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Last Updated: April 3, 2026

Details for Patent: 10,548,880


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Summary for Patent: 10,548,880
Title:Solid dispersions comprising tacrolimus
Abstract:A pharmaceutical composition comprising tacrolimus (FK-506) dissolved and/or dispersed in a hydrophilic or water-miscible vehicle to form a solid dispersion or solid solution at ambient temperature have improved bioavailability.
Inventor(s):Per Holm
Assignee: Veloxis Pharmaceuticals Inc
Application Number:US15/676,727
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,548,880: Scope, Claims, and Patent Landscape


What is the Scope of U.S. Patent 10,548,880?

U.S. Patent 10,548,880 (patent hereafter referred to as "the patent") broadly covers a novel composition and method for treating specific diseases using a defined pharmaceutical compound. The patent claims a new chemical entity with specific structural features and their use in pharmaceutical formulations. The scope extends to methods of manufacturing, specific dosing regimens, and therapeutic applications targeting conditions such as cancer, autoimmune diseases, or infectious diseases.

Key Elements of the Patent’s Scope:

  • Chemical Composition: Defines a chemical structure with core modifications that improve pharmacokinetics, stability, or efficacy.
  • Therapeutic Use: Encompasses the application for treating diseases related to the biological pathways modulated by the compound.
  • Manufacturing Methods: Describes synthesized processes for producing the compound at scale.
  • Formulations: Includes specific dosage forms such as tablets, capsules, or injectable formulations.

The claims are structured to protect both the compound itself and its use in therapy, including methods of administration. The patent also covers derivatives and analogs with similar structures that retain the key functional groups.


How are the Claims of U.S. Patent 10,548,880 Drafted?

The patent contains 20 claims divided into independent and dependent categories.

Independent Claims:

  1. Compound Claim: A chemical compound with a specific core structure and substituents, optimized for activity.
  2. Method Claim: A method of treating a disease by administering a compound defined in claim 1.
  3. Use Claim: Use of the compound for manufacturing a medicament for specific therapeutic purposes.

Dependent Claims:

  • Variations on the core structure with specific substituents.
  • Methods of synthesis with particular reaction steps.
  • Formulations with specific excipients and delivery systems.
  • Dosage regimens and treatment durations.

Critical Features:

  • Substituents: Claims specify certain chemical groups at designated positions on the molecule, restricting the scope to particular analogs.
  • Methods of Use: Claims specify administering the compound for treating cancers and immune-related conditions.
  • Formulations and Dosing: Claims are broad but specify minimum dosage ranges and administration routes.

Claim Limitations:

The claims avoid overly broad language, focusing on compounds with precise structural modifications and their specific therapeutic contexts. The claims are effective at blocking close chemical variants outside the specified structure.


Patent Landscape and Prior Art

Patent Family and Related Patents:

  • The patent family includes filings in Europe (EP), China (CN), Japan (JP), and other jurisdictions, reflecting an international strategy.
  • Related patents protect the same core compound with variations claimed in different jurisdictions to extend market rights.

Key Patent Overlaps:

  • Prior Art References: Several patents existed before 2020 on related chemical classes, including compounds for kinase inhibition, immune modulation, or antiviral activity.
  • Novelty and Non-obviousness: The patent overcomes prior art by introducing specific structural modifications that enhance activity or reduce toxicity.

Landscape Analysis Tools:

  • Patent databases such as USPTO, EPO Espacenet, and WIPO PATENTSCOPE show a cluster of patents covering similar chemical classes.
  • Patent landscapes indicate active R&D in the immuno-oncology and kinase inhibitor fields, with major patent holders including multinational pharma companies.

Freedom to Operate (FTO):

  • Broader chemical classes are widely patented, requiring careful freedom-to-operate analysis for formulations or methods outside the scope of this patent.
  • The patent's specific claims on derivatives suggest a narrower FTO landscape but with potential overlaps in related chemical structures.

Competitive Positioning

  • The patent secures exclusivity over a distinct chemical entity with demonstrated therapeutic utility.
  • The specificity in claims limits infringement risks but invites challenges from prior art by very close analogs.
  • Expanded family filings increase patent lifetime and territorial coverage, strengthening market position.

Summary of Patent Strengths and Weaknesses

Aspect Strengths Weaknesses
Claim Breadth Covers chemical structure, use, and manufacturing Not overly broad, reducing risk of invalidation
Claim Specificity Focus on specific substituents, making infringement easier to detect Narrow structure limits scope to certain derivatives
Patent Family Strategy Multiple jurisdictions, extending territorial rights Larger costs and complexity in global patent management

Key Takeaways

  • U.S. Patent 10,548,880 protects a specific chemical compound and its therapeutic applications, with claims carefully crafted around particular structural features.
  • Its patent landscape includes related filings targeting similar chemical entities for diverse therapeutic indications.
  • The patent is effective at blocking certain close analogs but faces potential challenges from prior art in the same chemical class.
  • A thorough freedom-to-operate analysis is advisable before developing or commercializing derivatives or formulations.
  • The patent’s territorial scope is broad but relies on strategic family filings to ensure global coverage.

FAQs

Q1: What is the core innovation of U.S. Patent 10,548,880?
It is the specific chemical structure with modifications that enhance activity for treating certain diseases.

Q2: How broad are the claims of this patent?
Claims cover the compound, its methods of use, and manufacturing processes but are limited to particular structural features and therapeutic applications.

Q3: What constitutes potential patent infringement?
Producing or using compounds with the specified structure that fall within the claims, especially for the therapeutic indications specified.

Q4: How does prior art impact the patent’s validity?
Existing patents on related chemical classes could challenge novelty; the patent’s specific structural modifications aim to demonstrate non-obviousness.

Q5: What should companies consider before developing products related to this patent?
Conduct a comprehensive patent search and FTO analysis focusing on the specific chemical structure, proposed use, and geographical jurisdictions.


References

  1. United States Patent and Trademark Office. (2021). Patent No. 10,548,880.
  2. Espacenet. (2023). Patent family and prior art analysis.
  3. WIPO PATENTSCOPE. (2023). Patent landscape reports.
  4. USPTO Patent Application Publications. (2020–2023).
  5. PatentScope. (2023). International patent filings related to chemical compounds for therapeutic use.

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Drugs Protected by US Patent 10,548,880

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,548,880

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark2003 01232Aug 29, 2003
Denmark2003 01837Dec 11, 2003
Denmark2004 00079Jan 21, 2004

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