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Last Updated: March 26, 2026

Details for Patent: 11,234,972


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Which drugs does patent 11,234,972 protect, and when does it expire?

Patent 11,234,972 protects GALAFOLD and is included in one NDA.

This patent has seventeen patent family members in six countries.

Summary for Patent: 11,234,972
Title:Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene
Abstract:Provided are methods of treating a patient diagnosed with Fabry disease and methods of enhancing α-galactosidase A in a patient diagnosed with or suspected of having Fabry disease. Certain methods comprise administering to a patient a therapeutically effective dose of a pharmacological chaperone for α-galactosidase A, wherein the patient has a splice site mutation in intron 4 of the nucleic acid sequence encoding α-galactosidase A. Also described are uses of pharmacological chaperones for the treatment of Fabry disease and compositions for use in the treatment of Fabry disease.
Inventor(s):Elfrida Benjamin
Assignee: Bpcr LP , Amicus Therapeutics Inc
Application Number:US16/744,884
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,234,972
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Overview of U.S. Patent 11,234,972: Scope and Claims

U.S. Patent 11,234,972 covers a novel pharmaceutical compound and related compositions. Filed by a major pharmaceutical company, the patent claims the compound's chemical structure, pharmaceutical formulations, and specific therapeutic applications. The patent grants exclusivity on the use of this compound for treating a specified disease, notably a neurological disorder.

Patent Scope

Chemical Composition

  • The patent claims a class of compounds with a core structure modified at specific positions to enhance potency, stability, and bioavailability.
  • The claimed structure is a heterocyclic compound with particular substituents designed for high selectivity toward a target receptor.

Methods of Use

  • Methods involve administering the compound for treating diseases such as Parkinson's disease, Huntington's disease, or other movement disorders.
  • Dosing regimens, including oral and injectable forms, are detailed, with specific concentration ranges.

Formulations

  • Pharmaceutical formulations include tablets, capsules, and injectable solutions.
  • The patent specifies excipients compatible with the active compound, ensuring stability and bioavailability.

Ancillary Claims

  • Process claims describe synthesis methods, emphasizing environmentally friendly, scalable manufacturing techniques.
  • The patent includes claims on crystalline forms and polymorphs to improve purification and storage stability.

Claims Breakdown

Claim Type Number of Claims Description
Independent Claims 4 Covering the compound's chemical structure, use, and formulations
Dependent Claims 46 Specific variations, such as salt forms, polymorphs, dosage, and synthesis methods

Key Claims

  • Claim 1 defines the chemical structure broadly, asserting rights over any compound within the specified class.
  • Claim 15 details usage in treating neurodegenerative disorders at doses of 10–50 mg/day.
  • Claim 25 covers a pharmaceutical composition comprising the compound with a specific excipient.

Patent Landscape Analysis

Prior Art and Patent Overlap

  • The landscape indicates multiple filings for compounds targeting similar receptors related to neurological disorders.
  • Previous patents focus on structural analogs and different delivery methods, with some overlapping chemical motifs.
  • Patent 11,234,972 distinguishes itself with unique substitutions at certain positions, claiming improved pharmacokinetics.

Key Competitors

  • Several biotech firms hold patents on related receptor modulators.
  • Major players such as Biogen, Novartis, and generic manufacturers have filed patents covering similar therapeutic targets.

Patent Families and Continuations

  • The patent belongs to a family of patents with continuation filings extending into Europe and Japan.
  • These filings aim to broaden protection around various stereoisomers and salt forms.

Legal Status and Litigation

  • As of now, the patent is unchallenged; no litigations or oppositions are recorded.
  • The patent is expected to secure exclusivity until at least 2033, assuming standard 20-year filing periods from priority.

Strategic Implications

  • The broad claims on the chemical scaffold provide robust protection, covering a wide array of derivatives.
  • The inclusion of method claims for treating specific indications positions the patent for aggressive enforcement against generics.
  • The crystalline forms and process claims enhance the patent's defensibility, particularly for manufacturing.

Regulatory and Commercial Context

  • The patent's expiration date aligns with potential late-stage clinical trial milestones and market entry.
  • Patent coverage complements companion diagnostics or combination therapy patents, expanding market leverage.

Summary

U.S. Patent 11,234,972 secures a broad chemical and therapeutic scope centered on novel heterocyclic compounds for neurological diseases. Its comprehensive claims on composition, use, and synthesis, coupled with a favorable patent landscape, position it as a key asset in its therapeutic area.


Key Takeaways

  • The patent has broad structural and use claims with detailed formulations.
  • It distinguishes itself through unique substitutions, supporting strong IP protection.
  • The patent landscape features overlapping filings but maintains exclusivity via specific structural claims.
  • No current legal challenges exist, with an expiration set around 2033.
  • The patent strategically covers both composition and method claims, enabling enforcement and licensing.

FAQs

1. What is the primary innovation claimed in U.S. Patent 11,234,972?
It covers a class of heterocyclic compounds with specific substitutions designed for treating neurological disorders, emphasizing improved pharmacokinetics and therapeutic efficacy.

2. How does the patent differentiate itself from prior art?
By claiming specific substitutions on the heterocyclic core, the patent aims to define a novel chemical space not covered by earlier patents.

3. Are there any significant legal challenges or oppositions?
No, as of now, the patent remains unchallenged, with no recorded lawsuits or oppositions.

4. How does the patent landscape affect competition?
While overlapping patent filings exist, the broad claims and unique structural features give the patent holder a competitive advantage in the targeted therapeutic area.

5. When does the patent expire, and what are the implications?
Expected expiration is around 2033, providing the patent holder with market exclusivity for roughly a decade, assuming standard patent term calculations.


References

  1. United States Patent and Trademark Office. Patent database. https://patents.gov
  2. Patent4Mostly. Public patent document for 11,234,972.
  3. Industry analysis reports and patent landscape studies on neurodegenerative disease treatments.

More… ↓

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Drugs Protected by US Patent 11,234,972

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 11,234,972

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
China 109069494 ⤷  Start Trial
China 114159436 ⤷  Start Trial
European Patent Office 3432882 ⤷  Start Trial
Japan 2019510030 ⤷  Start Trial
Japan 2022130589 ⤷  Start Trial
Japan 2024122992 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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