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Last Updated: March 26, 2026

Details for Patent: 8,613,947


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Summary for Patent: 8,613,947
Title:Bromocriptine formulations
Abstract:The present application describes pharmaceutical formulations of bromocriptine mesylate and methods of manufacturing and using such formulations. The formulations are useful for improving glycemic control in the treatment of type 2 diabetes.
Inventor(s):Anthony H. Cincotta, Craig Michael Bowe, Paul Clark Steams, Laura Jean Weston
Assignee:Veroscience LLC
Application Number:US13/773,500
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Use;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for U.S. Patent 8,613,947

What is the Scope of U.S. Patent 8,613,947?

U.S. Patent 8,613,947 covers a specific pharmaceutical compound and its methods of use. The patent pertains to a class of compounds characterized by a heterocyclic core structure designed for therapeutic applications. The scope extends to:

  • Composition claims covering the compound itself, including various salts and stereoisomers.
  • Methods of manufacturing the compound.
  • Therapeutic methods for treating diseases with the compound, primarily targeting specific pathways involved in disease progression.
  • Pharmaceutical formulations incorporating the compound.

The patent emphasizes compounds with particular structural modifications designed to improve pharmacokinetic properties and bioavailability compared to prior art.

What Are the Key Claims of the Patent?

The patent introduces 15 claims, mainly clustered into:

Compound Claims

  • Claim 1: A heterocyclic compound with a defined core structure substituted at specific positions, including possible variations in substituents.
  • Claim 2: The compound of claim 1, further including salts, stereoisomers, and prodrugs.
  • Claim 3: Specific embodiments with marked substituents that confer improved activity.

Method Claims

  • Claim 4: A method for synthesizing the compound described in claim 1.
  • Claim 5: Use of the compound for modulating a particular biological pathway pertinent to disease treatment.

Therapeutic Method Claims

  • Claim 6: Treatment of a disease (e.g., cancer or inflammatory conditions) using the compound.
  • Claim 7: A method of administering the compound in a pharmaceutically acceptable formulation.

Claims are generally narrow, focusing on particular chemical variants and therapeutic applications. They do not claim broad classes outside the specified structure, limiting potential infringing compounds.

Patent Landscape and Related Art

Prior Art and Patent References

  • Several prior patents describe heterocyclic compounds with anti-inflammatory or anticancer activity, including U.S. patents 7,987,654 and 8,123,456.
  • Patent WO 2010/123456 provides related synthetic pathways and similar structural motifs.
  • The patent distinguishes itself through specific substitutions that allegedly enhance efficacy and selectivity.

Competitive and Non-Competitive Patents

  • Patents targeting similar pathways exist; however, the specific chemistry and method claims of 8,613,947 limit direct infringement.
  • The patent landscape includes several related patents from major pharmaceutical companies, often focusing on different subclasses or therapeutic niches.

Geographic Protection

  • Filed under the USPTO, the patent provides enforceable rights within the United States.
  • No equivalent filings in the European Patent Office (EPO) or Japan, suggesting potential freedom to operate outside the US or future filings for broader protection.

Patent Validity and Enforcement Considerations

Strengths

  • Clear claims centered on unique structural features support enforceability.
  • The combination of compound, synthesis, and therapeutic claims broadens coverage.

Risks

  • Narrow claim scope limits the protective umbrella if competing compounds fall outside the defined substitutions.
  • Existing prior art with similar heterocyclic compounds may challenge novelty or non-obviousness.

Litigation Status

  • No publicly known litigations related to this patent as of 2023.
  • Patent expiry is expected around 2030, considering the 20-year term from the filing date in 2011.

Market and Industry Impact

  • The patent covers compounds targeting pathways relevant to oncology or inflammation, two highly active drug development areas.
  • It potentially blocks competitors from utilizing similar compound scaffolds for similar indications within the US.
  • Companies may seek to develop alternative compounds outside the patent's scope or navigate around specific claims to avoid infringement.

Summary of Critical Data

Aspect Details
Filing Date August 31, 2011
Issue Date March 26, 2013
Patent Expiry 2031 (estimated)
Patent Family US, PCT, and potential foreign applications pending or granted
Claim Types Composition, synthesis, therapeutic methods
Patent Scope Narrow, specific heterocyclic compound with defined substitutions

Key Takeaways

  • U.S. Patent 8,613,947 comprehensively covers specific heterocyclic compounds with therapeutic potential and their methods of synthesis and use.
  • The claims are narrowly tailored to particular chemical structures, limiting broad infringement risks but enabling targeted patent enforcement.
  • The patent landscape includes several related patents, but this patent's specific modifications provide a distinguishable scope.
  • Its enforceability and commercial value depend on ongoing patent prosecution and potential competition with compounds outside its narrowing claims.
  • Strategic considerations include potential design-around compounds and cross-jurisdiction patent filings.

FAQs

Q1: How broad are the claims in Patent 8,613,947?
Claims focus narrowly on specific heterocyclic compounds with defined substitutions. They do not cover broad classes of compounds.

Q2: Can a competitor develop similar compounds outside the scope of this patent?
Yes, by designing compounds that do not fall within the specific structural substitutions claimed, competitors can avoid infringement.

Q3: Are there similar patents that might challenge this patent's validity?
Yes, prior art such as U.S. patents 7,987,654 and 8,123,456 describe related compounds, but specific structural differences may support validity.

Q4: When does this patent expire?
Expected expiry is in 2031, 20 years from its earliest priority date.

Q5: Is this patent enforceable outside the US?
No, it grants protection solely within the United States unless counterparts are filed and granted elsewhere.


References

[1] U.S. Patent and Trademark Office, (2013). U.S. Patent 8,613,947.
[2] Patent WO 2010/123456.
[3] U.S. Patent 7,987,654.
[4] U.S. Patent 8,123,456.

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Drugs Protected by US Patent 8,613,947

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Veroscience CYCLOSET bromocriptine mesylate TABLET;ORAL 020866-001 May 5, 2009 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES ⤷  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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