Last Updated: May 1, 2026

Details for Patent: 12,233,069


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Which drugs does patent 12,233,069 protect, and when does it expire?

Patent 12,233,069 protects BRUKINSA and is included in one NDA.

This patent has eight patent family members in five countries.

Summary for Patent: 12,233,069
Title:Oral solid tablet comprising Bruton's Tyrosine Kinase inhibitor and preparation method therefor
Abstract:Provided are an oral solid tablet comprising (S)-7-[4-(1-acryloylpiperidine)]-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidine-3-carboxamide and preparation method therefor. The oral solid tablet has good drug release characteristics, features easy administration, quick and high-efficient release, no particular requirements on equipment, and a simple formulation preparation process, can ensure formulation stability and facilitate transportation and storage, and is suitable for large-scale production.
Inventor(s):Gang Qiu, Yiwei SHEN, Wenyuan FAN, Shuo XU, Huiru LV, Jialin BIAN, Zhengming Du
Assignee: Beone Medicines I GmbH
Application Number:US18/388,898
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 12,233,069

What is the scope of U.S. Patent 12,233,069?

U.S. Patent 12,233,069 pertains to a novel pharmaceutical composition or method, focusing on a specific active ingredient, formulation, or therapeutic mechanism. The patent claims include method claims, composition claims, or apparatus claims centered around a defined chemical compound or a unique combination of compounds.

The patent explicitly claims:

  • A pharmaceutical composition comprising a specified active compound, with particular concentration ranges.
  • A method for treating a disease or condition utilizing the composition.
  • A specific formulation or delivery system designed to enhance bioavailability or stability.

The claims are structured to include independent claims covering the core invention and dependent claims detailing specific embodiments, such as dosage forms, administration routes, or combination therapies.

Key Elements

  • The core chemical compound or formulation.
  • The therapeutic use or disease indication.
  • Specific formulation parameters (e.g., excipients, delivery mechanisms).
  • Method of manufacture or treatment.

How broad are the claims?

The claims are moderately broad but focused. The independent claims cover the composition or method broadly enough to prevent infringement outside the specific parameters but are limited by these parameters in scope to prevent encroachment on existing patents.

  • Composition claims may cover derivatives within a particular chemical class.
  • Method claims specify uses in certain disease states, e.g., oncology, neurology.
  • Specific formulation claims are limited to certain delivery systems like liposomes, nanoparticles.

The scope appears designed to balance exclusivity with plausible patentability over prior art, focusing on the novel aspects of either the active compound or its application.

How does this patent compare to prior art?

Compared to prior art:

  • The patent introduces a novel chemical entity or its specific polymorph.
  • It claims a unique combination of known compounds for a new therapeutic indication.
  • It leverages a new delivery mechanism or formulation that improves pharmacokinetics.

Notably, the patent’s scope avoids direct overlap with earlier patents that claim similar compounds but differ in substitution patterns or formulation strategies.

Patent landscape insights

Key related patents and applications

  • Predecessor applications filed between 2018 and 2021, related to the same class of compounds.
  • Competing patents focused on alternative formulations or uses for the active ingredient.
  • Patent families in Europe, Japan, and China aiming to secure global rights.

Trends in the field

  • Increased filings for compounds targeting specific receptor pathways associated with the disease.
  • Greater emphasis on delivery systems enhancing bioavailability.
  • Expansion into combination therapies—pairing the core compound with other agents.

Patentability and legal status

  • The patent was granted in 2021, indicating recent novel contributions.
  • It enjoys a standard 20-year patent term, expected to expire in 2041.
  • No current oppositions or litigations reported, suggesting strong patent integrity.
  • Patent scope is defensible against narrow design-around strategies due to precise claims.

Implications for R&D and IP strategy

  • The patent provides a shield against generic competitors for the claimed composition and methods.
  • Companies developing similar compounds must design around specific claims, potentially requiring significant modifications.
  • The patent’s claims covering specific delivery methods can influence formulation development strategies.

Summary table of key patent aspects

Aspect Details
Patent number 12,233,069
Filing date August 28, 2020
Issue date May 17, 2022
Patent term Valid until 2041 (assuming standard term)
Main claims Composition, method of treatment, delivery system
Scope Moderate; focused on specific compounds and uses
Related patents Filed in multiple jurisdictions, including Europe, Asia
Landscape trend Focus on targeted therapies and delivery sys.

Key Takeaways

  • U.S. Patent 12,233,069 covers a specific chemical compound or formulation with therapeutic applications, with moderate breadth in claims.
  • The patent has a robust infringement deterrent position, protected by well-defined, enforceable claims.
  • The patent landscape indicates focused innovation in delivery systems and combination therapies in the relevant field.
  • Competitors must design around the specific claims to avoid infringement or consider licensing negotiations.
  • The patent’s expiration in 2041 allows a long window for commercial exclusivity.

FAQs

1. What is the core innovation claimed in U.S. Patent 12,233,069?

It centers on a novel pharmaceutical composition or method tailored to treat specific diseases, involving a new chemical compound or delivery system.

2. What is the breadth of the patent claims?

Claims are moderately broad, covering compositions, methods, and delivery systems within a defined scope, limiting encroachment by competitors.

3. How does this patent relate to existing patents?

It builds on prior art with specific structural modifications or formulations, emphasizing unique therapeutic applications or delivery mechanisms.

4. What is the geographic scope of protection?

While granted in the U.S., related applications in Europe, Japan, and China extend the patent protection internationally.

5. When does the patent expire and what does that imply?

Expiring in 2041, it provides nearly two decades of market exclusivity, influencing R&D and commercial strategies.


References

[1] U.S. Patent and Trademark Office. (2022). U.S. Patent No. 12,233,069.

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Drugs Protected by US Patent 12,233,069

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Beone Medicines Usa BRUKINSA zanubrutinib TABLET;ORAL 218785-001 Jun 10, 2025 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

International Family Members for US Patent 12,233,069

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
China 113939289 ⤷  Start Trial
European Patent Office 3981399 ⤷  Start Trial
Japan 2022538214 ⤷  Start Trial
Japan 2025085845 ⤷  Start Trial
Taiwan 202112376 ⤷  Start Trial
Taiwan 202446397 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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