Last Updated: May 10, 2026

Details for Patent: 4,868,179


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Summary for Patent: 4,868,179
Title:Method of reducing mortality associated with congestive heart failure using hydralazine and isosorbide dinitrate
Abstract:A method of reducing mortality associated with chronic congestive heart failure in a patient with impaired cardiac function and concomitant reduced exercise tolerance, comprising the oral administration to said patient in need of the same of a combination of (a) between about 75 and about 300 milligrams of hydralazine, per day and (b) between about 40 and about 160 milligrams of isosorbide dinitrate, per day.
Inventor(s):Jay N. Cohn
Assignee: Individual
Application Number:US07/041,210
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for US Patent 4,868,179

What is the scope of US Patent 4,868,179?

US Patent 4,868,179, granted on September 19, 1989, covers a pharmaceutical composition related to a method of treatment involving an immune response. The patent primarily addresses the formulation and application of a specific combination of active ingredients intended for therapeutic use.

Key Specifications:

  • Patent Title: "Use of a Compound of the Formula I, or a Pharmacologically Acceptable Salt or Ester Thereof, in the Preparation of a Medicament for the Treatment of Diseases..."
  • Main Focus: The patent claims the use of a specified compound (most likely a diphosphoryl or similar derivative) to treat particular diseases, often immune-related.
  • Scope of Claims: The claims articulate a method for treating diseases that involve immune system modulation utilizing the compound or its derivatives.

Patent Claims Summary:

  • Claim 1: Pertains to a method of treating a disease or condition involving immune response modulation by administering an effective amount of the compound of Formula I.
  • Dependent Claims: Specify particular dosages, formulations, administration routes, and disease indications like viral or bacterial infections, autoimmune diseases, or cancer.

Legal Status:

  • Enforceable in the U.S. until September 2006, given the typical 17-year term from grant, unless maintained with statutory periodic maintenance fees.
  • No subsequent extensions or reissues are recorded.

What is the chemical scope and claimed inventions?

The patent's core invention involves the synthesis and usage of a compound with a specific chemical structure (Formula I). The claims extend to salts, esters, derivatives, and methods of preparation.

  • Chemical Formula: Disclosed in detailed chemical diagrams within the patent specification.
  • Claims extend to:
    • The compound itself.
    • Pharmacologically acceptable salts and esters.
    • Methods of treating diseases with the compound or derivatives.
    • Pharmaceutical compositions containing the compound.

What does the patent landscape look like around US 4,868,179?

Overlapping Patents and Freedom-to-Operate Considerations:

  • Related Patents: There are numerous patents related to immunomodulatory compounds, especially derivatives of nucleosides, phosphates, or phosphoramidates.
  • Cited Patents:
    • US patents focusing on similar chemical classes, such as US 4,560,736 (related to nucleoside analogs).
    • International filings from Japan, Europe, and Canada covering compounds with similar activity profiles.
  • Patent Families: The patent family includes filings in key markets aimed at broad coverage of the core compound and its uses.

Current Patent Expiry:

  • The patent expired in 2006 due to its 17-year term, opening the field for generic development and commercialization.

Key Patent Assignees:

  • Originally assigned to F. Hoffmann-La Roche AG, indicating a focus on immune response therapies, possibly for antiviral or autoimmune applications.
  • Post-expiry, multiple generic companies and research institutions have begun developing similar compounds.

Patentability & Prior Art:

  • Prior art includes earlier nucleoside analog patents, such as US 4,237,187.
  • The scope is narrow at the chemical structure level, focusing on specific derivatives.
  • The novelty was grounded in the specific chemical modifications and their therapeutic applications.

Implications for R&D and Commercialization:

  • With patent expiry, firms can freely develop products similar to the original compound.
  • The original patent's claims do not cover new chemical derivatives post-expiry, creating room for innovation.
  • Licensing or cross-licensing agreements for existing formulations remain relevant for products still under patent protections or market exclusivity.

Conclusion

US Patent 4,868,179 covers a specific immunomodulatory compound and its use in treating immune-related diseases, with claims extending to chemical derivatives and treatment methods. The patent landscape includes similar nucleoside or phosphate analogs, with original rights expiring in 2006, allowing broader commercialization under subsequent patents or as generic alternatives.


Key Takeaways

  • The patent's scope is limited to the specified compound and its therapeutic method.
  • The patent expired in 2006, paving the way for generic development.
  • There are multiple related patents targeting similar chemical classes, requiring careful freedom-to-operate analysis.
  • The patent landscape includes derivatives and formulations from various jurisdictions, with ongoing research expanding beyond the original claims.

5 FAQs

1. What specific diseases does US 4,868,179 target?
The patent claims involve immune response modulation and are broad enough to cover viral infections, autoimmune diseases, and certain cancers.

2. Are the chemical compounds claimed in the patent still under patent protection?
No, the patent expired in 2006, allowing for generic manufacturing and further development.

3. How does related patent activity influence current development?
Similar patents on nucleoside analogs or phosphate derivatives may impose freedom-to-operate restrictions; thorough patent clearance is recommended.

4. Can a company develop new drugs based on this patent's compound?
Post-expiry, companies can develop new compounds; however, they must avoid infringing on remaining active patents for other derivatives or formulations.

5. Are there international equivalents or patent families?
Yes, filings exist in Europe, Japan, and Canada, covering similar compounds and uses, expanding the patent landscape globally.


References

[1] United States Patent and Trademark Office. (1989). US Patent 4,868,179.
[2] World Intellectual Property Organization. (n.d.). Patent family data.
[3] European Patent Office. (n.d.). Patent applications related to nucleoside derivatives.
[4] Japanese Patent Office. (n.d.). Patent filings on immunomodulatory compounds.
[5] Canadian Intellectual Property Office. (n.d.). Patent documents on similar chemical classes.

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Drugs Protected by US Patent 4,868,179

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

International Family Members for US Patent 4,868,179

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 1308659 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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