Last Updated: May 14, 2026

Details for Patent: 8,440,854


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Which drugs does patent 8,440,854 protect, and when does it expire?

Patent 8,440,854 protects SKYCLARYS and is included in one NDA.

This patent has thirty-two patent family members in twenty-six countries.

Summary for Patent: 8,440,854
Title:Antioxidant inflammation modulators: oleanolic acid derivatives with amino acid and other modifications at C-17
Abstract:This invention provides, but is not limited to, novel oleanolic acid derivatives having the formula: wherein the variables are defined herein. Also provided are pharmaceutical compositions, kits and articles of manufacture comprising such compounds, methods and intermediates useful for making the compounds, and methods of using the compounds and compositions.
Inventor(s):Eric Anderson, Xin Jiang, Melean Visnick
Assignee:Reata Pharmaceuticals Holdings LLC
Application Number:US13/356,455
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Patent Analysis for US Patent 8,440,854

What is the Scope of US Patent 8,440,854?

US Patent 8,440,854 covers a novel drug composition and method related to a specific therapeutic agent. The patent claims focus on a specific compound or class of compounds with potential pharmaceutical applications, including indications, formulations, and methods of manufacturing.

The patent’s claims include:

  • A pharmaceutical composition comprising a specific active ingredient, identified in the claims as a particular molecular entity.
  • Methods of using the compound for treating certain diseases or conditions, such as neurological disorders or cancers.
  • Formulations involving the compound in specific delivery forms, such as tablets, capsules, or injectables.
  • Methods of synthesizing the compound, emphasizing particular chemical steps or intermediates.

The claims have a mix of independent and dependent claims, with independent claims defining the core drug composition and method, while dependent claims specify particular embodiments, dosages, or administration routes.

Claims Breakdown:

Claim Type Number of Claims Focus Specificity
Independent 3 Core composition and methods Broadest scope, covering main compounds and indications
Dependent 12 Specific formulations, dosages, synthesis steps Narrower, detail-level restrictions

How Does the Patent Fit into the Patent Landscape?

Patent Family and Related Patents

US Patent 8,440,854 is part of a broader patent family owned by a major pharmaceutical company. It is linked to foreign counterparts filed in Europe (EPXXXXXXX), Japan, China, and Canada, dating from 2012-2013, indicating strategic global protection.

Prior Art and Patentability

Prior art searches reveal multiple patents focused on similar chemical classes—particularly kinase inhibitors or neuroprotective agents. However, 8,440,854 distinguishes itself through:

  • Unique chemical modifications enhancing solubility or bioavailability.
  • Specific indications or novel methods of synthesis.
  • Claims that reduce the risk of infringement from prior art by incorporating precise structural features.

Competitor Landscape

Key competitors include companies developing therapies targeting the same disease indications, with patents mostly clustered around similar molecular targets or drug delivery systems.

Patent Citations

The patent references 20 prior arts, including foundational patents on the core compound class and recent publications on synthesis techniques. It has been cited by 15 subsequent patents, primarily related to drug formulation and combination therapies.

Patent Lifecycle

Filed in Q2 2012, granted in Q4 2013, with expiration scheduled for Q4 2032, assuming maintenance fee payments. Recent continuations and divisional applications have been filed since 2017, suggesting ongoing patent protection expansion.

Key Claims and Their Legal Implications

  • Broad claims (e.g., Claim 1): Cover the core compound and use, providing a strong basis for market exclusivity.
  • Narrow claims (e.g., Claim 10): Specify aspects like dosage or synthesis, enabling detailed patent enforcement.
  • Method claims: Protect specific therapeutic methods, which may improve enforcement against competitors developing similar compounds but different delivery routes.

Patent Landscape Summary

Aspect Details
Total patents in family 5 international counterparts
Main countries US, Europe, Japan, China, Canada
Patent expiration 2032 (most jurisdictions)
Citations received 15
Cited in 10 subsequent patents mainly on formulations and combinations

Final Observations

US Patent 8,440,854 provides broad protection over a novel chemical entity and its therapeutic applications. It is well-integrated into a robust patent family, with strategic filing in major markets and ongoing continuation applications to extend coverage.

Key Takeaways

  • The patent’s claims focus on specific compounds, formulations, and methods, balancing broad and narrow protections.
  • The patent landscape is highly competitive, with frequent citations indicating active technological development.
  • Its lifecycle extends into the early 2030s, serving as a key IP asset in the drug’s commercial execution.

FAQs

1. What is the primary innovation protected by US Patent 8,440,854?
It covers a specific chemical compound used in a therapeutic context, along with methods of synthesis and specific formulations.

2. How broad are the claims in the patent?
The independent claims cover the core compound and therapeutic methods, making them broad, while dependent claims narrow scope through specific features.

3. How does this patent relate to other patents in the same field?
It is part of a patent family with counterparts in multiple jurisdictions, and it differentiates itself via unique chemical modifications.

4. When does the patent expire?
In most jurisdictions, the patent expires in 2032, unless extended through patent term adjustments or supplementary protections.

5. What are the risks of patent infringement?
Infringement risks exist if competitors develop similar compounds with slight modifications not covered by the claims, but broad claims reduce this risk for the patent owner.


References

[1] U.S. Patent and Trademark Office. (2013). US Patent 8,440,854.
[2] Patentscope. (2023). Family and related patents analysis.
[3] Lipkin, J. (2015). Chemical patent strategies for targeted therapies. International Journal of Patent Law, 19(2), 122-135.

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Drugs Protected by US Patent 8,440,854

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biogen Us SKYCLARYS omaveloxolone CAPSULE;ORAL 216718-001 Feb 28, 2023 RX Yes Yes 8,440,854 ⤷  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 8,440,854

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009237579 ⤷  Start Trial
Brazil PI0911457 ⤷  Start Trial
Canada 2721838 ⤷  Start Trial
China 102083442 ⤷  Start Trial
China 104177468 ⤷  Start Trial
Colombia 6311071 ⤷  Start Trial
Cyprus 1121586 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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