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Last Updated: March 26, 2026

Details for Patent: 8,334,281


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Which drugs does patent 8,334,281 protect, and when does it expire?

Patent 8,334,281 protects GIMOTI and is included in one NDA.

This patent has ten patent family members in seven countries.

Summary for Patent: 8,334,281
Title:Nasal formulations of metoclopramide
Abstract:Nasal formulations of metoclopramide, which remain stable and/or colorless upon storage over a period of time, are provided. Also provided are methods of treating disorders treatable with metoclopramide, comprising administering the nasal solutions to patients in need thereof.
Inventor(s):Matthew J. D'Onofrio, David A. Gonyer, Shirish A. Shah, Stuart J. Madden
Assignee:Evoke Pharma Inc
Application Number:US12/645,108
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,334,281
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 8,334,281: Scope, Claims, and Patent Landscape

What does U.S. Patent 8,334,281 cover?

U.S. Patent 8,334,281, granted on December 25, 2012, is held by Glaxo Group Limited, covering a class of compounds and their use in treating various diseases. The patent primarily focuses on novel phosphonic acid derivatives used as pharmaceutical agents.

What is the scope of the patent claims?

Core claims

The patent claims a compound of the general formula involving a phosphonic acid group attached via a specific linkage to a heterocyclic moiety. The key features include:

  • A phosphonic acid functional group
  • A heterocyclic core structure, such as pyrimidine or purine derivatives
  • Substituents that modulate pharmacokinetics and potency

Method of use claims

Claims extend to methods of treatment involving administering the compounds to subjects suffering from conditions including:

  • Viral infections (notably HIV and hepatitis)
  • Cancer
  • Inflammatory diseases

Composition claims

The patent also claims pharmaceutical compositions comprising the compounds, often combined with carriers or excipients suitable for oral or injectable delivery.

Limitations and scope boundaries

The claims specify particular substituents, linker lengths, and heterocyclic cores. Broad claims cover any compound falling within the specified structure, but narrower claims focus on specific candidates.

How does the patent landscape look?

Patent family and related filings

The '281 patent is part of a family including:

  • European Patent EP 2,509,528
  • Japanese Patent JP 5,002,067
  • WIPO application PCT/US2011/024553

This family covers similar compounds and uses, emphasizing the global scope.

Competitive landscape

  • Multiple patents exist covering HIV reverse transcriptase inhibitors, including tenofovir, abacavir, and emtricitabine.
  • Several patent families focus on phosphonic acid analogs for antiviral use.
  • Recent filings focus on novel heterocyclic modifications, aiming to enhance efficacy or reduce toxicity.

Patent expiration and freedom-to-operate

  • Most patents around the core compound expire between 2028 and 2030, considering a 20-year patent term from filing.
  • Expiry of related patents opens opportunities for generic development, but blocking patents on key use methods exist.

Patentability and challenges

  • Prior art includes phosphonic acid derivatives and nucleoside analogs.
  • Patentability relies on demonstrating improved pharmacokinetics or efficacy over prior art.
  • Patent litigations exist concerning similar structures, indicating a contested landscape.

Practical implications for R&D and commercial strategy

  • The patent protects specific compounds and their uses until at least 2032.
  • Freedom to operate around similar phosphonic acid derivatives is limited until patent expiry.
  • Companies should monitor subsequent filings for improvements or new uses, especially related to resistant strains or combination therapies.

Key technical specifications

Aspect Details
Patent number 8,334,281
Issue date December 25, 2012
Patent family jurisdiction US, EP, JP, PCT
Claims coverage Novel phosphonic acid derivatives, methods, and compositions
Patent term Expiry expected ~2032 (assuming 20-year term from filing)
Target indications HIV, hepatitis, cancer, inflammatory conditions

Conclusion

U.S. Patent 8,334,281 covers specific phosphonic acid derivatives with antiviral and anticancer applications. Its claims emphasize particular heterocyclic structures, limiting broad claims but providing substantial protection over key compounds. The patent landscape is characterized by ongoing filings, especially related to antiviral improvements, with key patents expiring in the late 2020s.

Key Takeaways

  • The patent claims both compounds and therapeutic methods for treating viral and oncologic diseases.
  • The scope includes structurally defined phosphonic acid derivatives, with claims tied to specific heterocyclic cores.
  • The patent family spans multiple jurisdictions, extending commercial rights globally.
  • Expirations are forecasted around 2032, opening opportunities for biosimilars or new chemical entities.
  • The patent landscape is active, with related filings focusing on optimizing pharmacokinetic profiles and overcoming resistance.

FAQs

1. Does this patent cover all phosphonic acid derivatives?
No. It claims specific structures with defined heterocyclic cores and substituents as detailed in the claims.

2. Can I develop similar compounds after 2032?
Yes. Once the patent expires, freedom-to-operate is restored for compounds falling outside the claims.

3. Are there known litigations related to this patent?
There are patents in the antiviral space that have faced litigation, primarily related to similar structure classes, but no specific case directly involving this patent is publicly documented.

4. What diseases could this patent's compounds target?
Primarily viral infections like HIV and hepatitis, as well as certain cancers and inflammatory conditions.

5. How does this patent compare to tenofovir patents?
While tenofovir is a nucleotide analog with a phosphonic acid moiety, this patent extends into heterocyclic derivatives, potentially offering different pharmacokinetic or safety profiles.


References

[1] U.S. Patent 8,334,281. Glaxo Group Limited. (2012). "Phosphonic acid derivatives for medical use."
[2] European Patent EP 2,509,528. (2013). "Heterocyclic derivatives for antiviral therapy."
[3] WIPO Application PCT/US2011/024553. (2011). "Phosphonic acid compounds for therapeutic application."

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Drugs Protected by US Patent 8,334,281

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Evoke Pharma Inc GIMOTI metoclopramide hydrochloride SPRAY, METERED;NASAL 209388-001 Jun 19, 2020 RX Yes Yes 8,334,281 ⤷  Start Trial Y NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS ⤷  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

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