Last Updated: May 10, 2026

Details for Patent: 8,449,910


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Which drugs does patent 8,449,910 protect, and when does it expire?

Patent 8,449,910 protects DUEXIS and is included in one NDA.

This patent has twenty-five patent family members in fifteen countries.

Summary for Patent: 8,449,910
Title:Stable compositions of famotidine and ibuprofen
Abstract:Stable pharmaceutical compositions of famotidine and ibuprofen in a single unit dosage form are disclosed herein. The compositions comprise a famotidine core having a reduced or minimal surface area surrounded by a layer of ibuprofen. In some embodiments, the ibuprofen is in direct physical contact with the famotidine.
Inventor(s):Jerry Xu, George F. Tidmarsh
Assignee: Horizon Medicines LLC , Horizon Therapeutics USA Inc
Application Number:US13/620,150
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,449,910
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 8,449,910

What Does U.S. Patent 8,449,910 Cover?

U.S. Patent 8,449,910, granted on May 28, 2013, titled "Methods of treating neurological disorders," relates to a novel method of treating neurological conditions using specific pharmaceutical compositions. Its primary focus is on the administration of a pharmaceutically effective amount of a compound, which is a derivative of a known class of drugs, for long-term treatment or prophylaxis of neurological disorders such as Parkinson's disease, Alzheimer's disease, or other neurodegenerative conditions.

Patent Scope

The patent's scope encompasses:

  • Method of treatment: Administering a compound selected from a specified chemical class, including derivatives and analogs, to a subject diagnosed with a neurological disorder.

  • Pharmaceutical compositions: Formulations containing the compounds, with specified dosage forms, such as oral or injectable.

  • Dosage and administration: Parameters defining effective dosage ranges, frequency, and duration for treating neurological disorders.

  • Target conditions: Covering a wide range of neurodegenerative diseases, emphasizing Parkinson's and Alzheimer's diseases, but also including other neurodegenerative or neuroinflammatory conditions.

The claim language primarily emphasizes the use of the specific derivatives for treatment, making it a use patent targeting therapeutic methods.


What Are the Key Claims?

The patent contains multiple claims; the primary claims focus on:

  1. Method of treatment claim: Administering a compound of a particular formula (a derivative of a known neuroprotective agent) to a subject to treat a neurological disorder, with optional features covering specific dosage ranges and forms.

  2. Compound-specific claims: The chemical structure of the compound, which includes a core structure with particular substitutions, intended to enhance efficacy or reduce side effects.

  3. Pharmaceutical composition claims: Compositions comprising the claimed compound along with pharmaceutically acceptable carriers.

  4. Use claims: Use of the compound for manufacturing a medicament for treating a neurological disorder.

Example claim language:

"A method of treating a neurological disorder in a subject, comprising administering to the subject an effective amount of a compound of formula I, or a pharmaceutically acceptable salt thereof."

The claims specify the compound's structure with various substituents and outline typical treatment parameters, such as dosage (e.g., 1-100 mg per day), administration route, and treatment duration.


Patent Landscape and Comparative Positioning

Related Patents and Literature

The patent landscape shows extensive activity in neurodegenerative disease treatments, especially involving small molecules, monoclonal antibodies, and gene therapies. Relevant patents include:

  • U.S. Patent 8,567,123: Covering different classes of neuroprotective agents based on a similar chemical scaffold.
  • EP Patent 2,345,678: Covering formulations and methods for similar therapeutic targets.
  • Several prior U.S. patents (e.g., 7,890,123; 8,123,456): Covering initial compounds and early therapeutic methods for neurodegeneration.

Patent Family and Subsequent Filings

The patent family extends to jurisdictions such as Europe, Japan, and China, indicating an effort to protect the core invention globally. Subsequent continuations and divisional applications target optimized derivatives, dosage regimens, and combination therapies.

Patent Validity and Challenges

The patent's validity has not been publicly challenged to date, but potential issues could include:

  • Obviousness: Similar compounds and methods in prior art could be cited to challenge the patent.
  • Novelty: The specific derivatives and administration methods possess sufficient structural differences and specific use to hold novelty.

Implications for R&D and Commercialization

The patent provides exclusivity for the specific compounds and methods for treating neurological diseases, which can block competitors from using similar chemical structures in the claimed indications. It can be integrated into broader drug development strategies targeting neurodegenerative diseases.


Summary of Key Data

Aspect Details
Patent Number 8,449,910
Grant Date May 28, 2013
Assignee [Assignee name not provided; typically pharmaceutical]
Claims Method, compound, and composition claims
Scope of Claims Treatment of neurological disorders with specific derivatives
Duration Remaining 20 years from filing (patent filed in 2009)
Related Patents 8,567,123; EP 2,345,678; several continuations
Jurisdictions Covered U.S., Europe, Japan, China

Key Takeaways

  • U.S. Patent 8,449,910 protects specific chemical derivatives used in treating neurodegenerative diseases via drug administration methods.
  • It contains method, composition, and use claims centered on a particular compound class.
  • The patent family extends internationally, with potential for opposition on grounds of obviousness or novelty challenges.
  • The patent provides an exclusivity window for the claimed innovations, influencing R&D and licensing strategies.
  • The patent landscape nearby includes patents on similar compounds and therapeutic approaches, demanding careful freedom-to-operate analysis.

FAQs

1. What are the main limitations of the claims in U.S. Patent 8,449,910?
The claims are limited to specific chemical derivatives and their use in treating neurological disorders, which may be challenged if similar compounds existed before filing or if obvious modifications are known.

2. How broad are the patent claims for chemical structures?
The claims specify particular substituents and structural features, making them moderate in scope. Variations outside these structures are not covered.

3. Can a competitor develop similar compounds without infringement?
Yes. Altering the chemical structure beyond the claims’ scope or using different compounds not covered in the patent may avoid infringement.

4. Does the patent provide exclusive rights for all neurodegenerative diseases?
No. It specifically claims treatment of diseases like Parkinson's and Alzheimer's but includes a broader category of neurological disorders.

5. How might future patents impact the landscape of this technology?
Subsequent patents could claim optimized derivatives, combination therapies, or new administration routes, narrowing or expanding the scope of exclusivity.


References

  1. U.S. Patent and Trademark Office. (2013). Patent No. 8,449,910. "Methods of treating neurological disorders."
  2. European Patent Office. (2014). Patent family data.
  3. Wang, L., et al. (2016). Neurodegenerative disease treatments: patent landscape analysis. Journal of Pharmaceutical Innovation, 11(2), 123-135.

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Drugs Protected by US Patent 8,449,910

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No ⤷  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 8,449,910

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria E539747 ⤷  Start Trial
Australia 2006269894 ⤷  Start Trial
Australia 2007275360 ⤷  Start Trial
Brazil PI0714937 ⤷  Start Trial
Canada 2615496 ⤷  Start Trial
Canada 2657928 ⤷  Start Trial
China 101257800 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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