Last Updated: May 10, 2026

CARBENICILLIN DISODIUM - Generic Drug Details


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What are the generic sources for carbenicillin disodium and what is the scope of patent protection?

Carbenicillin disodium is the generic ingredient in two branded drugs marketed by Roerig and Glaxosmithkline, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for CARBENICILLIN DISODIUM
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 53
Clinical Trials: 1
DailyMed Link:CARBENICILLIN DISODIUM at DailyMed
Recent Clinical Trials for CARBENICILLIN DISODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all CARBENICILLIN DISODIUM clinical trials

US Patents and Regulatory Information for CARBENICILLIN DISODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roerig GEOPEN carbenicillin disodium INJECTABLE;INJECTION 050306-007 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Roerig GEOPEN carbenicillin disodium INJECTABLE;INJECTION 050306-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline PYOPEN carbenicillin disodium INJECTABLE;INJECTION 050298-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Roerig GEOPEN carbenicillin disodium INJECTABLE;INJECTION 050306-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline PYOPEN carbenicillin disodium INJECTABLE;INJECTION 050298-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline PYOPEN carbenicillin disodium INJECTABLE;INJECTION 050298-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CARBENICILLIN DISODIUM Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Carbenicillin Disodium?

Carbenicillin disodium is a broad-spectrum penicillin antibiotic used mainly for susceptible bacterial infections, notably urinary tract infections, pneumonia, and bacteremia. Its market presence fluctuates due to several factors:

  • Market Size: The global beta-lactam antibiotic market, which includes carbenicillin disodium, is valued at approximately $15 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 3-4% through 2030 (source: Grand View Research[1]).

  • Demand Drivers: Growing bacterial resistance to existing antibiotics compels the need for broader-spectrum agents. However, the clinical use of carbenicillin disodium has declined due to observed resistance and the advent of newer antibiotics.

  • Regulatory Environment: The drug's approval status varies by region. In the United States, it is not commercially available under the FDA, whereas in some countries like India and China, it remains prescribed and supplied. Regulatory barriers or discontinuation also influence market availability globally.

  • Competitive Landscape: The market is saturated with alternatives such as piperacillin-tazobactam and ampicillin-based therapies, reducing its market share.

  • Clinical Trends: The shift toward combination therapies and newer antibiotics reduces the utilization of older agents like carbenicillin disodium.

  • Manufacturers: Eisai Co. and other generic producers have historically supplied the drug, but manufacturing has declined in recent years, driven by low demand.

How Is the Financial Trajectory Shaped for Carbenicillin Disodium?

The financial outlook for carbenicillin disodium is characterized by declining revenues and limited future growth prospects:

Aspect Details
Historical Revenue (US) Limited; no significant recent sales due to non-approval by FDA and market decline.
Market Share Perceived as limited; mostly niche, regional use rather than global.
Revenue Trends Declining over the last decade, mainly due to decreased demand and competition.
Investment in R&D Minimal or discontinued, reflecting reduced market interest.
Pricing Remains low, generally aligned with generics; no premium for innovation.

Revenue estimates suggest negligible or declining sales in key markets like North America, with some regional markets maintaining limited use due to local regulatory approval. The absence of FDA approval in the US effectively seals off the large North American market, constraining growth.

Investment outlook indicates minimal R&D activity surrounding the drug, with pharmaceutical companies shifting focus toward new beta-lactams and other classes with higher efficacy or better resistance profiles. Historical data from Lexicomp and Micromedex suggests the drug is rarely prescribed in North America, with overseas markets serving as the only consumption zones.

How Do Patent Statuses and Regulatory Changes Impact Market and Financial Outlook?

  • Patent Status: Carbenicillin disodium has been off-patent globally for decades, with no recent patent filings. The absence of patent protections limits pricing power and investment incentives.

  • Regulatory Changes: New antimicrobial stewardship guidelines and regulatory restrictions, especially in North America and Europe, diminish the drug’s utilization. The combination of limited approvals, especially in major markets, constrains revenue flow.

What Are Future Trends and Potential Growth Opportunities?

  • The drug's future hinges on regional demand, particularly in markets lacking newer antibiotics or where local manufacturing persists.

  • As antibiotic resistance rises in specific regions, there could be potential for re-evaluation if resistance to current treatments becomes severe. Still, no recent clinical trials or development initiatives focus on carbenicillin disodium.

  • The growth of personalized medicine and targeted therapies does not favor broad-spectrum antibiotics like carbenicillin disodium.

Key Takeaways

  • The global market for carbenicillin disodium is small and contracting, driven by resistance, competition, and regulatory limitations.

  • The drug's revenue is declining, with limited prospects for recovery due to off-patent status and reduced clinical use.

  • Market growth remains modest, with regional variations affecting supply and demand.

  • No active R&D initiatives or regulatory approvals anticipate future expansion.

  • Companies should monitor regional antimicrobial resistance patterns, but current forecasts suggest minimal commercial significance.

FAQs

1. Why is carbenicillin disodium largely obsolete in the US?
It lacks FDA approval and has been replaced by newer, more effective antibiotics with broader spectrums and better safety profiles.

2. Are there any ongoing clinical trials involving carbenicillin disodium?
No public records indicate current clinical trials or development activities.

3. Can regional markets expand for this drug?
Potentially in regions with limited access to newer antibiotics, but overall demand is low and declining.

4. How does resistance affect the use of carbenicillin disodium?
Bacterial resistance reduces efficacy, leading clinicians to prefer alternative antibiotics, further shrinking the market.

5. What is the outlook for generic manufacturers?
Limited prospects; declining demand reduces incentive to produce, and oversupply risks depress pricing.

References

[1] Grand View Research, "Beta-Lactam Antibiotics Market Size & Share," 2023.

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