AZLOCILLIN SODIUM - Generic Drug Details

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

Azlocillin sodium is the generic ingredient in one branded drug marketed by Bayer Pharms and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Summary for AZLOCILLIN SODIUM

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	60
DailyMed Link:	AZLOCILLIN SODIUM at DailyMed

Medical Subject Heading (MeSH) Categories for AZLOCILLIN SODIUM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for AZLOCILLIN SODIUM

J01CA	Penicillins with extended spectrum
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for AZLOCILLIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Pharms	AZLIN	azlocillin sodium	INJECTABLE;INJECTION	062417-003	Oct 12, 1982		DISCN	No	No
Bayer Pharms	AZLIN	azlocillin sodium	INJECTABLE;INJECTION	062388-001	Sep 8, 1982		DISCN	No	No
Bayer Pharms	AZLIN	azlocillin sodium	INJECTABLE;INJECTION	050562-003	Sep 3, 1982		DISCN	No	No
Bayer Pharms	AZLIN	azlocillin sodium	INJECTABLE;INJECTION	062388-002	Sep 8, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Azlocillin Sodium

Last updated: February 15, 2026

Azlocillin sodium, an extended-spectrum penicillin antibiotic, targets bacterial infections, particularly those resistant to other antibiotics. It is primarily used in hospital settings for serious infections caused by gram-negative bacteria, including Pseudomonas aeruginosa.

Market Landscape

1. Current Approval and Usage: Azlocillin sodium remains approved in select countries such as Russia, China, and some Eastern European markets. It is not approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Its limited regional approval constrains export and sales potential.

2. Market Size and Segmentation: The global antibiotic market was valued at approximately USD 50 billion in 2022. Penicillin derivatives constitute a small segment, with pipeline drugs and newer treatments increasingly displacing older antibiotics. Azlocillin's specific niche—hospital treatment of multidrug-resistant infections—keeps its sales limited to niche hospital markets.

3. Competitive Position:

   • Prescribed antibiotics such as piperacillin-tazobactam, ceftazidime, and meropenem dominate the hospital environment.
   • Azlocillin faces competition from these newer, often more convenient or broader-spectrum agents.
   • Resistance profiles also impact prescription choices; resistance to penicillin-class antibiotics has been increasing, limiting azlocillin’s utility.

4. Regulatory and Patent Environment:

   • Limited patent protection outside of certain jurisdictions.
   • Absence of regulatory approval in major markets like the U.S. and EU restricts commercialization.
   • No recent patent filings suggest low likelihood of exclusivity into the foreseeable future.

Market Drivers

1. Rising Antibiotic Resistance: The increase in multidrug-resistant bacteria sustains interest in older antibiotics, including azlocillin, especially where newer drugs are ineffective.

2. Hospital Antibiotic Use: Azlocillin's use is confined largely to hospital settings, where serious infections require injectable antibiotics. The growth of such hospital-acquired infections sustains demand.

3. Regional Demand: Countries with restricted access to newer antibiotics, such as some Asian, African, and Eastern European nations, prefer established agents like azlocillin, boosting regional sales.

Market Constraints

1. Limited Efficacy Data: Lack of extensive clinical trials limits its global acceptance.

2. Safety and Resistance Concerns: Rising resistance reduces effectiveness, and safety profiles in comparison to newer agents may hinder adoption.

3. Manufacturing and Supply: Suppliers primarily produce for regional markets, restricting supply chain expansion.

Financial Trajectory

• Historical Revenue: Precise sales data is unavailable. Anecdotal reports indicate modest revenues, primarily from regional markets with approvals.

• Projected Growth:

  • Stable in niche markets: Demand remains steady in approved regions, estimated at USD 10-20 million annually.
  • Limited growth potential: Without major regulatory approval or new formulations, expansion is unlikely.
  • Potential uptick: Driven by rising resistance, estimated incremental revenue of 2-5% annually if resistance pressures increase and usage remains stable.

• Investment & R&D Outlook:

  • No recent significant R&D investment reported.
  • Pharmaceutical companies focus more on broad-spectrum or novel agents, reducing interest in repurposing older antibiotics like azlocillin.

Strategic Implications

• Companies with rights in approved jurisdictions may optimize revenues through regional marketing.
• Entry into new markets requires overcoming regulatory hurdles and demonstrating efficacy and safety.
• Future growth hinges on niche clinical needs and regional demand, with little indication of large-scale expansion.

Key Takeaways

• Azlocillin sodium's restricted regional approval limits its market reach.
• It competes mainly with newer broad-spectrum antibiotics; resistance reduces its efficacy.
• Small but stable niche demand exists mainly in hospital settings within approved regions.
• Without regulatory approval and competitive differentiation, the financial trajectory suggests limited growth prospects.
• Rising bacterial resistance maintains some clinical niche, but broader adoption remains unlikely.

FAQs

1. What is azlocillin sodium primarily used for? It treats serious bacterial infections caused by gram-negative bacteria, particularly in hospital settings.

2. Why is azlocillin sodium not widely available? It lacks regulatory approval in major markets like the U.S. and EU and faces competition from newer antibiotics.

3. What impacts azlocillin's sales potential? Regulatory restrictions, increasing bacterial resistance, competition, and limited clinical data.

4. Can azlocillin sodium become a blockbuster drug? Unlikely, given its restricted use, competition, and absence of significant R&D efforts.

5. Is there potential for growth in regional markets? Yes, in approved regions with high resistance levels and limited access to newer antibiotics, but overall growth remains modest.

Sources

[1] MarketResearch.com, "Global Antibiotic Market," 2023.
[2] FDA and EMA approval databases, 2023.
[3] Evaluations of bacterial resistance trends, CDC and WHO reports, 2022.
[4] Industry reports on regional antibiotic usage, 2022-2023.