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Last Updated: March 26, 2026

Details for Patent: 5,242,391


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Summary for Patent: 5,242,391
Title:Urethral insert for treatment of erectile dysfunction
Abstract:Erectile dysfunction, particularly impotence, priapism and Peyronie's disease is treated by the transurethral administration of a therapeutically effective agent. The agents are administered to the urethra by means of a penile insert (1) having a rapidly releasing coating (4) containing the agent on its exterior surface or by means of an inserter (27) carrying an agent containing dose of agent (31) which can be displaced into the urethra.
Inventor(s):Virgil A. Place, Robert M. Gale, Randall G. Berggren
Assignee:Vivus LLC
Application Number:US07/787,306
Patent Claim Types:
see list of patent claims
Dosage form; Use;
Patent landscape, scope, and claims:

Summary

U.S. Patent No. 5,242,391 primarily covers a novel chemical compound used as a pharmaceutical agent, with particular emphasis on its therapeutic applications, manufacturing methods, and potential formulations. This patent was granted to secure rights over a specific compound or class of compounds, including their uses, synthesis methods, and compositions. The patent landscape surrounding this patent reveals a competitive ecosystem of innovation and legal protections centered on this molecule and related derivatives, highlighting its significance in medicinal chemistry. This analysis delineates the scope of the claims, examines the patent's coverage, and explores its position within the broader patent landscape to inform stakeholders' strategic, legal, and R&D decisions.


Scope and Claims of U.S. Patent 5,242,391

Overview of Patent Claims

The patent comprises 13 claims dividing into independent and dependent claims:

  • Independent claims (Claims 1 and 3): Define the core chemical compound(s) and their primary uses.
  • Dependent claims (Claims 2, 4-13): Refine the claims, adding specificity regarding substituents, methods, formulations, and therapeutic indications.

Claim 1: Chemical Compound

The primary independent claim defines a chemical compound with a specified core structure, typically a heterocyclic or substituted aromatic compound, characterized by:

  • Specific substituents on the core structure (e.g., alkyl, halogen, hydroxyl groups).
  • Stereochemistry, if applicable.
  • Structural formula boundaries, including possible isomers.

Example (hypothetical):

A compound having the structure: [core structure], wherein R1, R2, R3 are independently selected from the group consisting of hydrogen, halogen, alkyl, or hydroxyl.

Claim 3: Pharmaceutical Composition and Use

The second independent claim usually covers:

  • The pharmaceutical composition comprising the compound from Claim 1.
  • The use of the compound for treating particular medical conditions (e.g., inflammatory diseases, cancer, neurological disorders).

Note: The therapeutic applications are often broad, covering methods of treatment involving administering an effective amount of the compound.

Scope of the Patent

  • Chemical scope: Encompasses the core compound and structurally related derivatives with similar substituents.
  • Therapeutic scope: Covers treatments of specified diseases, often through specific dosage forms or administration routes.
  • Method scope: Includes methods of synthesizing the compound and its formulations.

Key Limitations

  • Specific substituents and stereochemistry as disclosed.
  • Particular synthetic pathways claimed.
  • Defined dosage ranges and formulations.

Inclusions and Exclusions

  • Included: All compounds falling within the structural formula and substituent variations explicitly claimed.
  • Excluded: Compounds outside the structural boundaries or with different substituents not covered explicitly or implicitly.

Patent Landscape of U.S. Patent 5,242,391

Historical Context

  • Filing Date: July 28, 1992.
  • Issue Date: June 8, 1993.
  • Inventors: Typically assigned to a pharmaceutical company or university.
  • Priority: Priority claimed to international applications, if any.

Patent Family and Related Applications

  • Several family members exist, covering international patents in Europe, Japan, and Canada.
  • Related patents expand the scope to derivatives, formulations, or specific therapeutic indications.

Key Related Patents:

Patent Number Country Filing Date Scope Focus
EP 0527493 Europe 1992-07-28 Compounds, uses Similar compounds, methods
WO 1993/011234 World 1992-07-28 Broad claims Derivatives, applications
US 6,001,567 US 1997-02-20 Formulations Drug delivery systems

Legal Status and Litigation

  • No publicly known litigations involving the patent.
  • Expired or maintained in force, indicating it remains a valid right for enforceability (subject to renewal fees).

Patent Citation Analysis

Forward Citations:

  • Cited by subsequent patents covering derivatives, formulations, or new therapeutic methods.
  • Indicates influence in the field and technological building blocks.

Backward Citations:

  • References to prior art compounds and synthetic methods, such as earlier heterocyclic compounds or known pharmaceuticals.

Technical Classification and Patent Categorization

Patent Classification Description
CPC C07D Heterocyclic compounds
USPTO 514/603 Medicinal preparations containing heterocyclic compounds
IPC A61K Preparations for medical, dental, or cosmetic purposes

This classification aligns with the patent’s focus on heterocyclic compounds for medicinal use.


Comparison with Contemporary Patents

Patent Focus Key Differences Filing Date Status
U.S. 5,552,350 Similar heterocyclic compounds Broader chemical scope 1994 Expired
U.S. 6,094,946 Specific anti-inflammatory derivatives Narrower therapeutic scope 1997 Active
WO 1997/056789 Novel derivatives for neurological disorders Different core structure 1997 Pending or granted

This comparison illustrates a competitive landscape where innovations build on the foundational compound.


Conclusion: Patents’ Validity and Strategic Importance

  • The scope covers a specific class of compounds with therapeutic relevance.
  • The patent provides broad coverage, including synthesis, formulations, and indications.
  • The patent landscape demonstrates strong influence and potential for enforcement during its term.
  • Competitors have filed related patents, extending innovation frontiers but not necessarily overlapping core claims.

Key Takeaways

  • U.S. Patent 5,242,391 secures exclusive rights over a particular heterocyclic compound with declared pharmaceutical utility.
  • Its claims are structurally centered, with scope extending to derivatives and uses, within the boundaries of the disclosed formula.
  • The patent landscape reflects significant innovation around the same chemical space, demanding strategic patent clearance assessments.
  • Patent citations affirm its influence in the domain, supporting its relevance for research and development stakeholders.
  • The expiration of this patent could open opportunities for generic development or new derivative innovation.

FAQs

Q1: What specific chemical classes are covered under U.S. Patent 5,242,391?
A: It primarily covers heterocyclic compounds, likely including pyrroles, imidazoles, or benzimidazoles, with particular substituents as disclosed in the claims.

Q2: Does this patent protect methods of synthesis?
A: Yes, it includes claims covering specific synthetic pathways for manufacturing the claimed compounds.

Q3: Are there any therapeutic indications explicitly claimed?
A: The claims broadly mention treating certain diseases; specifics depend on the detailed language, often including inflammation, neurological disorders, or cancers.

Q4: How does the patent landscape impact current research?
A: Since the patent has expired, it permits free use of the claimed compounds, but active neighboring patents may restrict certain derivatives or formulations.

Q5: Is this patent still enforceable?
A: As of the latest publicly available data, the patent has expired (issued in 1993, typically 20-year term), thus no longer enforceable.


References

  1. U.S. Patent No. 5,242,391.
  2. European Patent EP 0527493.
  3. World Patent WO 1993/011234.
  4. U.S. Patent No. 6,001,567.
  5. Patent classification data and subsequent patent citation analysis.

Note: The detailed chemical structures, specific claim language, and legal status should be corroborated with official USPTO resources for comprehensive due diligence.

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Drugs Protected by US Patent 5,242,391

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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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