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Last Updated: December 18, 2025

BICILLIN L-A Drug Patent Profile


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When do Bicillin L-a patents expire, and when can generic versions of Bicillin L-a launch?

Bicillin L-a is a drug marketed by King Pharms Llc and Wyeth Ayerst and is included in two NDAs.

The generic ingredient in BICILLIN L-A is penicillin g benzathine. There are ninety-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the penicillin g benzathine profile page.

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Summary for BICILLIN L-A
Drug patent expirations by year for BICILLIN L-A
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Recent Clinical Trials for BICILLIN L-A

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SponsorPhase
Washington University School of MedicinePHASE3
University of TennesseePhase 2
National Institute of Allergy and Infectious Diseases (NIAID)Phase 3

See all BICILLIN L-A clinical trials

Pharmacology for BICILLIN L-A

US Patents and Regulatory Information for BICILLIN L-A

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
King Pharms Llc BICILLIN L-A penicillin g benzathine INJECTABLE;INJECTION 050141-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
King Pharms Llc BICILLIN L-A penicillin g benzathine INJECTABLE;INJECTION 050141-001 Approved Prior to Jan 1, 1982 BC RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Ayerst BICILLIN L-A penicillin g benzathine INJECTABLE;INJECTION 050131-001 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 BICILLIN L-A

Last updated: August 3, 2025

Overview of BICILLIN L-A

BICILLIN L-A is an injectable penicillin formulation, primarily consisting of benzathine penicillin G, used extensively in the treatment of bacterial infections such as syphilis, rheumatic fever prophylaxis, and certain streptococcal infections. It has long-standing use in both developed and emerging markets owing to its efficacy, low cost, and established safety profile. The drug’s market is characterized by its continued relevance despite evolving antibiotic resistance patterns and the emergence of newer antimicrobial agents.

Market Landscape and Key Drivers

The global demand for BICILLIN L-A is driven by several factors:

  • Prevalence of Infectious Diseases: Despite medical advances, syphilis remains prevalent in multiple regions, including parts of Africa, Southeast Asia, and Eastern Europe. As per WHO data, syphilis cases in pregnant women, if untreated, lead to adverse outcomes, implying persistent demand for penicillin-based treatments like BICILLIN L-A.[1]

  • Treatment Guidelines and Clinical Practice: Major guidelines, notably those from CDC and WHO, continue to endorse penicillin G benzathine as the first-line treatment for syphilis, especially during pregnancy, reinforcing its market stability.[2]

  • Brand Recognition and Cost-Effectiveness: BICILLIN L-A’s longstanding history in medical practice makes it a trusted, affordable choice, particularly in low- and middle-income countries where healthcare budgets are constrained.

  • Emerging Resistance and Alternative Therapies: Resistance to antibiotics like macrolides and doxycycline is complicating treatment options elsewhere, solidifying penicillin’s role where susceptibility is maintained. However, there is ongoing surveillance to monitor resistance trends.

Market Challenges and Constraints

Despite steady demand, several challenges influence the financial trajectory of BICILLIN L-A:

  • Antibiotic Resistance: The emergence of penicillin-resistant strains of bacteria could diminish its effectiveness, impacting sales. While resistance in Treponema pallidum (the causative agent of syphilis) remains low, concerns persist.[3]

  • Regulatory and Patent Landscape: BICILLIN L-A is off-patent, leading to increased competition from generic manufacturers, which exerts pressure on pricing and margins.

  • Global Healthcare Access: Variations in healthcare infrastructure inhibit procurement and administration of injectable forms, especially in low-resource settings, limiting market growth potential.

  • Advent of Newer Modalities: The development of oral antibiotics and long-acting formulations may challenge the niche for injectable penicillin G benzathine in specific indications.

Financial Trajectory and Market Projections

Historical Performance

The market for BICILLIN L-A has remained relatively stable over the past decade, anchored by its essential-use status and global relevance. In 2020, global sales of penicillin-based injectables were estimated at approximately $400-$500 million, with BICILLIN L-A accounting for a significant share due to its widespread use.[4] Growth was modest, around 2-3% annually, influenced substantially by demand in emerging markets.

Forecasted Trends (2023–2030)

  • Steady Market Demand: Given the persistent burden of syphilis and other bacterial infections, demand is expected to continue. Healthcare initiatives targeting maternal health will sustain procurement, especially in low-income countries.

  • Market Growth Rates: Industry analysts project a compound annual growth rate (CAGR) of roughly 1.5-2% for the global BICILLIN L-A market, driven by the expanding treatment coverage in underserved populations and stabilization of resistance patterns.[5]

  • Emerging Markets as Growth Engines: Countries in Africa, Southeast Asia, and Latin America are expected to account for up to 60% of future demand due to high disease prevalence rates and expanding healthcare infrastructure investments.

  • Impact of Global Health Policies: Initiatives such as the WHO’s Global Strategy for Syphilis Prevention could positively influence procurement activities, potentially accelerating market growth.

  • Competitive Dynamics: The increasing presence of generics and potential biosimilars could compress prices, impacting revenue margins. Manufacturers focusing on cost efficiencies and wider distribution channels may gain competitive advantages.

Regulatory and Supply Chain Considerations

Regulatory approvals for BICILLIN L-A are well-established in major markets, including the US, Europe, and many emerging nations. However, supply chain stability remains critical; disruptions due to manufacturing issues, geopolitical tensions, or pandemics can affect availability, and consequently, the overall revenue trajectory.

Additionally, the WHO’s prequalification of key manufacturers facilitates wider procurement in UNICEF and other international health programs, bolstering supply stability and market penetration.

Strategic Outlook

For pharmaceutical companies involved in BICILLIN L-A, the strategic focus should pivot towards:

  • Market Expansion: Targeted efforts to increase adoption in high-burden regions by collaborating with governments and NGOs.

  • Product Differentiation: Ensuring consistent supply, competitive pricing, and adherence to quality standards to maintain trust among healthcare providers.

  • R&D and Innovation: While the core product remains vital, exploring formulations like long-acting injectable variants or oral alternatives could diversify offerings.

  • Partnerships and Licensing Agreements: Strengthening distribution networks via alliances can improve access and profitability.

Conclusion

BICILLIN L-A remains a cornerstone in infectious disease management, especially for syphilis. Its market is characterized by stability rooted in ongoing need, balanced against challenges from resistance, competition, and evolving healthcare landscapes. The projected modest growth reflects both the durability of its clinical utility and the headwinds from market dynamics. Success hinges on strategic adaptation—optimizing supply chains, engaging emerging markets, and fostering initiatives aligned with global health goals.


Key Takeaways

  • Stable Demand: BICILLIN L-A continues to be essential for infectious disease treatment, especially in resource-constrained regions.
  • Modest Growth Outlook: Projected CAGR of 1.5–2% through 2030 driven by expanding healthcare access in emerging markets.
  • Competitive Landscape: Generic manufacturing pressures and lower innovation investment may constrain margins.
  • Regulatory Stability: Established approval pathways support ongoing market presence.
  • Strategic Opportunities: Focused efforts in high-burden regions, supply chain resilience, and R&D for new formulations can enhance long-term profitability.

FAQs

1. What factors influence the demand for BICILLIN L-A globally?
Demand stems from disease prevalence (e.g., syphilis), adherence to treatment guidelines recommending penicillin, cost-effectiveness, and healthcare infrastructure in target regions, particularly in low- and middle-income countries.

2. How does antibiotic resistance impact BICILLIN L-A’s market?
Low resistance rates in target bacteria support continued use; however, emerging resistance could threaten its efficacy, potentially leading to reduced demand or shifts toward alternative therapies.

3. Who are the main competitors to BICILLIN L-A?
Generic manufacturers produce similar benzathine penicillin G formulations, creating pricing pressures. No significant branded competition exists due to its off-patent status.

4. What are the potential growth opportunities for BICILLIN L-A?
Expanding access in underserved regions, strengthening supply chains, and developing long-acting or oral alternatives can open new revenue streams.

5. How do global health initiatives influence BICILLIN L-A’s market?
Efforts like WHO’s disease elimination campaigns and procurement programs (e.g., UNICEF) facilitate access, stabilize demand, and support market extension.


Sources:
[1] WHO. “Syphilis and Other Sexually Transmitted Infections,” 2021.
[2] CDC. “Treatment of Syphilis,” 2020.
[3] Peeling, R. et al. “Syphilis,” The Lancet, 2017.
[4] GlobalData Healthcare. “Penicillin Market Report,” 2022.
[5] MarketsandMarkets. “Antimicrobial Market Forecast,” 2023.

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