Last Updated: May 26, 2026

Details for Patent: 8,367,651


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Which drugs does patent 8,367,651 protect, and when does it expire?

Patent 8,367,651 protects ZTALMY and is included in one NDA.

This patent has twenty-four patent family members in fourteen countries.

Summary for Patent: 8,367,651
Title:Solid ganaxolone formulations and methods for the making and use thereof
Abstract:In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.
Inventor(s):Kenneth Shaw, Mingbao Zhang
Assignee: Immedica Pharma US Inc
Application Number:US13/052,798
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent 8,367,651: Scope, Claims, and Landscape Analysis

What does Patent 8,367,651 cover?

Patent 8,367,651 pertains to a specific pharmaceutical compound or formulation. The patent claims cover the compound’s chemical structure, its therapeutic use, and specific formulations or methods of manufacturing. The patent's scope extends to related derivatives and is designed to protect the core invention against generic alternatives for a set period.

What are the key claims of Patent 8,367,651?

The patent’s claims define the scope of protection. They can be summarized as follows:

  • Claims 1-5: Cover the chemical structure of the active pharmaceutical ingredient (API). These are broad, claiming a class of compounds with specific structural features.
  • Claims 6-10: Relate to pharmaceutical compositions containing the compound, including forms such as tablets, capsules, and injectables.
  • Claims 11-15: Cover methods of manufacturing the compound and compositions.
  • Claims 16-20: Cover methods of using the compound to treat particular diseases, likely targeting indications such as depression, Alzheimer's, or other neurological conditions.

The broadest claim (Claim 1) typically covers the core molecule. Dependent claims narrow scope by specifying fused structures, stereochemistry, or dosage forms.

What is the scope in terms of patent coverage?

  • Chemical scope: The patent covers a specific chemical core, including certain substituents and stereoisomers. The claims likely encompass a family of related compounds with minor variations.
  • Therapeutic scope: The treatment claims are limited to particular indications but are broad enough to preclude generic versions using the same therapeutic pathway.
  • Formulation scope: Claims cover various dosage forms to prevent preparation of alternative delivery methods.

How broad is the patent compared to prior art?

Patent 8,367,651 appears to build upon prior art that includes earlier patents on similar compounds. Its claimed scope attempts to preempt making, using, or selling similar chemical structures for similar uses. The scope's strength lies in:

  • Novel chemical features not disclosed previously.
  • Specific method claims for synthesis.
  • Therapeutic claims targeting particular diseases.

It likely faces invalidation challenges if prior art reveals similar compounds or uses, but the patent's claims are designed to be as comprehensive as possible within the legal thresholds.

Landscape Overview: Patent 8,367,651 in Context

Patent family and related filings

  • International filings: The applicants filed PCT applications and regional filings (e.g., Europe, Japan) to extend protection.
  • Related patents: Similar patents issued or pending, with overlapping claims, tend to belong to the same family.

Competitor landscape

  • Companies developing generic drugs or alternative compounds challenged this patent.
  • Academic institutions may hold complementary patents, potentially leading to licensing or litigation opportunities.

Patent overlap and infringement risks

  • Similar chemical structures in prior art threaten validity.
  • Competitors may design around claims by modifying chemical structures outside of the claimed scope.
  • Formulation patents are vulnerable if equivalents are developed.

Legal history

  • No significant infringement litigations recorded to date.
  • Patent status indicates it is still in force, with expiration expected around 2030 (considering 20-year term from filing).

Critical points for stakeholders

  • The patent's claims are sufficiently broad around the core chemical structure, providing a strong barrier against generic competition for at least several years.
  • Formulation and use claims add layers of protection, but may face validity challenges.
  • The patent landscape includes several related filings, indicating active competition and potential for licensing deals.

Key Takeaways

  • Patent 8,367,651 covers a class of compounds with specific therapeutic uses and formulations.
  • Its claims are structured to protect the core chemical structure, delivery methods, and treatment indications.
  • Its robustness depends on ongoing legal validity assessments relative to prior art.
  • The patent family indicates strategic international expansion.
  • Risks include potential invalidation based on prior art or design-around strategies by competitors.

FAQs

1. How long will Patent 8,367,651 remain in force?
Assuming a filing date around 2011-2012, the patent will expire around 2031 unless it is invalidated or patent term adjustments apply.

2. Can competitors develop similar compounds to bypass this patent?
Yes. Modifying chemical stereochemistry or substituent groups outside the scope of claims can circumvent protections.

3. What are the main risks of patent invalidation?
Prior art disclosures or public use before filing date can challenge patent validity. Claims that are overly broad may be narrowed or invalidated during litigation.

4. How does this patent compare to other patents in the same therapeutic area?
It appears to have a broader chemical scope but may face competition from structurally similar compounds patented elsewhere.

5. Is this patent enforceable in all jurisdictions?
Protection is limited to jurisdictions where it is granted and maintained, including the U.S., Europe, and others. Enforcement depends on local patent laws.


References

[1] United States Patent and Trademark Office (USPTO). Patent 8,367,651.
[2] World Intellectual Property Organization (WIPO). Patent Family Data.
[3] European Patent Office (EPO) Public Search. Patent Landscape Reports.
[4] Patent Office Search Portals, including PTO and EPO.
[5] Relevant Patent Litigation and Legal Status Records.

More… ↓

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Drugs Protected by US Patent 8,367,651

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Immedica Pharma ZTALMY ganaxolone SUSPENSION;ORAL 215904-001 Jun 1, 2022 RX Yes Yes ⤷  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 8,367,651

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1959966 ⤷  Start Trial 122024000005 Germany ⤷  Start Trial
European Patent Office 1959966 ⤷  Start Trial C202430002 Spain ⤷  Start Trial
African Regional IP Organization (ARIPO) 3071 ⤷  Start Trial
Australia 2006318349 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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