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Last Updated: March 26, 2026

Details for Patent: 8,778,924


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Which drugs does patent 8,778,924 protect, and when does it expire?

Patent 8,778,924 protects MOXATAG and is included in one NDA.

This patent has eleven patent family members in six countries.

Summary for Patent: 8,778,924
Title:Modified release amoxicillin products
Abstract:An amoxicillin product comprising: at least one modified release component(s), wherein the at least one modified release component(s) comprises at least amoxicillin and a pharmaceutically acceptable carrier; and wherein when administered to a patient or subject in the fed state said amoxicillin product exhibits a pharmacokinetic profile for amoxicillin in the plasma characterized as follows: (1) the ratio of the portion of the AUC as measured from 2 hours post-administration to 5 hours post-administration to the portion of the AUC as measured from administration to 2 hours post-administration is at least 2.0:1; and (2) the ratio of the portion of the AUC as measured from 5 hours post-administration to 12 hours post-administration to the portion of the AUC as measured from administration to 2 hours post-administration is at least 1.1:1.
Inventor(s):Henry H. Flanner, Sanna Tolle-Sander, Donald Treacy, Beth A. Burnside, Susan P. Clausen
Assignee:Shionogi Inc
Application Number:US11/633,315
Patent Claim Types:
see list of patent claims
Compound; Use;
Patent landscape, scope, and claims:

Summary
U.S. Patent 8,778,924 relates to a specific pharmaceutical composition or method involving a drug candidate. Its scope encompasses claims aimed at protecting particular formulations or therapeutic methods, which likely include several dependent claims for derivative forms or usages. The patent landscape shows active filings and related patents, indicating competitive dynamics and ongoing innovation in the same class or target. A comprehensive review reveals the breadth and limitations of its claims and positioning within the current patent environment.


What Is the Scope of U.S. Patent 8,778,924?

Main Claims Overview

U.S. Patent 8,778,924 contains a set of claims—primary and dependent—that define the scope of innovation. The primary claim generally covers a specific formulation, compound, or method involving the drug. Dependent claims narrow the scope by adding features such as:

  • Specific dosage forms or excipients
  • Particular methods of administration
  • Combinations with other therapeutic agents

Example: The main claim may involve a pharmaceutical composition comprising a certain active ingredient in a predefined range of concentrations in a specific delivery vehicle. Dependent claims could specify additional components or conditions, such as stabilizers or temperature ranges.

Claim Language and Limitations

The language used in claims relaxes or tightens scope:

  • Broad claims may cover any formulation of the active ingredient, regardless of carrier or delivery method.
  • Narrow claims specify exact molecular forms, concentrations, or methods.

Typically, the patent aims to protect a novel compound, formulation, or application, but its enforceability depends on how clearly these claims distinguish from prior art.

Patent Claims Breakdown

Type Content Limitations
Independent Claim Focuses on the core invention (e.g., a pharmaceutical composition with a specific compound and dosage). Defines the scope of the patent, often broad but susceptible to prior art challenges.
Dependent Claims Specify particular embodiments, such as specific administration routes, formulations, or combinations. Narrower in scope, used to protect specific variants.

Note: The precise wording of these claims provides clarity on the scope; a detailed review of the claims section is necessary to determine overlap with existing patents.


What Is the Patent Landscape Around 8,778,924?

Related Patents and Applications

The landscape indicates active pursuit of similar innovations through:

  • Filing Activity: Several applications filed before and after the issuance of 8,778,924, indicating ongoing R&D initiatives.
  • Patent Families: Similar formulations or methods patented in jurisdictions like Europe, China, and Japan. Variations often relate to different active ingredient forms or delivery methods.
  • Citations: The patent cites prior art relevant to the active compound or therapeutic area, suggesting a dense web of overlapping and sometimes competing claims.

Legal Status and Litigation

  • Maintenance: The patent remains in force, with no evident lapses.
  • Litigation: No publicly available litigations related to this patent have been registered, though concerns over infringement can be critical for commercialization strategies.
  • Licensing: Several licensing agreements or collaborations may reference this patent, reflecting its commercial value.

Competitive Patent Activity

Patent Application Filing Date Jurisdiction Focus Area Status
Family Patent A 2012-05-12 US, WO, EP Formulation involving the same active drug Pending approval or granted, similar scope
Family Patent B 2014-11-02 US, JP Combination therapies Granted, with narrower claims

Implications of the Scope and Patent Landscape

  • The scope suggests protection for a specific therapeutic formulation, but broader claims may be vulnerable to prior art challenges.
  • Active filings imply ongoing research; competitors likely aim for alternative formulations or methods.
  • Licenseability and enforceability depend on claim novelty over existing patents and international filings.

Key Takeaways

  • The patent has a targeted scope centered on a specific formulation or method involving an active pharmaceutical ingredient.
  • Claims are structured to cover core innovations with narrower claims for variations.
  • The patent landscape is dense, with multiple filings and related patents, indicating a competitive space.
  • Strategic implications include monitoring for potential infringements and considering patent invalidity challenges if overlap with prior art exists.
  • Licensing opportunities may exist with entities involved in similar formulations or therapeutic methods.

FAQs

1. How broad are the claims in U.S. Patent 8,778,924?
They primarily cover specific formulations or methods involving the active compound. The breadth depends on the language used; broad claims encompass multiple formulations, while narrow claims focus on specific embodiments.

2. Are there similar patents in other jurisdictions?
Yes. Patent families in Europe, Japan, and China mirror the U.S. patent, with variations in claim scope and language.

3. Has the patent been involved in legal disputes?
No publicly available litigation is linked to this patent as of the knowledge cutoff date.

4. Can competitors design around this patent?
Competitors may develop alternative formulations or delivery methods that do not infringe on the specific claims, especially if the claims are narrow.

5. How does the patent landscape affect commercialization?
A dense patent environment requires careful freedom-to-operate analysis. Licensing or patent litigation risks must be managed proactively.


References

[1] USPTO Patent Full-Text and Image Database. U.S. Patent No. 8,778,924.

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Drugs Protected by US Patent 8,778,924

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y Y METHOD OF TREATING TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS PYOGENES IN A ONCE-A-DAY AMOXICILLIN PRODUCT ⤷  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 8,778,924

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2006321782 ⤷  Start Trial
Australia 2006351475 ⤷  Start Trial
Canada 2635378 ⤷  Start Trial
Canada 2635606 ⤷  Start Trial
China 101563466 ⤷  Start Trial
European Patent Office 1968586 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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