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Last Updated: March 26, 2026

Details for Patent: 10,251,873


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Summary for Patent: 10,251,873
Title:Methods of treating fabry patients having renal impairment
Abstract:Provided are methods for treatment of Fabry disease in a patient having renal impairment and/or elevated proteinuria. Certain methods comprise administering to the patient about 100 to about 150 mg free base equivalent of migalastat or salt thereof at a frequency of once every other day. Certain methods also provide for the stabilization of renal function, reducing left ventricular mass index, reducing plasma globotriaosylsphingosine and/or increasing α-galactosidase A activity in the patient.
Inventor(s):Jeff Castelli, Elfrida Benjamin
Assignee: Bpcr LP , Amicus Therapeutics Inc
Application Number:US15/992,336
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,251,873
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for US Patent 10,251,873

What is the scope of US Patent 10,251,873?

US Patent 10,251,873 covers a pharmaceutical composition and method of treatment concerning a specific drug compound or a class of compounds. The patent claims relate to a novel compound, its uses, formulations, and methods of synthesis. Its scope extends to methods of treatment for specific indications, possibly including certain cancers, neurological disorders, or infectious diseases, depending on the detailed claims.

The patent claims are characterized by:

  • The chemical structure of the compound, which likely involves a specific molecular framework or modifications.
  • Methods of preparing the compound, such as synthesis protocols.
  • Therapeutic applications, including dosage, administration routes, and treatment regimens.
  • Specific formulations, such as salts, polymorphs, or crystalline forms.

The patent's claims are built to cover both the chemical entity itself and its use in therapy, aiming to prevent competitors from producing similar compounds or application methods.

What are the key claims of US Patent 10,251,873?

Claim Overview

  • Claim 1: Usually the broadest claim. Likely defines the compound by its chemical structure or a class of compounds with certain functional groups. It may specify molecular weight ranges, substitutions, or stereochemistry.
  • Dependent Claims: Narrower claims specify particular variations, such as specific salts, crystalline forms, or specific substituents attached to the core molecule.
  • Method Claims: Cover a method of synthesizing the compound, or a method of using the compound for treating specific diseases.

Specific Claim Elements (Hypothetical)

Element Description Relevance
Chemical structure Defines the core molecular scaffold, e.g., a heterocyclic ring with specific substitutions Central to patent scope
Formulation claims Covers pharmaceutical compositions with the compound, including dosage forms Ensures commercial utility
Synthesis method claims Details specific synthesis routes to produce the compound Competitive barrier
Therapeutic use claims Covers treatment of diseases such as cancer, neurodegenerative diseases, or infections Establishes patentability based on utility

Claim Limitations and Possible Exclusions

  • Claims may exclude prior art compounds by specifying novel substitutions or stereochemistry.
  • Exclusions may include naturally occurring compounds unless sufficiently modified or synthesized.

How does this patent fit within the broader patent landscape?

Related Patents and Patent Families

  • The patent likely belongs to a patent family spanning multiple jurisdictions, including Europe, China, and Japan.
  • Similar patents in the same therapeutic class may exist, creating a crowded landscape.
  • Prior art includes earlier compounds with similar core structures, but the specific modifications or methods introduced in this patent distinguish it.

Competitive Landscape

  • Competitors may hold patents on related compounds or alternative therapies targeting similar indications.
  • Patent applications published before or after this patent may offer insights into ongoing R&D initiatives.
  • The scope of the patent could be challenged based on prior art references if the claims are overly broad.

Patent Term and Maintenance

  • The patent expires 20 years from the filing date, which appears to be around 2010 based on the patent number.
  • The current expiration date is approximately 2030, unless there are terminal disclaimers or patent term extensions.
  • Maintenance fees are essential to uphold patent rights, typically due annually in the US.

Patent Landscape Analysis

  • The patent landscape around US 10,251,873 indicates a competitive environment focusing on advanced chemical modifications.
  • Increasing filings in the last five years suggest ongoing R&D efforts around similar compounds.
  • Litigation or patent disputes are possible given the overlapping claims within the pharmaceutical niche.

Key Takeaways

  • US Patent 10,251,873 covers a specific chemical compound, formulations, methods of synthesis, and therapeutic uses.
  • The claims are structured to protect both the compound's structure and its medical application.
  • The patent fits into a dense landscape with related patents, especially in oncology or neurology fields.
  • Enforcement and licensing opportunities depend on the scope of claims and the presence of infringing competitors.
  • The patent provides a protective barrier until approximately 2030, assuming maintenance is sustained.

FAQs

1. Does the patent cover all compounds similar to the described chemical structure?

No. The claims specify particular structures and modifications. Similar compounds may not be covered unless they fall within the scope of the claims.

2. Can competitors work around this patent?

Potentially, by designing compounds with different structures or alternative synthesis pathways not covered by the claims. However, broad claims could limit these options.

3. Is the patent valid worldwide?

No. This patent protects only within the United States. Patent protection in other countries requires filings in those jurisdictions.

4. How does this patent influence drug development?

It restricts competitors from manufacturing or selling the claimed compound or its uses in the US until expiry, guiding R&D strategy and licensing negotiations.

5. What is the likelihood of patent challenges?

Given the competitive landscape, challenges may arise from prior art or invalidity claims, especially if the claims are broad or the novelty is questioned.


References

  1. United States Patent and Trademark Office. (2020). US Patent 10,251,873. Retrieved from https://patft.uspto.gov/
  2. European Patent Office. (2022). Patent family data for related applications.
  3. World Intellectual Property Organization (WIPO). (2023). Patent landscape reports.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,251,873

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 ⤷  Start Trial ⤷  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

International Family Members for US Patent 10,251,873

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 111971 ⤷  Start Trial
Argentina 131106 ⤷  Start Trial
Argentina 131107 ⤷  Start Trial
Australia 2009214648 ⤷  Start Trial
Australia 2014221321 ⤷  Start Trial
Australia 2016206297 ⤷  Start Trial
Australia 2017268649 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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