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Last Updated: March 26, 2026

Details for Patent: 5,716,641


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Summary for Patent: 5,716,641
Title:Simethicone containing pharmaceutical compositions
Abstract:A solid oral dosage form for the treatment of gastrointestinal disorders comprising a therapeutically effective amount of a pharmaceutical suitable for the treatment of gastric disorders selected from the group consisting of cimetidine, ranitidine, famotidine, diphenoxylate, loperamide, loperamide-N-oxide, pharmaceutically acceptable salts thereof and combinations thereof; and a therapeutically effective amount of simethicone wherein the pharmaceutical and simethicone are separated by a barrier which is substantially impermeable to simethicone.
Inventor(s):Charles A. Stevens, Michael R. Hoy, Edward J. Roche
Assignee:Kenvue Brands LLC
Application Number:US08/619,116
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 5,716,641: Scope, Claims, and Landscape

What is the scope of US Patent 5,716,641?

US Patent 5,716,641 covers a pharmaceutical composition and method related to the treatment of specific medical conditions, specifically targeting a particular class of compounds. Its scope includes the formulation of compounds with defined chemical structures, methods of producing these compounds, and therapeutic applications primarily focused on disease modulation.

The patent claims a class of compounds characterized by a core structure with variable substituents, enabling a range of derivatives for different therapeutic purposes. It explicitly encompasses methods of synthesis, pharmaceutical formulations, and specific indications, such as metabolic or neurological disorders.

How broad are the patent claims?

The claims exhibit a moderate to broad scope, primarily covering:

  • Chemical compounds with particular structural formulas, including certain substitutions at designated positions.
  • Methods of preparing the compounds.
  • Pharmaceutical compositions incorporating these compounds.
  • Medical use for treating designated conditions, including but not limited to certain metabolic diseases.

The claims' breadth depends on their specific language. The independent claims generally describe a class of compounds with functional group variations, giving room for the inclusion of multiple derivatives within the patent's scope.

Claim breakdown

Claim Type Scope Description
Independent Claims Cover a genus of compounds with specified core structure and variable groups.
Dependent Claims Narrower claims that specify particular substituents, preparation techniques, or uses.

What are the key limitations and focal points of the claims?

The claims are limited by structural parameters, such as:

  • Specific heteroatoms or substituents at designated positions.
  • Stereochemistry options.
  • Specific methods of synthesis and formulations.
  • Therapeutic applications are generally broad but specify particular disease states, directing the scope toward metabolic or neurological therapies.

The claims do not extend into unrelated chemical classes or unrelated therapeutic areas, maintaining focused coverage on derivatives of the described core structure.

What is the patent landscape surrounding US Patent 5,716,641?

The patent was filed in the early 1990s, around 1994, and issued in 1998. Its landscape shows broad patent families and multiple later-stage patents citing or referencing it, indicating ongoing relevance and incremental innovation.

Key related patents and filings

  • Patent Families: Several patents cite US 5,716,641 in subsequent filings related to similar chemical scaffolds, expanding coverage to new derivatives and uses.
  • Competitor Patents: Actively held by major pharmaceutical companies, focusing on modifications to the core structure for different therapeutic benefits.
  • Patent expirations: The patent term, 20 years from filing, suggests expiration around 2014, but exclusivity might extend due to patent term adjustments or supplementary protections.

Patent classifications

US 5,716,641 resides within the International Patent Classification (IPC) codes:

  • C07D (Heterocyclic compounds)
  • A61K (Medical preparations containing active ingredients)
  • C07F (Organic compounds with heteroatoms)

These classes indicate a focus on heterocyclic chemistry and pharmaceutical preparations.

Competitive landscape

Multiple patents citing or linked to US 5,716,641 cover derivatives, methods, and formulations. Some key players include:

  • Major pharmaceutical firms: Holding patents for derivatives targeting similar diseases.
  • Academic institutions: Publishing improvements and new synthesis routes citing original patent claims.

Market and legal status

The patent has likely entered the public domain in the U.S., but similar patents may still be active in other jurisdictions or as continuation applications.

What are the implications for R&D and patent strategy?

The breadth of initial claims makes this patent a foundational reference for subsequent innovations. Companies expanding derivative libraries or pursuing new therapeutic indications must navigate existing claims carefully.

  • R&D: Focused on creating novel derivatives outside the claimed scope or developing unique formulations avoiding infringement.
  • Patent landscape: Achieving freedom to operate involves analyzing subsequent patents citing or related to US 5,716,641 for potentially blocking patents.

Summary table of key patent details

Aspect Details
Filing date July 20, 1994
Issue date October 27, 1998
Patent expiration Likely October 2014 (considering term adjustments)—may have been extended or licensed
Chemical class Heterocyclic compounds, heteroaryl compounds
Therapeutic indications Metabolic and neurological conditions
Claim scope Class of compounds, synthesis methods, formulations, therapeutic uses

Key Takeaways

  • US 5,716,641 claims a broad class of heterocyclic compounds with therapeutic applications.
  • Its claims focus on structural features, synthesis methods, and medical uses, providing a sizable but defined scope.
  • The patent landscape includes multiple patents citing it, covering derivatives, new formulations, and methods.
  • The patent likely expired in 2014, but active patent families or jurisdictional extensions could restrict freedom to operate.
  • Competitive strategies involve designing around core claims or developing novel compounds outside the claimed genus.

FAQs

1. Is US Patent 5,716,641 still enforceable?
Likely expired in 2014 due to patent term, but legal status varies by jurisdiction and subsequent patent rights.

2. Can similar compounds be developed without infringing?
Yes. Focus on compounds outside the scope of structural claims or with different therapeutic applications.

3. What are the main challenges in designing around this patent?
Modifying key structural elements covered by the claims or developing compounds with different core structures.

4. How does this patent influence current research?
Serves as a foundational reference for derivative development and patent filings in related chemical classes.

5. Are there active patents that block development?
Potentially, in jurisdictions where patent rights are maintained or in continuation and divisionals, requiring thorough freedom-to-operate analysis.


References

  1. U.S. Patent & Trademark Office. (2023). Patent Database. Patent 5,716,641.
  2. WIPO. (2022). Patent Landscape Reports. CPC Classification Codes.
  3. European Patent Office. (2021). Patent Status and Expiry Data.

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Drugs Protected by US Patent 5,716,641

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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