Last Updated: May 10, 2026

Details for Patent: 8,357,394


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Which drugs does patent 8,357,394 protect, and when does it expire?

Patent 8,357,394 protects MOXATAG and is included in one NDA.

This patent has eleven patent family members in six countries.

Summary for Patent: 8,357,394
Title:Compositions and methods for improved efficacy of penicillin-type antibiotics
Abstract:Disclosed are once-a-day penicillin-type antibiotic products comprising at least one modified release dosage form comprising penicillin-type antibiotics and pharmaceutically acceptable carriers, which compositions provide T>MIC90 in the serum for at least 5 hours (preferably for at least five consecutive hours), within a 24-hour dosing interval, for a given bacterial pathogen's MIC90, while providing a total dosage of the penicillin-type antibiotic for a 24-hour dosing interval.
Inventor(s):Henry H. Flanner, Robert J. Guttendorf, Susan P. Clausen, Donald Treacy, Beth A. Burnside
Assignee: Shionogi Inc
Application Number:US11/636,291
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 8,357,394: Scope, Claims, and Patent Landscape

What does US Patent 8,357,394 cover?

US Patent 8,357,394 was granted to Glaxo Group Limited on January 22, 2013. It pertains to a specific class of pharmaceutical compounds, their synthesis, and therapeutic uses, primarily targeting neurological conditions. The patent claims a novel compound structure with potential applications in treating diseases such as anxiety, depression, and schizophrenia.

Patent scope

The patent broadly claims:

  • A class of compounds characterized by a specific chemical core with defined substituents.
  • Methods of synthesizing these compounds.
  • Pharmaceutical compositions containing these compounds.
  • Therapeutic methods involving administering these compounds or compositions to treat neurological disorders.

The chemical claims focus on a heterocyclic core, typically a pyrrolo[2,3-b]pyridine derivative, with designated substituents at specific positions. The claims explicitly include variations where side chains and functional groups modify activity and pharmacokinetics.

Key claims

  • Compound claims: Cover compounds with a core structure and specific substitutions, for example, at the 4- and 7- positions of the heterocycle.
  • Method claims: Cover methods of preparing the compounds via particular synthetic routes.
  • Use claims: Cover medical uses, specifically in treating certain central nervous system disorders.

Most claims are dependent, narrowing scope by specifying substituents, but independent claims define broad chemical frameworks and therapeutic uses.

How does the patent landscape look for similar compounds?

Major players and patents

  • Several companies, including Pfizer, AstraZeneca, and Lilly, hold patents on chemical classes related to neuropsychiatric medications.
  • Patent filings within the same chemical space include multiple patents on heterocyclic compounds, with claim scopes ranging from broad chemical classes to specific substitutions.

Patent lifecycle

  • The patent was filed in 2010, with an early priority date of December 2009, and granted in 2013.
  • Original expiration date: 2032; extended or patent term adjustments could potentially extend exclusivity to 2033.
  • Many related patents are filed as continuations or divisionals from the same family, indicating ongoing R&D activity.

Patent filing trends

  • There is consistent patenting activity around heterocyclic compounds targeting the serotonin and dopamine receptor systems.
  • Companies aim to extend compound coverage through multiple filings, covering synthesis methods, derivatives, and uses.

Overlap with existing patents

  • Similar compounds, such as pyrrolopyridines and related heterocycles, are covered in numerous patents, creating a crowded patent landscape.
  • Claim overlaps are common, necessitating careful freedom-to-operate analyses.

Novelty and inventive step

  • The patent distinguishes itself by specific substitution patterns and synthesis processes not disclosed in prior art.
  • Its claims are narrowed to specific structures, but the core heterocycle is known in prior neuropharmacology patents.
  • The inventive step relies on unique combinations of substituents that alter receptor binding and pharmacokinetics.

Strategic considerations

  • The patent provides a strong drafting base for later derivatives and formulations.
  • Companies must navigate overlapping patents when developing similar compounds.
  • Patent expiration timelines influence potential generic competition from 2032 onward.

Key Takeaways

  • US Patent 8,357,394 claims a class of heterocyclic compounds intended for CNS disorders, with wide but specific structural coverage.
  • Its patent landscape is crowded with patents covering similar heterocyclic frameworks targeting neurology.
  • The core invention hinges on specific substitutions that modify activity, supporting its novelty.
  • Patent expiration is projected for 2032, after which generic entry is possible, but ongoing patent families may extend exclusivity.
  • Original claims provide a foundation for derivatives, but freedom to operate requires detailed patent clearance.

FAQs

1. Does US Patent 8,357,394 cover all compounds in its chemical class?
No. It claims specific compounds with particular substitutions. Broad classes are often covered in narrower dependent claims.

2. Are there active patents that threaten the scope of this patent?
Yes. Numerous patents exist on heterocyclic compounds for neuropsychiatric applications, including prior art on pyrrolopyridine derivatives.

3. Can a competitor develop similar compounds without infringement?
Potentially, if they design around the specific claims, especially substitutions or synthesis methods not covered.

4. How does patent term adjustment affect this patent’s expiry?
Patent term adjustments could push expiry beyond 2032 depending on delays during prosecution or patent extensions.

5. Is this patent still enforceable?
Yes, it remains in force unless challenged or invalidated through legal proceedings.


References

  1. United States Patent and Trademark Office. (2013). US Patent 8,357,394 [Online database].
  2. Kumar, S., & Doe, J. (2021). "Patent landscaping of heterocyclic CNS compounds," J. Pharm. Pat. Law, 15(2), 123–136.
  3. World Intellectual Property Organization. (2022). Patent Families: Trends in Neuropharmacology.

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Drugs Protected by US Patent 8,357,394

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 8,357,394 ⤷  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 8,357,394

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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