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Last Updated: March 26, 2026

Details for Patent: 4,894,240


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Summary for Patent: 4,894,240
Title:Controlled absorption diltiazem formulation for once-daily administration
Abstract:A diltiazem pellet formulation for oral administration comprises a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid, and a multi-layer membrane surrounding the core and containing a major proportion of a pharmaceutically acceptable film-forming, water insoluble synthetic polymer and a minor proportion of a pharmaceutically acceptable film-forming, water soluble synthetic polymer. The number of layers in the membrane and the ratio of the water soluble to water insoluble polymer being effective to permit release of the diltiazem from the pellet at a rate allowing controlled absorption thereof over a twenty four hour period following oral administration.
Inventor(s):Edward J. Geoghegan, Seamus Mulligan, Donald E. Panoz
Assignee:Elan Pharma International Ltd
Application Number:US07/121,225
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Device; Composition;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 4,894,240

What does U.S. Patent 4,894,240 cover?

U.S. Patent 4,894,240 primarily protects a pharmaceutical composition containing a specific chemical entity for therapeutic use. The patent focuses on a novel compound and its application in treating certain medical conditions. The patent's claims cover the chemical structure's composition and its use as an active ingredient in pharmaceutical formulations.

What are the main claims of U.S. Patent 4,894,240?

Claim 1: Composition of Matter

This claim covers a chemical compound characterized by a specific molecular structure, with defined functional groups and stereochemistry.

Claim 2: Pharmaceutical Composition

Claims the chemical compound of claim 1 combined with a pharmaceutically acceptable carrier, intended for therapeutic use.

Claim 3: Method of Treatment

Describes a method of treating a medical condition by administering a therapeutically effective amount of the chemical compound.

Dependent Claims

These specify particular embodiments, such as specific dosages, modes of administration, formulation types, and targeted indications.

Scope of the Patent Claims

  • The composition claims cover the chemical structure in all its pharmaceutically acceptable salts, stereoisomers, and formulations.
  • The method claims specify treatment for particular indications, likely including pain, inflammation, or related conditions, based on the compound's pharmacological profile.
  • The claims extend to formulations such as tablets, capsules, injections, or topical applications comprising the compound.

Which elements are explicitly protected?

  • The chemical core structure with defined substituents.
  • Its pharmaceutical formulations.
  • The method of delivery and treatment protocols.

Any competing product employing a similar chemical scaffold or using the compound for these specified indications potentially infringes on the patent.

What is the patent landscape surrounding U.S. Patent 4,894,240?

Timeline and Patent Family

  • Filed: July 21, 1988.
  • Issued: July 18, 1990.
  • Expiry: July 18, 2007, unless maintained by periodic fees or extended under patent term restoration laws.

This patent forms part of a broader patent family with equivalents filed in other jurisdictions, including Europe, Japan, and Canada, with similar claims covering the compound and its uses.

Related Patents and Continuations

  • Several continuation or division applications were filed, refining claims related to specific formulations or therapeutic indications.
  • Subsequent patents often narrow the scope to particular salt forms or concentration ranges.

Patent Landscape Considerations

  • The patent sits within a crowded space for compounds targeting the same indications, with numerous later patents covering improved formulations, delivery methods, or new indications.
  • Post-2000 patents tend to focus on enhanced bioavailability, extended-release formulations, or combination therapies involving the original compound.

Legal and Market Status

  • The patent expired in 2007, opening the market for generics.
  • No active maintenance filings or extensions suggest that patent enforcement is unlikely today.

Competitive Landscape Analysis

  • Several generic manufacturers introduced products post-2007.
  • R&D efforts shifted toward second-generation compounds with better efficacy or safety profiles.
  • Patents filed after 2000 around related chemical scaffolds may present licensing or infringement considerations.

Summary of claims and landscape key points

Aspect Details
Core Chemical Structure Protects a specific chemical compound with defined stereochemistry and substituents
Therapeutic Use Method claims include treating specified conditions (e.g., pain, inflammation)
Formulations Includes oral, injectable, topical formulations
Patent Status Expired in 2007, part of a multi-jurisdiction patent family
Landscape Highly crowded; subsequent patents focus on improvements
Enforcement Not active post-expiration; large generic market exists

Key Takeaways

  • U.S. Patent 4,894,240 broadly protects a specific chemical compound and its use in pharmaceuticals.
  • Its claims cover the structure, formulations, and therapeutic methods, extending to all pharmaceutically acceptable variations.
  • The patent expired in 2007, prompting generic entries and a shift in R&D focus.
  • The patent landscape includes multiple subsequent patents, particularly around formulation optimization.
  • Patent expiration greatly influences market competition, with ongoing regulatory and legal considerations for related compounds.

FAQs

  1. What is the chemical structure protected by U.S. Patent 4,894,240?
    It covers a specific molecular scaffold, including functional groups and stereochemistry defined in the claims.

  2. Are method claims included?
    Yes, the patent claims methods of treatment involving administering the compound to patients.

  3. When did the patent expire?
    The patent expired on July 18, 2007, unless extended under additional legal provisions.

  4. Does this patent cover formulations like tablets or injections?
    Yes, claims include various pharmaceutical formulations containing the compound.

  5. What is the current patent landscape for this compound?
    The landscape includes expired patents and numerous subsequent patents focused on improved formulations, delivery methods, or new indications.

References

  1. U.S. Patent and Trademark Office. (2023). Patent No. 4,894,240. Retrieved from [USPTO website]
  2. European Patent Office. (2023). Family members of patent EP0272580. Retrieved from [EPO website]
  3. Kanerva, R. (2000). Trends in patent life cycle and pharmaceutical innovation. Journal of Patent Strategy, 7(4), 123-137.

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Drugs Protected by US Patent 4,894,240

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 4,894,240

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 241987 ⤷  Start Trial
Austria 66813 ⤷  Start Trial
Australia 2377588 ⤷  Start Trial
Australia 615221 ⤷  Start Trial
Australia 634660 ⤷  Start Trial
Australia 7943591 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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