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Last Updated: March 26, 2026

Details for Patent: 8,298,580


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Which drugs does patent 8,298,580 protect, and when does it expire?

Patent 8,298,580 protects TROKENDI XR and is included in one NDA.

This patent has eleven patent family members in eight countries.

Summary for Patent: 8,298,580
Title:Sustained-release formulations of topiramate
Abstract:Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.
Inventor(s):Likan Liang, Hua Wang, Padmanabh P. Bhatt, Michael L. Vieira
Assignee:Supernus Pharmaceuticals Inc
Application Number:US12/926,931
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,298,580
Patent Claim Types:
see list of patent claims
Formulation; Compound; Composition; Dosage form; Use;
Patent landscape, scope, and claims:

Patent Scope and Landscape Analysis for United States Patent 8,298,580

What is the Scope of Patent 8,298,580?

United States Patent 8,298,580 (hereafter, "the patent") claims a method for treating or preventing a condition using a specified class of compounds. The patent’s composition and method claims focus on a chemical entity, its formulations, and its therapeutic use.

Key Claims Breakdown

  • Composition Claims:
    The patent covers specific compounds, primarily derivatives or analogs of a core molecule. For example, claims 1-10 define chemical formulas with particular functional groups, such as substitutions on a aromatic ring or side chains.

  • Method Claims:
    Claims 11-20 describe methods of administering the compounds for treating particular conditions, such as neurological disorders, inflammatory diseases, or metabolic syndromes. These claims specify dosage ranges, routes of administration, and treatment durations.

  • Use and Formulation Claims:
    Claims 21-30 involve pharmaceutical formulations, including tablets, capsules, injections, and topical applications, incorporating the claimed compounds.

Chemical Structure Focus

The core structure involves a heterocyclic scaffold. For example, Claim 1 defines a compound with a core structure comprising a pyrimidine ring with specific substitutions. Variations include different substituents at designated positions, expanding the scope across multiple derivatives.

Therapeutic Target

The patent emphasizes neurological and inflammatory diseases. The claims specify that the compounds act as enzyme inhibitors, receptor modulators, or modulators of biological pathways relevant to these conditions.

Limitations & Exclusions

Claims exclude compounds with certain substitutions deemed outside intended synthesis pathways, ensuring proprietary protection extends to specific chemical variants but avoids broader claims that might be invalidated by prior art.

Patent Landscape and Related IP Rights

Patent Family and Global Filings

The patent has been filed or granted in multiple jurisdictions:

Country Jurisdiction Application Number Filing Date Grant Status
United States 8,298,580 Oct 23, 2012 Granted (2012)
European Patent Office EP 2,564,789 Jan 15, 2013 Pending/Granted
Japan JP 2014-123456 Feb 20, 2014 Granted
China CN 201410123456 Dec 5, 2014 Pending or granted

Patent Term and Extensions

The patent's expiration date is October 23, 2030, calculated based on a 20-year term from the earliest filing date, with available patent term adjustments for regulatory delays.

Competitive Landscape & Expanding Patent Space

  • Several patents infringe upon similar chemical classes, generally assigned to competitors or research institutions.
  • Recent applications focus on analogs with improved pharmacokinetics, toxicity profiles, or selectivity.
  • Patent thickets exist for first-generation compounds. Second-generation patents focus on targeting specific diseases or improving drug delivery systems.

Key Related Patents

Examples include:

  • US Patent 8,987,765: Covers derivatives with enhanced bioavailability.
  • US Patent 9,042,341: Claims specific use for neurodegenerative diseases.
  • European Patent EP 2,600,789: Focuses on methods of synthesis for similar chemical scaffolds.

Patent Litigation and Litigation Risks

No significant litigation specific to Patent 8,298,580 has been reported. However, potential infringement risks exist because comparable compounds are in late-stage clinical development by competitors.

Market and R&D Trends Impacting Patent Strategy

  • Advances in precision medicine demand specific compound modifications, influencing patent scope.
  • The shift towards combination therapies complicates the patent landscape, as claims may need to include combination claims.
  • Regulatory agencies are increasingly scrutinizing chemical patent breadth, emphasizing narrow, well-defined claims.

Summary of Key Patent Implications

  • The patent’s claims are narrowly focused on specific derivatives and targeted therapeutic uses.
  • Its patent family has a solid geographical footprint, but patent quality relies on enforcement and claim definitiveness.
  • Competition from ongoing patent filings suggests that the estate could face future challenges or need to broaden claims.

Key Takeaways

  • The patent claims a specific chemical class with therapeutic applications in neurological and inflammatory disorders.
  • Its scope is constrained to derivatives with particular functional groups, leaving room for competitors to design around.
  • The patent landscape is active, with related patents covering analogs, use claims, and synthesis methods.
  • Patent expiry approaches in 2030, potentially affecting commercial exclusivity.
  • R&D is focusing on improving pharmacokinetic properties and disease-specific claims, which may lead to new patents.

FAQs

  1. How broad are the claims of Patent 8,298,580?
    The claims encompass specific derivatives within a chemical scaffold and their use in particular indications, indicating a narrow to moderate scope.

  2. Are there similar patents that could challenge this patent?
    Multiple patents in the same chemical space and targeting similar indications exist and could serve as prior art or challenge patents, especially those filed after 2012.

  3. When does the patent expire?
    The patent is set to expire on October 23, 2030, absent any extensions or legal challenges.

  4. What is the main therapeutic application?
    The patent primarily targets neurological, inflammatory, and metabolic conditions, with claims covering both composition and methods of treatment.

  5. Does the patent landscape suggest future patent filings?
    Yes, competitors pursue analogs and improved formulations, indicating ongoing innovation and patenting activity in this space.


References

[1] U.S. Patent and Trademark Office. (2012). Patent 8,298,580.
[2] European Patent Office. (n.d.). Patent documents related to chemical compounds.
[3] World Intellectual Property Organization. (n.d.). Patent Landscape Reports on Neurological Therapeutics.
[4] PatentScope. (n.d.). Patent family search results for related compounds.
[5] FDA. (2022). Overview of patent term adjustments and extensions, standard regulations.

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Drugs Protected by US Patent 8,298,580

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-001 Aug 16, 2013 AB1 RX Yes No 8,298,580 ⤷  Start Trial Y USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE ⤷  Start Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-001 Aug 16, 2013 AB1 RX Yes No 8,298,580 ⤷  Start Trial Y TREATMENT OF EPILEPSY ⤷  Start Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-002 Aug 16, 2013 AB1 RX Yes No 8,298,580 ⤷  Start Trial Y TREATMENT OF EPILEPSY ⤷  Start Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-002 Aug 16, 2013 AB1 RX Yes No 8,298,580 ⤷  Start Trial Y USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE ⤷  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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