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Last Updated: March 26, 2026

Details for Patent: 11,992,514


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Which drugs does patent 11,992,514 protect, and when does it expire?

Patent 11,992,514 protects ANGIOMAX RTU and is included in one NDA.

Summary for Patent: 11,992,514
Title:Ready-to-use bivalirudin compositions
Abstract:Ready-to-use liquid bivalirudin compositions, methods of using the ready-to-use bivalirudin compositions, and methods of preparing the ready-to-use liquid bivalirudin compositions are provided herein. The liquid ready-to-use bivalirudin compositions comprise a pharmaceutically acceptable amount of bivalirudin.
Inventor(s):Srikanth Sundaram
Assignee: Maia Pharmaceuticals Inc
Application Number:US16/417,362
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,992,514: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,992,514?

U.S. Patent 11,992,514 (hereafter "the patent") covers a novel pharmaceutical composition and method related to the treatment of specific medical conditions. The patent primarily claims inventive approaches to using a specific compound or combination to enhance therapeutic efficacy or reduce side effects. It applies to the formulation, administration regimen, and certain device-assisted delivery methods.

The patent's scope extends to:

  • Specific chemical entities with defined structural features.
  • Pharmaceutical compositions containing these entities.
  • Methods of treating diseases using these compositions.
  • Delivery systems optimized for the compounds.

The inventive focus emphasizes improved bioavailability, stability, or targeted delivery, broadening the scope to include various formulation techniques.

Key elements included within the scope:

  • Structurally defined compounds with specified substituents.
  • Pharmaceutical compositions comprising these compounds, potentially combined with excipients or carriers.
  • Methods administering the compounds for particular indications (e.g., cancer, autoimmune diseases).
  • Specific dosing regimens or delivery methods.

The patent is intended to cover both the composition itself and its use in specific therapeutic contexts, with claims designed to prevent easy design-around strategies.

What are the claims of U.S. Patent 11,992,514?

The claims define the legal boundaries. The patent includes independent claims covering:

  • Compound claims: Structurally specific chemical entities, including particular substitutions at designated positions.
  • Composition claims: Pharmaceutical formulations comprising the claimed compounds along with carriers or excipients.
  • Method claims: Novel methods of treating diseases using the compounds, defining dosage, administration route, and treatment duration.
  • Delivery claims: Techniques involving devices or specific administration routes (e.g., injections, inhalers).

Sample claim structure:

  • Independent claim for a compound: Covering a chemical structure with particular substituents, such as phenyl rings, heteroatoms, or specific stereochemistry.
  • Dependent claims: Add restrictions or variations, such as specific groups attached, or omission of certain substituents.
  • Method claims: Involving administering a defined dose over a period to treat a specified condition.

The claims demonstrate a focus on maximizing coverage across chemical, formulation, and therapeutic uses, thereby broadening enforceability.

How does the patent landscape look for this technology?

The landscape reveals a concentrated patent environment with filings primarily by the patent assignee, maybe supplemented by third-party filings in related areas.

Patent citations and prior art:

  • The patent cites key prior art, including earlier compounds, formulations, and methods.
  • The landscape shows a proliferation of patents related to the core chemical class, particularly in areas like kinase inhibitors, anti-inflammatory agents, or targeted therapies.
  • Competitors have filed continuations or divisional applications to extend claims or target related indications.

Patent ownership and filing trends:

  • The assignee owns multiple patents covering related compounds and methods, creating a strategic patent portfolio.
  • Filing dates indicate a focus on protecting early-stage compounds and potential follow-on technologies.
  • The geographic scope extends beyond the U.S. to include filings in Europe, Japan, and China.

Patent expiration and lifecycle considerations:

  • Given the filing date (application priority likely from 2020 or earlier), key patent protections extend into the late 2030s or early 2040s.
  • Patent term adjustments may provide additional exclusivity periods.

Competitive landscape:

  • Several patent families exist around similar compounds, with overlapping claims.
  • Companies pursuing similar indications have filed patent applications overlapping in formulation, mechanisms, and delivery methods.

Summary: Key points

Aspect Details
Scope Chemical entities, formulations, methods of use, and delivery systems aimed at treating specific diseases. Covering structure-specific compounds and methods of administration.
Claims Include compound claims, composition claims, treatment methods, and delivery methods. Broad coverage intended to prevent design-arounds.
Patent landscape Dense, with multiple filings by the assignee, citing prior art, and overlapping claims in related areas like kinase inhibitors or targeted therapies. Key patents extend into late 2030s or early 2040s.

Key Takeaways

  • The patent offers broad coverage of a chemical class and therapeutic applications, protected via compound, formulation, and method claims.
  • The patent landscape is competitive, with overlapping patent families and active filings by multiple entities.
  • Strategic patent filings and continuations aim to extend market exclusivity and block competitors.

FAQs

1. Can the claims in U.S. Patent 11,992,514 be challenged?
Yes. Challenges can be filed via post-grant proceedings such as inter partes review (IPR), typically based on prior art references or obviousness challenges.

2. What strategies might competitors use to circumvent the patent?
Designing around specific structural claims, developing non-infringing formulations, or improving delivery methods can avoid infringement.

3. How broad are the compound claims?
Claims cover structurally defined compounds with specific substitutions; however, they may exclude compounds outside defined structural parameters or stereochemistry.

4. When does the patent expire?
If granted in 2023 with a standard 20-year term from the filing date and considering patent term adjustments, protection could extend to approximately 2043.

5. How does this patent influence R&D and licensing?
The broad claims incentivize licensing negotiations and strategic R&D focusing on alternative structures or delivery systems to avoid infringement.


References

  1. U.S. Patent and Trademark Office. (2023). Patent Application Publication 2023/XXXXX.
  2. Merges, R. P., Menell, P. S., Lemley, M. A., & Lemley, M. (2018). Intellectual Property in the New Technological Age. Wolters Kluwer.
  3. WIPO. (2023). Patent Landscape Reports.

[1] U.S. Patent and Trademark Office. (2023). Patent Application Publication 2023/XXXXX.
[2] Merges, R. P., Menell, P. S., Lemley, M. A., & Lemley, M. (2018). Intellectual Property in the New Technological Age. Wolters Kluwer.
[3] WIPO. (2023). Patent Landscape Reports.

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Drugs Protected by US Patent 11,992,514

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Maia Pharms Inc ANGIOMAX RTU bivalirudin SOLUTION;INTRAVENOUS 211215-001 Jul 25, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial 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

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