Last Updated: May 2, 2026

cinoxacin - Profile


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What are the generic drug sources for cinoxacin and what is the scope of patent protection?

Cinoxacin is the generic ingredient in two branded drugs marketed by Lilly and Teva, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Summary for cinoxacin
US Patents:0
Tradenames:2
Applicants:2
NDAs:3

US Patents and Regulatory Information for cinoxacin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly CINOBAC cinoxacin CAPSULE;ORAL 018067-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly CINOBAC cinoxacin CAPSULE;ORAL 018067-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Teva CINOXACIN cinoxacin CAPSULE;ORAL 073005-001 Feb 28, 1992 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Teva CINOXACIN cinoxacin CAPSULE;ORAL 073006-001 Feb 28, 1992 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

Cinoxacin Market Analysis and Financial Projection

Last updated: February 13, 2026

What Is the Current Investment Outlook for Cinoxacin?

Cinoxacin, a fluoroquinolone antibiotic, has declined in market prominence due to emerging resistance and competition from newer agents. Its limited current sales and lack of recent approval activity raise concerns about its growth potential. Upside possibilities are limited unless repositioned or reformulated for niche indications.

What Are the Market Fundamentals for Cinoxacin?

Market Size and Usage Trends

  • Historical Use: Previously indicated for urinary tract infections (UTIs).
  • Current Status: Outdated by newer fluoroquinolones with broader spectral activity and better safety profiles.
  • Market Size: Small; estimated global annual sales are under $10 million, primarily in some Asian markets.
  • Growth Drivers: None significant; declining due to resistance issues and safety concerns emerging in fluoroquinolone class.

Competitive Landscape

Competitors Key Features Market Share Regulatory Status
Ciprofloxacin Broad spectrum, extensive approval Majority of fluoroquinolone sales Widely approved, numerous formulations
Levofloxacin Once-daily dosing, high efficacy Significant in UTI and respiratory infections Approved globally
Ofloxacin Similar to ciprofloxacin, less potent Moderate use Approved, but usage declining
Cinoxacin Narrow spectrum, older drug Marginal, mostly in specific markets Limited approval, market exit in many regions

Regulatory and Patent Status

  • FDA & EMA: No recent approvals for cinoxacin; standard withdrawals in many countries.
  • Patent Landscape: Patent expiration in early 2000s; no new patents filed, reducing market exclusivity and licensing appeal.

R&D and Investment Viability

  • No current pipeline activity or reformulation efforts.
  • Limited scope for orphan or niche indications without significant reformulation or repurposing.
  • Risks include resistance development, safety issues, and competitive obsolescence.

What Are the Investment Risks and Opportunities?

Risks

  • Market decline due to safety concerns and resistance.
  • Limited patent protection, leading to generic erosion.
  • Regulatory hurdles for market re-entry or new indications.

Opportunities

  • Potential niche use in organisms resistant to newer antibiotics.
  • Reformulation for topical or localized delivery to bypass systemic safety issues.
  • Use as a base compound for novel antibiotics, though no active development reported.

What Are the Key Considerations for Stakeholders?

  • Commercial viability remains low without a clear niche or reformulation.
  • Repositioning or reformulation efforts could create limited opportunities, but require substantial investment.
  • Market exit may be advisable given current dynamics unless a disruptive strategy emerges.

What Is the Overall Investment Recommendation?

Based on current market data, negligible sales, environmental resistance, and regulatory challenges, direct investment in cinoxacin presents minimal near-term value. Investors should monitor for rebranding, reformulation, or niche repositioning, noting the high risk profile.

Summary Table: Investment Fundamentals for Cinoxacin

Factor Assessment Implication
Market Size Under $10 million globally Small and shrinking
Competitive Position Outdated, limited efficacy Low market share
Patent & Regulatory Status Expired patents, minimal approvals No protection or incentives
R&D Activity None reported No upcoming pipeline
Resistance & Safety Growing concerns Market exit risk

Key Takeaways

  • Cinoxacin's market is small, declining, and lacks recent approval activity.
  • The competitive advantage of cinoxacin diminishes with newer fluoroquinolones.
  • Patent expiry and safety issues restrict potential for revival.
  • Niche opportunities require considerable investment and reformulation.
  • Moderate to high risk presence undervalues current investment prospects.

FAQs

1. Is there a current therapeutic advantage in using cinoxacin over newer fluoroquinolones?
No; newer agents typically offer broader spectrum, improved safety, and dosing convenience.

2. Are there ongoing research efforts to reintroduce cinoxacin?
No significant research activities are publicly documented.

3. Could cinoxacin be repurposed for other indications?
Potentially, but no current development initiatives exist; re-targeting would demand substantial R&D.

4. What regulatory barriers would affect cinoxacin’s market re-entry?
Regulatory agencies require safety and efficacy data comparable to current standards, which cinoxacin lacks.

5. Is there any geographic market where cinoxacin remains relevant?
Limited use persists in select Asian markets, but overall market size remains minimal.


Sources:

[1] Drugs.com. Cinoxacin drug profile.
[2] EvaluatePharma. Market analysis on fluoroquinolones.
[3] USFDA drug approvals database.
[4] PatentScope. Patent expiration details for cinoxacin.

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