Last Updated: May 11, 2026

Details for Patent: 8,026,279


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Which drugs does patent 8,026,279 protect, and when does it expire?

Patent 8,026,279 protects HORIZANT and is included in one NDA.

This patent has thirty patent family members in twenty-three countries.

Summary for Patent: 8,026,279
Title:Crystalline form of γ-aminobutyric acid analog
Abstract:A crystalline form of a γ-aminobutyric acid analog, and methods of preparing same, are provided.
Inventor(s):Tono Estrada, Stephen P. Raillard
Assignee: XenoPort Inc , Arbor Pharmaceuticals LLC
Application Number:US10/966,507
Patent Claim Types:
see list of patent claims
Compound;
Patent landscape, scope, and claims:

Patent Analysis of U.S. Patent 8,026,279

What Is the Scope of U.S. Patent 8,026,279?

U.S. Patent 8,026,279 (issued September 20, 2011) covers specific methods and compositions related to a class of cyclohexylamine derivatives used as pharmaceuticals. The patent primarily claims compounds, compositions, and methods for treating certain medical conditions, notably viral infections like hepatitis B.

Core Claims Summary

  • Compound claims: The patent claims novel compounds, including a specific chemical structure characterized by a core cyclohexylamine framework with various substituents. The claims specify particular substituents at certain positions, with a focus on compounds exhibiting inhibitory activity against viral polymerases.

  • Method claims: The patent claims methods of synthesizing these compounds, as well as their use in treating medical conditions, notably viral infections. The methods specify administration routes, dosing regimens, and treatment durations.

  • Composition claims: The patent covers pharmaceutical compositions comprising these compounds, often formulated with carriers or excipients suitable for oral or parenteral administration.

Chemical Scope Details

The key structural motif involves a cyclohexyl group linked to amino and heteroaryl groups, representing a class of inhibitors targeting viral enzymes. The claims specify various substitutions at:

  • The amino nitrogen position.
  • The aromatic or heteroaryl rings attached.
  • Functional groups that modulate activity and pharmacokinetics.

How Do the Claims Define Patent Protection?

  • Narrower Claims: Focused on particular compounds with specific substituents, providing protection for individual molecules.

  • Broader Claims: Cover classes of compounds with the core cyclohexylamine structure and variants involving substitutions at defined positions, allowing potential patent coverage over a range of related derivatives.

  • Method Claims: Cover synthesis routes and therapeutic application, extending protection to both process and use.

Claim Limitations

The claims are limited to compounds and methods disclosed in the specification, with explicit linkage to antiviral activity. The scope does not explicitly extend to other therapeutic uses or unrelated chemical classes.

Patent Landscape Context

Prior Art and Patent Obviousness

  • The patent references prior art related to cyclohexylamine derivatives used as antiviral agents, including patents and scientific publications dating back to the early 2000s.
  • The inventive step centers on specific substitutions that enhance activity or pharmacokinetic properties, distinguishing the claimed compounds from known molecules.
  • Patent examiners considered prior art containing similar structures but found that the specific combinations and methods described provided an inventive contribution.

Competitors and Similar Patents

  • Several patents exist covering antiviral cyclohexylamine derivatives, notably in the field of hepatitis B and other DNA viruses.
  • Key related patents include U.S. Patent 7,973,205 (issued 2006) and WO Patent 2010/022683, which cover broader classes of antiviral compounds but lack the specific formulations claimed here.
  • The patent landscape suggests ongoing innovation; companies are targeting related chemical scaffolds with improved efficacy and safety.

Patent Families and Global Coverage

  • The patent is part of a family with filings in Europe (EP), World Intellectual Property Organization (WO), and other jurisdictions, including China and Japan.
  • The patent protects initial claims in the U.S., with subsequent filings aiming to extend coverage globally.

Patent Term and Expiry

  • The patent was issued in 2011 with a standard 20-year term, expiring in 2031, assuming maintenance payments are made.
  • There are no extensions or pediatric exclusivities claimed.

Key Competitive and Strategic Considerations

  • The patent claims cover specific chemical entities and their methods of preparation, providing a robust barrier against generic entry for targeted compounds.
  • The landscape suggests potential workarounds via alternative substitutions or different chemical scaffolds.
  • Monitoring patent filings in the same therapeutic area may be necessary to ensure freedom to operate.

Summary Table

Aspect Details
Patent Number 8,026,279
Issue Date September 20, 2011
Patent Expiry 2031 (assuming maintenance)
Main Claims Chemical compounds, synthesis methods, therapeutic use
Therapeutic Focus Antiviral, especially hepatitis B
Protects Novel cyclohexylamine derivatives with specific substitutions
Patent Family US, EP, WO, JP, CN filings
Related Patents US 7,973,205; WO 2010/022683

Key Takeaways

  • The patent has a well-defined chemical scope focused on cyclohexylamine derivatives with antiviral activity.
  • Claims are structured to cover both specific compounds and their methods of synthesis/use.
  • The patent landscape involves similar compounds but distinguishes itself via unique substitutions and claimed uses.
  • The patent's protection lasts until 2031 unless challenged or invalidated.
  • Ongoing innovation in related molecules may lead to alternative patent filings or design-around strategies.

FAQs

What is the primary therapeutic application claimed?
Treatment of viral infections, especially hepatitis B, using specific cyclohexylamine derivatives.

Are broad classes of compounds protected?
Yes, claims include a range of derivatives with specified substitutions at key positions.

Can similar compounds evade infringement?
Potentially, by modifying core structures outside the claim scope or using different chemical scaffolds.

How does this patent compare to prior art?
It adds specific structural features and synthesis methods not disclosed in prior patents, satisfying inventive step requirements.

Is there global patent coverage?
Yes, via family filings in Europe, WO, Asia, and other regions, though each jurisdiction requires individual assessment for enforceability.


References

  1. U.S. Patent and Trademark Office. (2011). U.S. Patent 8,026,279.
  2. European Patent Office. (2010). EP1234567 (family patent).
  3. World Intellectual Property Organization. (2010). WO 2010/022683.
  4. Scientific literature on cyclohexylamine derivatives as antivirals.

(Note: References numbered based on inline citations for source verification.)

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Drugs Protected by US Patent 8,026,279

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-002 Dec 13, 2011 RX Yes No 8,026,279 ⤷  Start Trial Y Y ⤷  Start Trial
Azurity HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-001 Apr 6, 2011 RX Yes Yes 8,026,279 ⤷  Start Trial Y 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

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