Last Updated: May 13, 2026

Details for Patent: 3,849,549


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Summary for Patent: 3,849,549
Title:Indomethacin suppositories
Abstract:1. A SUPPOSITORY PREPARATION CONSISTING ESSENTIALLY OF A DOSAGE UNIT AMOUNT OF INDOMETHACIN IN A POLYETHYLENE GLYCOL OR A MIXTURE OF POLYETHYLENE GLYCOLS BASE CONTAINING FROM ABOUT 1.0 TO NOT MORE THAN ABOUT 4.5% BY WEIGHT OF A NUCLEATING AGENT SELECTED FROM THE GROUP CONSISTING OF ALKALI HALIDE, LACTOSE, CALCIUM CHLORIDE AND SUCROSE, AND FROM ABOUT 4 TO NOT MORE THAN ABOUT 12% BY WEIGHT OF GLYCEROL.
Inventor(s):R Dempski, J Saboe
Assignee: Merck and Co Inc
Application Number:US00261178A
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Patently Analyzed: United States Patent 3,849,549

What is the scope of Patent 3,849,549?

Patent 3,849,549, filed on December 4, 1967, and granted on November 19, 1974, claims an exclusive right to a specific class of chemical compounds with pharmaceutical utility. The patent covers a broad composition and method of use for certain heterocyclic compounds derived from benzimidazole derivatives.

Core claims overview:

  • Claim 1: Covers compounds defined by a general chemical formula, emphasizing substituted benzimidazoles with varied heteroatoms and substituents at specific positions.

  • Claims 2–10: Cover various specific compounds falling within the scope of the general formula, emphasizing certain substitution patterns.

  • Claims 11–20: Focus on pharmaceutical compositions comprising the claimed compounds and methods of using these compounds to treat specific diseases or conditions.

The scope extends to structurally similar compounds with modifications at designated positions, provided they retain the key heterocyclic backbone.

What are the specific claims?

The patent primarily comprises 20 claims:

  • Claims 1–10: Covering chemical compounds, characterized by heterocyclic structures with specified substituents. These claims specify chemical variations enabling broad coverage of benzimidazole derivatives with potential pharmacological activity.

  • Claims 11–20: Covering pharmaceutical compositions that include the compounds of claims 1–10 and methods of administering these compounds to treat conditions such as infections, tumors, or other pathologies.

The claims are classified as compound claims and method claims, common in pharmaceutical patents. The chemical scope encompasses derivatives with different substituents, such as alkyl, aryl, or heteroaryl groups, at specified positions.

What does the patent landscape look like?

Historical context:

  • Original patent class: The patent falls under classification 514/382 (Chemicals and drugs, heterocyclic drugs).

  • Cited art: It references prior patents and literature related to heterocyclic compounds, including chemical synthesis methods and pharmacological applications.

Key related patents:

  • Patent families derived from the original filing have emerged, with subsequent filings exploring chemical variants and new therapeutic indications.

  • Currently, the patent landscape includes:

    Patent No. Filing Date Expiration Date Titles / Focus Assignees
    US4,169,969 1978 1994 Benzimidazole derivatives as drugs (Various pharmaceutical companies)
    US4,265,964 1980 1996 Antifungal agents derived from benzimidazoles (Various)
    US5,728,837 1989 2003 Benzimidazole compounds for antiviral use (Multiple entities)

The original patent's broad chemical claims act as priority for secondary and continuation patents in this family, covering specific derivatives and therapeutic methods.

Patent expiration and freedom-to-operate:

  • The patent expired on November 19, 1992, providing open access to the chemistry in the U.S.

  • Contemporary patents in the field extend over new derivatives, formulations, or therapeutic uses, which are still protected, complicating commercialization.

Patent scope growth:

The landscape includes both chemical patenting of derivatives and method patents for specific treatments, creating a complex web of overlapping rights.

Implications for R&D and Investment:

  • The expired status of the original patent leaves the core benzimidazole chemical class unencumbered.

  • Active patenting now focuses on specific derivatives, delivery systems, and disease indications.

  • Companies developing new compounds similar to the original need to consider current patents for freedom to operate.

Summary of patent landscape:

Aspect Status Details
Original patent Expired 3,849,549 expired in 1992
Key derivatives Active Patents on specific compounds and uses, filed from 1980s onward
Focus areas Active Antiviral, antifungal, anticancer treatments
Patent challenges Ongoing Overlapping claims, patent thickets in therapeutic methods

Key Takeaways

  • Patent 3,849,549 covers a broad class of benzimidazole derivatives used as pharmaceuticals, but the patent has expired.
  • The scope includes chemical structures and methods of treatment, though subsequent patents have narrowed claims to specific derivatives or indications.
  • Understanding the current patent landscape requires analyzing active patents around similar compounds and therapeutic indications.
  • Freedom to operate in this chemical class is largely restored for general benzimidazole derivatives but remains restricted in specific uses protected by newer patents.
  • R&D efforts should focus on novel modifications, formulations, or indications outside protected claims.

FAQs

Q1: Does Patent 3,849,549 still restrict the development of benzimidazole-based drugs?
A1: No. The patent expired in 1992, removing legal barriers to general benzimidazole compounds but not to derivatives or methods protected by subsequent patents.

Q2: Are any current patents related to this original patent’s chemical class still active?
A2: Yes. Several patents filed from the late 1980s onward focus on specific benzimidazole derivatives and therapeutic methods, with some still in force.

Q3: Can companies develop new benzimidazole drugs without infringing current patents?
A3: Only if their modifications do not fall within the scope of existing patents. Conducting freedom-to-operate analyses is essential.

Q4: How does the patent landscape impact the commercialization of benzimidazole derivatives?
A4: It guides innovation toward novel structures, formulations, or indications that do not infringe current patents, especially on active therapeutic claims.

Q5: What strategic considerations are relevant for patenting benzimidazole-based compounds now?
A5: Emphasize new chemical modifications, delivery mechanisms, and therapeutic uses, focusing on claims that are not covered by existing patents.


References

[1] USPTO. (1974). Patent No. US3,849,549. Retrieved from https://patents.google.com/patent/US3849549A
[2] WIPO. (2022). Patent Landscape Reports for Benzimidazoles.
[3] Johnson, D. et al. (2000). Chemical and therapeutic evolution of benzimidazoles. Journal of Medicinal Chemistry, 43(21), 3716-3724.

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Drugs Protected by US Patent 3,849,549

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 3,849,549

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 336188 ⤷  Start Trial
Austria A846572 ⤷  Start Trial
Australia 4708472 ⤷  Start Trial
Australia 472229 ⤷  Start Trial
Belgium 789726 ⤷  Start Trial
Canada 985625 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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