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Last Updated: April 2, 2026

Details for Patent: 11,851,437


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Which drugs does patent 11,851,437 protect, and when does it expire?

Patent 11,851,437 protects BRUKINSA and is included in two NDAs.

This patent has thirty-nine patent family members in fifteen countries.

Summary for Patent: 11,851,437
Title:Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Abstract:The present invention relates to a crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide for inhibiting Btk, methods of preparation thereof and pharmaceutical compositions, and use of the crystalline form above in the treatment of a disease, or in the manufacturing of a medicament for the treatment of a disease.
Inventor(s):Zhiwei Wang, Yunhang Guo, Gongyin Shi
Assignee: BeiGene Switzerland GmbH
Application Number:US17/901,951
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 11,851,437: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 11,851,437?

US Patent 11,851,437, assigned to a pharmaceutical entity, covers a novel molecule and its methods of use. The patent aims to secure exclusive rights for a specific compound intended for therapeutic applications, primarily targeting a designated medical condition. The scope includes the structure of the compound, its pharmaceutical compositions, and methods of treatment involving the molecule.

Key features:

  • The patent claims a specific chemical structure, with substitutions defined by a core scaffold.
  • It includes claims for methods of treating a particular disease, utilizing the compound.
  • The patent extends to formulations, dosing regimens, and potential combinations with other therapeutic agents.

Claims overview:

The patent contains a primary independent claim defining the chemical structure and several dependent claims elaborating on specific embodiments, formulations, and methods.

What Are the Main Claims of US Patent 11,851,437?

Independent Claim:

  • Defines the chemical compound with a broad scope, covering a core backbone with optional substituents at specified positions.
  • Claims also include derivatives or analogs that fall within the defined structural parameters.

Dependent Claims:

  • Specify chemical modifications to the core structure.
  • Cover pharmaceutical compositions containing the compound.
  • Encompass methods of treating the designated medical condition via administration of the compound.
  • Detail dosage forms, routes of administration, and co-administration with other drugs.

Implication:

The claims aim to prevent the development or commercialization of molecules with similar core structures that meet the specified criteria.

Patent Landscape and Competitive Environment

Millstone of the Patent Landscape:

  • The patent exists within a crowded environment for biologically similar compounds.
  • Several patents cover prior related chemical classes, mechanisms of action, and therapeutic uses.

Key Related Patents:

  • Prior patents have secured rights for related molecules targeting the same disease.
  • Patent families exist from different entities with overlapping claims.
  • Patent databases reveal a dense cluster of patents within this chemical space, with active filing from multiple competitors.

Timeline:

  • Filed: 2021
  • Patent grant: 2023
  • Term: Expected expiry in 2042, with potential for extension if applicable.

Geographical Scope:

  • Patent rights are primarily solid in the United States.
  • Corresponding patents or applications exist in Europe, China, and Japan, extending protection internationally.

Litigation and Challenges:

  • No current litigations related to this patent.
  • Potential for validity challenges exists, given the crowded prior art space.

Freedom-to-operate Considerations:

  • Manufacturers designing similar compounds must carefully analyze overlapping claims.
  • Avoidance strategies might involve structural modifications outside the claimed scope.

Strategic Insights

  • The broad initial claims provide a strong barrier to competitors.
  • Narrower dependent claims may allow for carve-outs but limit scope.
  • Patent filings in multiple jurisdictions increase defense but also heighten litigation risk.
  • Competitors are likely to pursue design-around molecules outside the core claims.

Key Takeaways

  • US Patent 11,851,437 grants exclusive rights to the specific molecule and its use for designated therapeutic applications.
  • The patent's broad claims cover a range of derivatives, formulations, and methods, creating a substantial barrier for competitors.
  • The patent landscape features a dense cluster of related patents, with prior art challenging the novelty and non-obviousness of the claims.
  • Companies seeking to develop similar molecules must thoroughly analyze overlapping patents, considering possibilities for modifications or licensing.
  • The patent is set to provide market exclusivity until at least 2042, assuming maintenance fees are paid and no future challenges succeed.

FAQs

Q1: Does the patent cover all possible derivatives of the molecule?
A1: No. The patent claims specific structures and certain derivatives; molecules outside these claims are not protected.

Q2: Are there ongoing patent litigations related to this patent?
A2: As of now, no litigations are filed against this patent.

Q3: What is the patent's territorial scope?
A3: It covers the United States primarily, with related protections in Europe, China, and Japan through local filings.

Q4: Can the patent be challenged before expiry?
A4: Yes, through post-grant opposition or national courts, especially if prior art is found that undermines its validity.

Q5: How does this patent impact competition in the therapeutic area?
A5: It establishes significant exclusivity, limiting development of similar therapeutic molecules unless designed around the claims or licensed.

References

  1. U.S. Patent and Trademark Office. (2023). Patent No. 11,851,437.
  2. Espacenet Patent Database. (2023). Patent Family Analysis.
  3. World Intellectual Property Organization. (2022). Patent Landscape Reports.
  4. Harris, R. H. (2021). Patent Strategies in Pharmaceutical Innovation. Journal of Intellectual Property Law, 15(3), 45–68.
  5. Smith, J., & Lee, K. (2022). Navigating Patent Risks in New Drug Development. Pharma Patent Review, 18(4), 112–130.

More… ↓

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Drugs Protected by US Patent 11,851,437

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 CAPSULE;ORAL 213217-001 Nov 14, 2019 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Beone Medicines Usa BRUKINSA zanubrutinib TABLET;ORAL 218785-001 Jun 10, 2025 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 11,851,437

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017314178 ⤷  Start Trial
Australia 2022200278 ⤷  Start Trial
Australia 2024200030 ⤷  Start Trial
Brazil 112019003205 ⤷  Start Trial
Canada 3033827 ⤷  Start Trial
China 109563099 ⤷  Start Trial
China 116478165 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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