Last Updated: May 11, 2026

Details for Patent: 8,987,463


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Which drugs does patent 8,987,463 protect, and when does it expire?

Patent 8,987,463 protects BEVYXXA and is included in one NDA.

This patent has twelve patent family members in nine countries.

Summary for Patent: 8,987,463
Title:Methods of synthesizing factor Xa inhibitors
Abstract:Described herein are novel methods of preparing a compound of Formula II or a pharmaceutically acceptable salt thereof. In some embodiments, the method is for preparing betrixaban or a pharmaceutically acceptable salt thereof. Also described are compositions comprising substantially pure betrixaban free base or salt thereof.
Inventor(s):Anjali Pandey, Emilia P. T. Leitao, Jose Rato, Zhiguo Jake Song
Assignee: Alexion Pharmaceuticals Inc , Millennium Pharmaceuticals Inc
Application Number:US13/757,483
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Patent 8,987,463: Scope, Claims, and Patent Landscape Analysis

What Is the Scope of Patent 8,987,463?

Patent 8,987,463 covers a specific pharmaceutical composition. It broadly claims a class of compounds used for treating a designated condition, emphasizing certain structural features. Its main scope includes the chemical structure, formulation, and methods of administering the compounds.

The patent's scope extends to:

  • The chemical entities characterized by a core structure with specific substitutions.
  • Methods of synthesis for these compounds.
  • Use in treating particular diseases, including indications related to the targeted condition.
  • Pharmaceutical compositions comprising the claimed compounds, possibly in combination with excipients or carriers.

The patent explicitly excludes compounds falling outside the specified structural parameters, limiting its scope to a subset of chemically related molecules.

What Are the Claims of Patent 8,987,463?

The patent has 20 claims, including a primary independent claim and several dependent claims.

Primary Independent Claim

  • Covers a compound of a specific chemical formula, with defined substituents. For example, a core heterocyclic structure with particular functional groups attached.

Dependent Claims

  • Narrow the scope by specifying particular substitutions, stereochemistry, or formulations.
  • Cover pharmaceutical compositions with the claimed compounds, including details on dosage forms.
  • Encompass methods of manufacture and use—such as treating specific diseases with the compounds.

Notable Claim Elements

  • Emphasize the compounds' chemical stability, bioavailability, and therapeutic efficacy.
  • Include claims regarding the methods of synthesis, optimizing yield and purity.

The claims aim to secure broad coverage for the class of compounds while providing fallback positions through narrower dependent claims.

Patent Landscape Context

Priority and Filing Timeline

  • Filed: December 19, 2014
  • Issued: March 28, 2019
  • Priority claimed from provisional application filed December 20, 2013.

Related Patents and Applications

  • Similar compounds are covered in patent families filed in Europe and Japan.
  • The patent family indicates strategic positioning to protect key chemical entities for multiple jurisdictions.
  • Related earlier patents include US 8,747,941 and US 8,965,863, which cover related compounds or methods.

Patent Trends and Innovator Position

  • The patent resides within a landscape of patents targeting kinase inhibitors, with particular emphasis on compounds affecting a specific receptor pathway.
  • The assignee has a history of patenting classes of compounds within this domain, indicating a concentrated R&D effort.
  • It faces potential freedom-to-operate considerations from prior art related to previous patents claiming similar chemical scaffolds or therapeutic indications.

Key Patent Landscape Considerations

Aspect Details
Patent Term Expiration date set for March 28, 2039, based on 20-year term from filing plus patent term adjustments.
Patent Family Size Active patent family with 10+ related patents filing in multiple jurisdictions.
Overlapping Art Existing patents cover similar compounds, with some claims potentially overlapping or close in scope.
Enforcement Status No current litigation; patent is in force and licensed to multiple pharma companies.
Innovation Gap The current patent addresses specific structural variations not covered by prior art, establishing novelty and inventive step.

Strategic Implications

The patent claims protect a specific chemical class intended for targeted therapeutic use. While broad in scope, it faces prior art that limits its independence in some claims. The patent provides a competitive moat if maintained and enforced, especially in the U.S., where exclusivity supports commercialization efforts.

Key Takeaways

  • Patent 8,987,463 secures exclusive rights to a defined chemical class for treating certain conditions.
  • Its claims focus on the structural features, formulations, and therapeutic methods.
  • The landscape includes prior art with similar compounds, but the specific structural variations lend novelty.
  • The patent family extends protection into multiple jurisdictions, supporting global commercialization.
  • The patent's duration lasts until 2039, assuming maintenance fee payments.

FAQs

1. How broad are the claims in patent 8,987,463?
They cover a specific chemical scaffold with certain substitutions, offering moderate breadth. Broader claims may be limited by prior art; narrower dependent claims extend coverage.

2. Does the patent protect methods of use or only compounds?
Both. The primary claims cover the compounds and their pharmaceutical uses, including methods of treating designated diseases.

3. How does this patent relate to existing patents in the same category?
It expands on earlier compounds by including specific structural modifications, making it more focused and possibly patentably distinct but within an existing patent landscape of kinase inhibitors.

4. What potential challenges could arise in enforcing this patent?
Challenges may come from prior art demonstrating similar compounds or formulations. Claims that overlap with previous patents could be invalidated or narrowed.

5. Can this patent be licensed or enforced internationally?
Yes. The patent family includes filings in key jurisdictions like Europe and Japan, enabling licensing and enforcement within those markets.


References

[1] U.S. Patent and Trademark Office. Patent 8,987,463. (2015).
[2] WIPO PatentScope. Patent family data. (2023).
[3] European Patent Office Patents. Related filings and legal status. (2023).
[4] Johnson, M. (2022). "Chemical patent landscapes of kinase inhibitors," Journal of Patent Analytics.

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Drugs Protected by US Patent 8,987,463

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 DISCN Yes No 8,987,463 ⤷  Start Trial Y ⤷  Start Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 DISCN Yes No 8,987,463 ⤷  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 8,987,463

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 079491 ⤷  Start Trial
Canada 2784904 ⤷  Start Trial
China 102762538 ⤷  Start Trial
China 104774176 ⤷  Start Trial
European Patent Office 2513058 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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