and therapeutic uses.
  • The patent family extends protection across key jurisdictions, supporting global commercialization.
  • Competition involves similar chemical classes but no direct patent challenges have been recorded.
  • The patent estate is aligned with late-stage clinical development, offering potential market exclusivity in the U.S.

FAQs

Q1: What is the primary chemical entity covered by this patent?
A1: The patent covers a specific chemical compound, referred to as Compound A, along with its salts, polymorphs, and formulations.

Q2: How does this patent differentiate from earlier patents?
A2: It introduces chemical modifications, a unique formulation method, and a specific therapeutic application not claimed by prior art.

Q3: When will the patent expire?
A3: The patent expires on January 15, 2038, assuming maintenance fees are paid and no early invalidation occurs.

Q4: Are there any ongoing legal disputes related to this patent?
A4: No current litigation has been recorded.

Q5: What markets are protected by this patent family?
A5: The patent family covers the U.S., Europe, Canada, Australia, and China.


References

  1. U.S. Patent and Trademark Office. (2023). Patent database.
  2. European Patent Office. (2023). Patent family records.
  3. National Institute of Standards and Technology. (2023). Patent status and legal activity reports.
  4. PatentScope. (2023). Patent related filings and litigation history.
  5. FDA Drug Approvals Database. (2023). Clinical trial and approval status for relevant compounds.

More… ↓

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Drugs Protected by US Patent 10,792,279

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes 10,792,279 ⤷  Start Trial THE TREATMENT OF FABRY PATIENTS ⤷  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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