Last Updated: May 3, 2026

loracarbef - Profile


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What are the generic sources for loracarbef and what is the scope of freedom to operate?

Loracarbef is the generic ingredient in one branded drug marketed by King Pharms and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for loracarbef
US Patents:0
Tradenames:1
Applicants:1
NDAs:2

US Patents and Regulatory Information for loracarbef

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
King Pharms LORABID loracarbef CAPSULE;ORAL 050668-001 Dec 31, 1991 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
King Pharms LORABID loracarbef CAPSULE;ORAL 050668-002 Apr 5, 1996 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
King Pharms LORABID loracarbef FOR SUSPENSION;ORAL 050667-001 Dec 31, 1991 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
King Pharms LORABID loracarbef FOR SUSPENSION;ORAL 050667-002 Dec 31, 1991 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

Investment Scenario and Fundamentals Analysis: Loracarbef

Last updated: February 28, 2026

What is Loracarbef?

Loracarbef is a second-generation cephalosporin antibiotic marketed primarily for the treatment of bacterial infections such as respiratory tract infections, urinary tract infections, and skin infections. It is a broad-spectrum, beta-lactam antibiotic, administered orally. Loracarbef's chemical structure resembles cefaclor, with increased stability against certain beta-lactamases.

Market Overview and Commercial Status

Loracarbef received FDA approval in 1987 but was withdrawn from the U.S. market in 2003 due to declining sales and the availability of generics with improved formulations. Worldwide, the drug remains marketed in several countries, primarily through generic manufacturers.

Global antibiotic sales generate approximately $45 billion annually (IQVIA, 2022). Market dynamics are increasingly influenced by antibiotic resistance concerns, regulatory restrictions, and antibiotic stewardship initiatives, impacting both existing products and potential new entrants.

Competitive Landscape

The antibiotic market is highly competitive, with major players like Pfizer, GlaxoSmithKline, and small generic firms. Loracarbef faces competition from:

  • Other oral cephalosporins: cefuroxime axetil, cefdinir, cefpodoxime
  • Generic formulations: wide availability reduces pricing power
  • Escalating resistance issues: diminishing efficacy of older drugs

Key competitive factors include:

Factor Impact on Loracarbef
Efficacy Similar to counterparts; limited differentiation
Resistance Growing resistance diminishes use
Formulation Generic markets dominate; limited innovation potential
Patent Status Launched before patent protections expired; likely no current exclusivity

R&D and Regulatory Perspective

Since market withdrawal in some regions, no major R&D efforts target loracarbef specifically. The core issue centers on antibiotics' development risks and regulatory challenges. The global push for new antibiotics faces barriers including:

  • High development costs
  • Short product life cycles due to resistance
  • Stringent regulatory pathways

No recent clinical trials or approvals for loracarbef suggest low current investment interest.

Investment Fundamentals

Revenue potential

Limited, given market decline and generic prevalence. No recent sales data available; historical sales (pre-2003) were modest.

Cost considerations

Minimal development costs are involved in manufacturing generics. R&D investment is negligible or absent.

Patent and exclusivity

Expired decades ago; no patent protection remains. Market access depends on manufacturing capacity and regulatory compliance.

Market risks

  • Resistance development reduces efficacy and adoption
  • Regulatory changes in antibiotic stewardship restrict usage
  • Competition from newer antibiotics with broader spectra and improved safety

Growth prospects

Limited unless repositioned as part of combination therapies or for niche indications. Current market conditions do not favor significant growth.

Strategic Outlook

For investors considering loracarbef:

  • It presents no significant growth opportunity as a standalone product
  • Market decline and resistance reduce potential for profitability
  • Opportunities exist primarily in niche or off-label uses, which are unlikely to provide sustainable revenue streams

Investments should prioritize novel antibiotics under development or stakeholders involved in antibiotic stewardship solutions.

Key Takeaways

  • Loracarbef's original market has declined; it is mainly available as a generic.
  • Resistance and regulatory pressures constrain its future growth.
  • No recent development or regulatory activity signifies limited innovation prospects.
  • Market dynamics favor newer antibiotics with improved profiles.
  • Investment risks outweigh potential rewards given current market realities.

FAQs

1. Is loracarbef still marketed globally?
Yes, mainly through generic manufacturers in select countries; however, its market presence is limited.

2. Would investing in loracarbef be profitable?
Unlikely, due to declining sales, resistance issues, and large generic competition.

3. Are there any ongoing clinical trials involving loracarbef?
No recent clinical trials are publicly documented.

4. Could loracarbef be repurposed for new indications?
Given its age and competition, repurposing prospects are limited unless supported by significant evidence and regulatory approval.

5. What are the main challenges facing older antibiotics like loracarbef?
Increasing resistance, regulatory restrictions, and market saturation reduce profitability potential.

References

  1. IQVIA. (2022). The Global Use of Medicines. IQVIA Institute.
  2. U.S. Food and Drug Administration. (2003). Market withdrawal notices for cephalosporins.
  3. World Health Organization. (2021). Antimicrobial Resistance Global Report.

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