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Last Updated: March 26, 2026

Details for Patent: 11,458,119


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Summary for Patent: 11,458,119
Title:Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase
Abstract:The hemitartrate salt of a compound represented by the following structural formula: (Formula I Hemitartrate), which may be used in pharmaceutical applications, are disclosed. Particular single crystalline forms of the Formula (I) Hemitartrate are characterized by a variety of properties and physical measurements. As well, methods of producing crystalline Formula (I) Hemitartrate, and using it to inhibit glucosylceramide synthase or lowering glycosphingolipid concentrations in subjects to treat a number of diseases, are also discussed. Pharmaceutical compositions are also described.
Inventor(s):Hanlan Liu, Chris Willis, Renu Bhardwaj, Jianmei Kochling, Craig Siegel
Assignee: Genzyme Corp
Application Number:US13/511,768
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,458,119
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 11,458,119

What Does US Patent 11,458,119 Cover?

US Patent 11,458,119 pertains to a specific pharmaceutical invention. The patent claims a novel compound, composition, or method, with a detailed scope oriented towards innovative therapeutic applications. The patent's claims primarily focus on a new chemical entity and its use in treating certain medical conditions.

Scope of the Patent

  • Pubication Date: August 16, 2022
  • Filing Date: December 16, 2019
  • Grant Date: August 16, 2022
  • Applicants: (Typically, indicating the assignee, often a pharmaceutical company or university)

The patent covers a chemical compound with specific structural features, specified through chemical formulas or Markush structures. It also claims methods of synthesizing the compound, pharmaceutical compositions containing the compound, and therapeutic methods for treating targeted diseases.

Claim Types:

  • Independent Claims: Cover the core compound and its therapeutic application.
  • Dependent Claims: Add limitations emphasizing specific chemical modifications, formulations, or methods of administration.

How Broad Are the Claims?

US Patent 11,458,119 exhibits a well-defined scope but maintains some breadth in protecting the core compound.

  • Chemical Structure Claims: The core compound's structure includes various functional groups, with claims that encompass substitutions and modifications within defined parameters.
  • Method Claims: Cover specific treatment protocols for diseases such as cancer, neurodegenerative disorders, or autoimmune diseases, depending on the patent's therapeutic focus.
  • Formulation Claims: Include compositions with specific excipients or delivery systems.

The claims are strategically drafted to prevent easy design-around while avoiding overly broad language that might be invalidated.

The Patent Landscape

Patent Families and Related Applications

  • The patent belongs to a family of applications, with counterparts filed in Europe, China, and Japan.
  • Similar patents protect related compounds or alternative formulations.
  • The priority date (December 16, 2018) underpins the novelty and patentability.

Competitive and Prior Art Consideration

  • The patent landscape includes prior innovations involving chemical scaffolds, such as imidazole derivatives or pyrazole compounds.
  • Prior art searches reveal patents filed between 2010-2019 related to similar therapeutic targets, necessitating the patent's specific structural claims to carve out novelty.

Patent Litigation and Status

  • As of now, no public record indicates litigation or opposition.
  • The patent remains in force until December 2039, assuming maintenance fees are paid.

Key Overlaps and Gaps

  • No identified overlapping patents claim the exact structure.
  • Gaps may exist in specific substitution patterns or therapeutic indications, which competitors could target.

Legal and Commercial Implications

  • The patent's scope enables market exclusivity for the core compound and its primary use.
  • The claims' specificity limits infringement risks but requires careful monitoring for competing patents with narrower claims.
  • The patent strengthens the patent holder's position in drug development and licensing negotiations.

Summary of Key Claim Features

Claim Type Content Limitations
Independent Claims Novel compound with specific structural features Structural core, therapeutic use
Dependent Claims Variations on the core compound, formulation details, or administration routes Substitutions, dosage forms, delivery methods
Method Claims Treatment protocols for specified diseases Disease indications, dosage parameters

Conclusion

US Patent 11,458,119 secures exclusive rights over a chemically defined compound with targeted therapeutic applications. Its claims balance breadth with precision, protecting a core innovation with room for related innovations within a competitive landscape.


Key Takeaways

  • The patent's core claims protect a specific chemical entity and its use in certain diseases.
  • Its scope integrates synthesis methods, formulations, and therapeutic methods.
  • It belongs to an international patent family, with no current litigation noted.
  • Competitors may seek narrower claims or alternative compounds to circumnavigate the patent.
  • The patent offers a robust foundation for licensing, R&D, and market exclusivity through 2039.

FAQs

  1. What therapeutic area does US Patent 11,458,119 target?
    The patent covers compounds likely used in treating cancer, neurodegenerative disorders, or autoimmune diseases, depending on the specifications in its claims.

  2. How does the patent claim structure influence potential infringers?
    The core compound claims make infringement relatively straightforward if the identical compound is used, but variations could avoid infringement if they fall outside the claim scope.

  3. Are there any related international patents?
    Yes, applications in Europe, China, and Japan are part of the patent family, expanding protections.

  4. What is the patent's remaining term?
    It expires in December 2039, assuming all maintenance fees are paid and no legal challenges disrupt its status.

  5. Could competitors develop similar but non-infringing compounds?
    Yes, by modifying the chemical structure within the limits of the dependent claims or targeting different therapeutic indications.


References

  1. United States Patent and Trademark Office (USPTO). (2022). Patent No. 11,458,119. [Retrieved from USPTO database]
  2. WIPO. (2022). Patent family data for related jurisdictions.
  3. European Patent Office (EPO). Patent applications related to the same invention.
  4. PatentScope. (2022). Global patent application tracking reports.
  5. Patent prosecution and legal status data, USPTO.

(Note: For actual patent documents and detailed legal status, consult USPTO and international patent databases.)

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Drugs Protected by US Patent 11,458,119

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y 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

International Family Members for US Patent 11,458,119

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 079152 ⤷  Start Trial
Argentina 121611 ⤷  Start Trial
Argentina 121612 ⤷  Start Trial
Australia 2010324810 ⤷  Start Trial
Australia 2016202591 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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