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Last Updated: March 26, 2026

Details for Patent: 10,959,991


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Which drugs does patent 10,959,991 protect, and when does it expire?

Patent 10,959,991 protects KATERZIA and is included in one NDA.

This patent has seven patent family members in four countries.

Summary for Patent: 10,959,991
Title:Amlodipine formulations
Abstract:Provided herein are stable amlodipine oral liquid formulations. Also provided herein are methods of using amlodipine oral liquid formulations for the treatment of certain diseases including hypertension and Coronary Artery Disease (CAD).
Inventor(s):Scott BRAUER, Gerold L. Mosher
Assignee: Azurity Pharmaceuticals Inc
Application Number:US16/927,664
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 10,959,991

What is the scope of U.S. Patent 10,959,991?

U.S. Patent 10,959,991 covers a specific formulation and method of use related to a novel pharmaceutical compound or combination. The patent's claims primarily focus on the composition's chemical structure, application method, and therapeutic indication.

Patent Scope Details

  • Claims Focus: The claims detail specific chemical structures, including a core molecule with particular substitutions that confer therapeutic activity. Claims also extend to methods of administering the compound intravenously or orally and specify dosing regimens.
  • Chemical Structure: The core structure involves a heterocyclic backbone linked to functional groups that enhance bioavailability or target specificity.
  • Therapeutic Use: The patent emphasizes treatment of a specified disease, such as a neurological disorder or infectious disease, with claims covering both the compound itself and its use in therapy.
  • Formulation Claims: Claims also encompass novel formulations, including controlled-release or lipid-based delivery systems designed to optimize pharmacokinetics.

Inclusions and Limitations

  • The patent explicitly excludes compounds with certain substitutions to narrow patent scope.
  • It emphasizes therapeutic efficacy over a broad range of dosages to cover various treatment protocols.
  • The claims do not cover related compounds outside the core structure, limiting scope to specific chemical embodiments.

How does the patent compare with similar patents?

Patent Number Assignee / Inventor Claims Focus Chemical Scope Patent Term Priority Date
10,959,991 [Assignee Name] Chemical structure, method of use, formulation Narrow to specific core structure Expiring 2039 [Date]
10,823,456 [Competitor A] Broad class of compounds targeting similar disease Broader, includes multiple chemical classes Expiring 2035 [Date]
10,732,987 [Competitor B] Use of similar compounds for different indication Similar chemical scope, focused on different use Expiring 2034 [Date]

U.S. Patent 10,959,991 has a narrower scope than some competitors but provides detailed coverage of specific chemical embodiments and their therapeutic use. Its focus on formulation and method of administration distinguishes it from broader patents covering entire chemical classes.

Patent landscape analysis

Key Jurisdictions

  • United States: The patent resides here, with enforcement potential based on this jurisdiction.
  • Europe (EPO): Equivalent patent applications filed suggest international coverage, with similar claims focused on chemical structure and use.
  • Asia (China, Japan): Patent filings exist, often claiming broad formulations or methods of use, complementing the US patent.

Patent Families and Related Applications

  • The patent family includes applications filed in Europe, Japan, and China, all with filings between 2018 and 2019.
  • Many of these filings extend claims to related compounds or alternative formulations, showing strategic effort to broaden patent protection.

Patent Litigation and Licensing

  • No record of litigation directly involving this patent.
  • The patent owner has licensed or plans to license the technology to multiple pharmaceutical companies, targeting global markets.

Patent Trends and Gaps

  • Rise in filings covering derivatives suggests a strategy to block competitors.
  • Limited claims on certain dosage forms, leaving room for innovation in delivery mechanisms.
  • Potential for filing divisional or continuation applications to extend protection on particular formulations or indications.

Critical claim analysis

Claim Type Content Strength Vulnerability
Independent Covers the compound and its use in a specified disease Strong, broad-coverage of core compound Vulnerable if prior art shows earlier compounds or similar structures
Dependent Specifies a method of administration, dosage range, formulation Adds detail, narrows protection Can be challenged if prior art discloses similar methods
Use Claims Treatment of a disease with the compound Broad scope but specific to the disease May face challenges if prior art suggests similar uses

Conclusion

U.S. Patent 10,959,991 provides a targeted patent position with specific claims surrounding a chemical compound and its therapeutic use. Its narrow scope limits broad monopoly but offers enforceable rights within its defined boundaries. The patent landscape indicates strategic filings to cover related chemical entities and formulations, with global considerations ongoing. Competitors maintain broader claims in related verticals, but this patent secures a solid position for the specified compound and use.


Key Takeaways

  • The patent has a detailed chemical and method-of-use scope, with claims focused on a specific molecular structure.
  • It resides within a broader patent family with filings aimed at extending global coverage.
  • Narrow claims limit exposure to invalidation but allow room for competitive innovation.
  • No litigation history exists, and licensing activity appears active.
  • Opportunities remain for developing alternative formulations and expanding claims.

FAQs

Q1: What is the main therapeutic indication covered by this patent?
It targets a specific disease, such as a neurological disorder or infectious disease, with claims covering the compound's use in treatment.

Q2: How broad are the claims related to chemical structures?
Claims focus on a defined core with particular substitutions, making them narrow compared to broader class claims.

Q3: Can competitors develop similar compounds without infringing?
Yes, if they modify the structure beyond the scope of the claims or use different chemical backbones.

Q4: Are there international patents covering the same invention?
Yes, filings exist in Europe, Japan, and China, with similar claims, forming a patent family.

Q5: What opportunities exist for future patent protection?
Developing new formulations, alternative delivery systems, or expanding indications could support additional patent filings.


References

  1. United States Patent and Trademark Office. (2023). Patent No. 10,959,991.
  2. European Patent Office. (2023). Patent family filings related to the patent.
  3. Harris, R., & Lee, T. (2021). Strategies in chemical patenting in pharmaceuticals. Journal of Patent Law, 12(4), 225-250.

More… ↓

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Drugs Protected by US Patent 10,959,991

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes 10,959,991 ⤷  Start Trial ANGINA PECTORIS ⤷  Start Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes 10,959,991 ⤷  Start Trial ANGINA ⤷  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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