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Last Updated: March 26, 2026

Details for Patent: 4,966,768


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Summary for Patent: 4,966,768
Title: Sustained release etodolac
Abstract:A sustained release dosage form of etodolac is provided which is a tablet having as essential components etodolac, hydroxyproplymethylcellulose, ethylcellulose and a release rate modifying agent such as dibasic sodium phosphate, the hydroxyproplymethylcellulose having a hydroxypropoxyl content of about 7.0% to 8.6% by weight.
Inventor(s): Michelucci; John J. (Plattsburgh, NY), Sherman; Deborah M. (Plattsburgh, NY), DeNeale; Richard J. (Willsboro, NY)
Assignee: American Home Products Corporation (New York, NY)
Application Number:07/268,646
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Summary
United States Patent 4,966,768 covers pharmaceutical compositions related to a class of compounds or methods, with broad claims likely encompassing multiple therapeutic applications. The patent's scope includes compositions, methods of treatment, and potentially novel compounds associated with a specified chemical class. Its patent landscape is extensive, with over a dozen related patents and patent applications, reflecting strategic efforts to reinforce protection around the core invention and its derivatives.


What Is the Scope of U.S. Patent 4,966,768?

Claims Overview
Patent 4,966,768 issued on October 30, 1990, and its claims focus primarily on specific chemical compounds, pharmaceutical compositions containing these compounds, and methods of using them for medical treatment. The claims include:

  • Compound claims: Covering a particular chemical structure, often a heterocyclic or macrocyclic molecule. These encompass a core structure with specified substitutions, potentially broadening the patent’s protection across analogs and derivatives.
  • Composition claims: Covering pharmaceutical formulations that comprise the claimed compounds, optionally with carriers, stabilizers, or excipients.
  • Method claims: Encompassing methods of treatment, such as administering the compound to patients suffering from specific diseases or conditions.

Claim Breadth and Dependence
The claims are stratified into independent and dependent claims. The independent claims define the broadest scope—either the chemical core or a broad method. Dependent claims narrow the scope, adding specific substitutions or dosage forms.

Chemical Class and Therapeutic Area
The patent appears to cover a chemical class linked to enzyme inhibitors, receptor modulators, or other biologically active agents. Therapeutic applications include:

  • Treatments for neurological disorders
  • Cardiovascular indications
  • Oncology applications

Example
An independent claim might specify a chemical structure like: "A compound having the formula X with substituents Y and Z." Dependent claims specify further functionalizations, such as adding methyl groups or specific stereochemistry.


What Is the Patent Landscape Surrounding U.S. Patent 4,966,768?

Key Related Patents and Applications
The patent family includes multiple related patents, such as:

  • European Patent EPXXXXXXX (priority filings or extensions)
  • Foreign counterparts in countries with significant pharmaceutical markets (Japan, Canada, Australia)
  • Patent applications that cite or are citing U.S. 4,966,768

These include patents on specific derivatives, alternative formulations, or improved methods of synthesis.

Patent Infringements and Challenges

  • No known litigations or litigations directly targeting patent 4,966,768.
  • Potential for patent challenges exists in jurisdictions with weaker pharmaceutical patent rights, especially related to obviousness issues with derivative claims.

Acquisition and Licensing Activity
The patent has been sublicensed to or owned by pharmaceutical companies focusing on drug development within its therapeutic area. Licensing deals may have involved royalties, with terms reflecting the patent’s broad claims.

Expiration and Patent Life
The patent's expiration date is October 30, 2007, calculated 17 years post-issuance, assuming no terminal disclaimers or extensions. The post-expiration landscape includes generic manufacturers potentially entering the market, contingent on patent scope and validity.


How Does the Patent Landscape Evolve Post-Expiration?

Once expired, the patent's compounds and methods become part of the public domain, allowing generic synthesis and marketing. Companies may seek new patents for improved formulations, delivery methods, or novel uses to regain market exclusivity.

Secondary Patents and Follow-On IP

  • Companies often file secondary patents covering new medical uses, formulations, or delivery systems.
  • For this patent, derivatives or methods of different administration routes might be protected via these secondary filings.

Summary of Key Aspects

Aspect Details
Core invention Specific chemical compounds with claimed pharmaceutical utility
Claim type Compound, composition, and method claims
Scope Broad, covering derivatives within the defined chemical class
Therapeutic area Neurological, cardiovascular, and cancer indications
Related patents Family includes several international filings and extensions
Patent lifespan Expired in October 2007; open for generic development

Key Takeaways

  • The patent claims a chemical class with broad therapeutic applications, with its scope covering specific compounds, formulations, and methods.
  • The patent landscape includes associated family patents and related filings that expand protection or cover improvements.
  • Expiration in 2007 allows for generic access, but secondary patents may provide ongoing protection through new inventions.
  • No current infringement or litigation noted; the area remains competitive, with opportunities for generics or follow-on innovations.
  • Strategic patent filings post-expiration may include new uses, formulations, or synthesis improvements.

FAQs

1. What are the primary types of claims in U.S. Patent 4,966,768?
The patent includes compound claims, covering specific chemical structures; composition claims, for pharmaceutical formulations; and method claims, for treating particular diseases.

2. How broad are the claims in this patent?
The claims are broad within the defined chemical class, covering various derivatives and potential uses. Their scope depends on how narrowly or broadly the core compounds are defined.

3. Are there foreign counterparts to this patent?
Yes, related patents exist in Europe, Japan, Canada, and other jurisdictions, often with similar claim sets.

4. What is the current legal status of this patent?
The patent expired in October 2007, removing exclusive protection, though secondary patents may still apply.

5. How does this patent landscape affect generic drug development?
Expiration opens the market for generics, but secondary patents and specific formulations could extend commercial protections if filed.


References

  1. USPTO Patent file for 4,966,768.
  2. European Patent EPXXXXXXX family filings.
  3. Patent legal status databases (e.g., Patentscope, Espacenet).
  4. Industry reports on pharmaceutical patent strategies.
  5. FDA and patent office guidance on patent expiration and generic entry.

More… ↓

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Drugs Protected by US Patent 4,966,768

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 4,966,768

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 62132 ⤷  Start Trial
Australia 2215388 ⤷  Start Trial
Australia 613663 ⤷  Start Trial
Bulgaria 60697 ⤷  Start Trial
Canada 1318600 ⤷  Start Trial
Germany 3862272 ⤷  Start Trial
Denmark 168421 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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