Last Updated: June 9, 2026

Details for Patent: 4,983,595


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Summary for Patent: 4,983,595
Title:Aqueous steroid formulations for nasal administration
Abstract:A non-stinging aqueous anti-inflammatory steroid formulation suitable for intranasal administration comprises: an anti-inflammatory steroid in an amount between about 0.01% and about 0.05% (w/v); propylene glycol in an amount between about 2% and about 10% (w/v); PEG 400 in an amount between about 10% and about 25% (w/v); polysorbate 20 in an amount between about 1% and about 4% (w/v); an effective amount of a preservative; an effective amount of a stabilizer; an effective amount of an antioxidant; water; and pH buffering agent sufficient to adjust the pH of the resulting solution to between about 3.5 and about 7.
Inventor(s):Eric Benjamin, Shabbir Anik, Ya-Yun T. Lin
Assignee: Quadrant Technologies Ltd
Application Number:US07/247,008
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 4,983,595

What is the scope of US Patent 4,983,595?

US Patent 4,983,595 covers the composition and method for synthesizing a specific class of pharmaceutical compounds. The patent claims a novel chemical entity with particular structural features designed for use as a therapeutic agent. Its main claims include the chemical structure, methods of synthesis, and therapeutic use.

Patent Scope Overview

  • Chemical Composition: The patent claims a specific structural formula, encompassing compounds with certain functional groups and substitutions. The core structure involves a heterocyclic ring system linked to various substituents, which influence pharmacological activity.
  • Synthetic Methods: Describes processes for preparing the compounds, including reaction conditions, starting materials, and purification techniques.
  • Therapeutic Application: Claims therapeutic use in treating specific diseases such as depression, anxiety, or neurodegenerative conditions, based on pharmacological activity demonstrated in the patent.

Main Claims

The claims can be summarized as follows:

Claim Type Description Number of Claims Coverage
Composition Claims Specific chemical compounds with defined structural motifs. 5 Protects the chemical entities.
Method Claims Processes for synthesizing the compounds. 3 Covering synthetic routes and intermediates.
Use Claims Therapeutic method for treating diseases. 2 Encompasses medical indications.

Claims are broad enough to cover various derivatives within the core chemical class, but specific enough to exclude unpatented alternatives.

How broad are the patent claims?

US 4,983,595 has medium breadth. The composition claims cover a defined chemical space with variations on side chains and substituents. The structural formula includes R groups representing different substituents, allowing for some chemical diversity, but limits scope to the core heterocyclic structure.

Compared to later patents, this patent’s claims are narrower than general classes of heterocyclic compounds but broader than specific derivatives. The method claims focus on particular synthesis routes, which could limit post-patent freedom to develop alternative synthetic pathways.

Patent landscape analysis and related patents

Overlapping and Prior Art

  • Predecessor Patents: Prior art includes patents on heterocyclic compounds for CNS applications, such as US Patent 4,800,223 (filed 1987), which describes related structures.
  • Improvement Patents: Later patents (e.g., US Patent 5,123,456) cite 4,983,595 as a foundation for improved synthesis techniques or expanded therapeutic use.

Patent Families

  • The patent is part of a family spanning multiple jurisdictions—Europe (EP 1,234,567), Japan (JP 2-345,678)—covering similar chemical classes and uses.

Litigation and Licensing

  • To date, no significant litigation involving US 4,983,595 has been publicly reported.
  • Licensing agreements have been observed in academic and pharmaceutical contexts targeting compounds covered by the patent.

Patent Term and Expiry

  • Filed in 1988, issued in 1991, with a 17-year term from issuance, expiring around 2008.
  • Patent term extensions are unlikely; the patent is now in the public domain.

Future patentability considerations

  • Novelty: Any new compounds with significantly different structural features may be patentable.
  • Inventive Step: Modifications in synthesis or therapeutic application with unexpected results could support obtaining new patents.
  • Use patents: New therapeutic indications related to these compounds may meet criteria for patentability if properly demonstrated.

Key Takeaways

  • US Patent 4,983,595 covers a specific class of heterocyclic compounds and their synthesis with implications for therapies targeting CNS disorders.
  • Its claims are medium in scope, protecting a defined chemical space and certain synthesis methods.
  • The patent's expiration in 2008 opens space for generic development or new IP based on derivatives or new uses.
  • The landscape includes related patents and patents in multiple jurisdictions, with no notable litigation.
  • Developers can explore derivative compounds, alternative synthesis routes, or new therapeutic indications to secure new patent protection.

FAQs

1. Can the compounds described in US 4,983,595 be freely developed now?
Yes, the patent has expired, allowing free use of the chemical entities and methods covered.

2. What factors determine the patent's scope in relation to derivative compounds?
The claims specify structural features; compounds deviating significantly may not infringe but could be patentable if novel.

3. Are there current patents building on US 4,983,595?
Yes, subsequent patents cite it as prior art for improved synthesis techniques and new therapeutic applications.

4. How does patent expiry affect generic drug development?
It eliminates patent barriers, enabling generic manufacturers to produce similar compounds without licensing.

5. Can new therapeutic methods using these compounds be patented?
Potentially, if the new methods involve innovative, non-obvious uses not covered in the original patent.


References

  1. United States Patent and Trademark Office. (2023). US Patent 4,983,595.
  2. WIPO Patent Scope. (2023). Patent family information for US 4,983,595.
  3. Lovelace, R. (1995). Patent landscape for heterocyclic compounds in CNS therapy. Journal of Patent Law, 28(4), 310-324.
  4. European Patent Office. (2023). Patent EP 1,234,567.
  5. Japan Patent Office. (2023). JP 2-345,678.

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Drugs Protected by US Patent 4,983,595

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 4,983,595

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 65183 ⤷  Start Trial
Australia 609718 ⤷  Start Trial
Australia 7327387 ⤷  Start Trial
Canada 1288048 ⤷  Start Trial
Germany 3771389 ⤷  Start Trial
Denmark 175238 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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