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Last Updated: December 18, 2025

PENICILLIN G PROCAINE - Generic Drug Details


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What are the generic sources for penicillin g procaine and what is the scope of patent protection?

Penicillin g procaine is the generic ingredient in three branded drugs marketed by Lilly, Consolidated Pharm, King Pharms Llc, Parke Davis, and Pfizer, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for penicillin g procaine.

Summary for PENICILLIN G PROCAINE
US Patents:0
Tradenames:3
Applicants:5
NDAs:6
Drug Master File Entries: 10
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 4
Drug Prices: Drug price trends for PENICILLIN G PROCAINE
What excipients (inactive ingredients) are in PENICILLIN G PROCAINE?PENICILLIN G PROCAINE excipients list
DailyMed Link:PENICILLIN G PROCAINE at DailyMed
Drug Prices for PENICILLIN G PROCAINE

See drug prices for PENICILLIN G PROCAINE

Recent Clinical Trials for PENICILLIN G PROCAINE

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

SponsorPhase
Alphacait, LLCPhase 2
Haining Health-Coming Biotech Co., Ltd.Phase 2
Save the ChildrenPhase 3

See all PENICILLIN G PROCAINE clinical trials

Medical Subject Heading (MeSH) Categories for PENICILLIN G PROCAINE

US Patents and Regulatory Information for PENICILLIN G PROCAINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer PFIZERPEN-AS penicillin g procaine INJECTABLE;INJECTION 060286-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Consolidated Pharm PENICILLIN G PROCAINE penicillin g procaine INJECTABLE;INJECTION 060800-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
King Pharms Llc PENICILLIN G PROCAINE penicillin g procaine INJECTABLE;INJECTION 060101-002 Approved Prior to Jan 1, 1982 RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer PFIZERPEN-AS penicillin g procaine INJECTABLE;INJECTION 060286-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Parke Davis PENICILLIN G PROCAINE penicillin g procaine INJECTABLE;INJECTION 062029-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Consolidated Pharm PENICILLIN G PROCAINE penicillin g procaine INJECTABLE;INJECTION 060800-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Penicillin G Procaine

Last updated: July 29, 2025

Introduction

Penicillin G Procaine remains a cornerstone antibiotic in clinical practice, particularly in the treatment of syphilis, various bacterial infections, and as an adjunct in certain surgical procedures. While its dominance in antimicrobial therapy has persisted for decades, the evolving landscape of pharmaceuticals, driven by antibiotic resistance and emerging therapies, shapes its current market dynamics and future financial trajectory.

Overview of Penicillin G Procaine

Penicillin G Procaine is a long-acting injectable penicillin derivative derived from the penicillin family of antibiotics. It combines crystalline Penicillin G with Procaine, a local anesthetic that enhances absorption and prolongs the drug's action. Its pharmacokinetic profile allows for sustained antibacterial activity, making it advantageous for specific clinical indications, especially in the treatment of syphilis and bacterial endocarditis [[1]].

Although synthetic and generic versions dominate, Penicillin G Procaine’s patent exclusivity has long expired, resulting in a largely commoditized market with several manufacturers worldwide.

Market Dynamics

Global Demand and Usage Trends

The demand for Penicillin G Procaine remains relatively stable, driven predominantly by infectious disease burdens in developing regions and specific clinical applications in developed nations. The World Health Organization (WHO) underscores syphilis management as a key driver, with Penicillin G Procaine being first-line therapy [[2]].

However, the global antibiotic market has experienced disruptions owing to rising antimicrobial resistance, which limits the efficacy of traditional penicillins against resistant strains. Consequently, there is increased scrutiny over proper usage, leading to regulatory constraints and stewardship programs that impact overall consumption.

In developed markets, declining incidence rates of syphilis and improved disease management have led to stabilized or marginally declining sales. Conversely, in low-to-middle-income countries (LMICs), where infectious diseases are more prevalent yet resource constraints limit access to newer antibiotics, Penicillin G Procaine continues to be vital.

Market Segmentation and Geographic Distribution

  • Developed Markets: The United States, Europe, and Japan primarily utilize Penicillin G Procaine for syphilis, rheumatic fever prophylaxis, and certain bacterial infections. Here, the market is characterized by mature demand, with a shift towards more resistant-infection treatments.

  • Emerging Markets: Countries in Africa, Southeast Asia, and Latin America exhibit higher demand linked to tuberculosis, syphilis, and bacterial infections. Regulatory environments in these markets facilitate continued use and production, often relying on imported and locally produced generics.

Competitive Landscape

Major pharmaceutical companies and generic producers manufacture Penicillin G Procaine, leading to a highly competitive pricing environment. No patent restrictions exist, facilitating low-cost production. However, quality control remains paramount to prevent substandard or counterfeit products, which is an ongoing concern impacting brand reputation and market shares.

Regulatory and Supply Chain Considerations

Regulatory bodies, including the FDA and EMA, enforce strict standards on injectable antibiotics, impacting manufacturing processes and market entry barriers. Supply chain disruptions—exacerbated during the COVID-19 pandemic—have highlighted vulnerabilities, especially in sourcing raw materials like phenoxymethylpenicillin and Procaine.

Furthermore, the global push towards antimicrobial stewardship influences prescribing patterns, with regulatory agencies advocating for prudent use to avoid fostering drug resistance.

Financial Trajectory

Revenue Projections

Given the persistent necessity of Penicillin G Procaine, especially in regions with high infectious disease burdens, the drug’s market revenue is expected to be relatively stable in the near term. However, the CAGR (compound annual growth rate) is projected to be modest—around 1-2% globally—due to market saturation in high-income countries and sustained demand in emerging markets [[3]].

Pricing Trends

Pricing in developed nations is influenced by reimbursement policies, healthcare system budgets, and generic competition, contributing to downward pressure. Conversely, in LMICs, pricing remains affordable by design but may vary due to regulatory standards and procurement practices.

Impact of Antimicrobial Resistance and Innovation

The advent of resistant bacteria strains limits Penicillin G Procaine's utility. Resistance to penicillin-class antibiotics has been documented, especially in pneumococcal and streptococcal infections, prompting clinicians to shift towards broad-spectrum alternatives [[4]].

Innovations like combination therapies and novel formulations, while not directly impacting Penicillin G Procaine sales, influence the overall antimicrobial market landscape.

Emerging Opportunities and Risks

  • Opportunities:

    • Increasing global health initiatives targeting syphilis and bacterial infections.
    • Expansion in supply chains within LMICs.
    • Development of improved formulations with enhanced stability and administration.
  • Risks:

    • Rising antibiotic resistance diminishing therapeutic efficacy.
    • Regulatory restrictions limiting use.
    • Competition from newer antimicrobial classes.

Market Outlook

While Penicillin G Procaine remains indispensable, its market is gradually transitioning from growth phase to stability. The emphasis on antimicrobial stewardship and resistance challenges may result in slight declines in developed nations but continue to support demand in underserved regions. A diversified portfolio approach, integrating stewardship-driven prescribing and innovative formulations, will be crucial for sustaining market relevance.

Key Drivers and Barriers

Drivers:

  • Enduring necessity for syphilis treatment.
  • Cost-effective manufacturing and globally established supply chains.
  • Public health initiatives targeting infectious diseases.

Barriers:

  • Antibiotic resistance reducing clinical efficacy.
  • Regulatory hurdles and procurement complexities.
  • Competition from alternative antibiotics and advanced therapies.

Conclusion

The financial trajectory of Penicillin G Procaine is characterized by stability amid modest growth, heavily influenced by regional epidemiology, resistance patterns, and healthcare policies. Its long-standing clinical utility and widespread production underpin a resilient market, but future viability hinges on addressing resistance issues and adapting to evolving regulatory landscapes.


Key Takeaways

  • Penicillin G Procaine remains essential for specific infections like syphilis, with steady global demand, especially in developing regions.
  • Market growth is slow, averaging around 1-2% annually, constrained by resistance, regulatory policies, and changing clinical practices.
  • Generic manufacturing dominates, leading to competitive pricing; quality control remains a critical focus.
  • Rising antimicrobial resistance and stewardship initiatives pose both challenges and opportunities for reformulation and optimized use.
  • Innovations in formulations and supply chains, coupled with increased disease burden management, will be key to sustaining its market presence.

FAQs

1. How does antimicrobial resistance affect the market for Penicillin G Procaine?
Resistance diminishes the drug’s efficacy against certain bacteria, prompting clinicians to shift toward alternative treatments, which can reduce overall demand and limit market growth.

2. Are there new formulations of Penicillin G Procaine in development?
While current developments focus on improving stability and administration (e.g., copious volume formulations), no major novel formulations have disrupted the market recently.

3. What are the major geographic markets for Penicillin G Procaine?
Developed markets like the U.S. and Europe exhibit stabilized demand, whereas LMICs experience sustained or growing demand driven by infectious disease prevalence.

4. How are regulatory policies impacting Penicillin G Procaine’s availability?
Stringent quality standards ensure drug safety but can elevate manufacturing costs and create barriers for new entrants, maintaining quality but potentially limiting supply.

5. What is the future outlook for Penicillin G Procaine in global healthcare?
Its role is expected to remain significant in regions where infectious diseases are prevalent, but global trends toward resistance management may require strategic adaptation to preserve its utility.


References

[1] World Health Organization. "Global Health Sector Strategies on Sexually Transmitted Infections, 2016–2021." WHO, 2016.
[2] Centers for Disease Control and Prevention. "Syphilis—Revised Guidelines." CDC, 2015.
[3] MarketResearch.com. "Global Antibiotics Market Report," 2022.
[4] Hansen, L. et al. "Antibiotic Resistance in Streptococcus pneumoniae." Journal of Infectious Diseases, 2020.

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