BICILLIN C-R 900/300 Drug Patent Profile

Which patents cover Bicillin C-r 900/300, and when can generic versions of Bicillin C-r 900/300 launch?

Bicillin C-r 900/300 is a drug marketed by King Pharms Llc and is included in one NDA.

The generic ingredient in BICILLIN C-R 900/300 is penicillin g benzathine; penicillin g procaine. There are ninety-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the penicillin g benzathine; penicillin g procaine profile page.

Summary for BICILLIN C-R 900/300

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for BICILLIN C-R 900/300

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 C-R 900/300	penicillin g benzathine; penicillin g procaine	INJECTABLE;INJECTION	050138-003	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Investment Scenario and Fundamentals Analysis for BICILLIN C-R 900/300

Last updated: February 4, 2026

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What is BICILLIN C-R 900/300?

BICILLIN C-R 900/300 is a combination of benzathine penicillin G and procaine penicillin G. It is used primarily for treating bacterial infections such as syphilis, rheumatic fever, and skin infections. Its formulation allows for sustained release of penicillin, enabling long-acting antimicrobial coverage.

Market Overview

The global penicillin market, including long-acting formulations like BICILLIN, is driven by infectious disease prevalence, antibiotic resistance levels, and healthcare infrastructure. As of 2022, the global demand for penicillins reached approximately 15 billion units, with the long-acting segment accounting for about 20%.

Key Trends:

• Stabilizing antibiotic consumption due to antimicrobial stewardship.
• Rising resistance to oral penicillins increases reliance on injectable forms.
• Expansion in emerging markets enhances growth prospects.
• Patent status influences pricing and availability; BICILLIN C-R is off-patent, creating a generic market.

Market Drivers and Challenges

Drivers:

1. Infectious Disease Burden: High prevalence in low- and middle-income countries (LMICs) sustains demand.
2. Long-Acting Formulation Preference: Offers convenience and improved compliance compared to multiple daily doses.
3. Post-Pandemic Recovery: Resumption of routine vaccinations and treatments boosts sales.

Challenges:

1. Antibiotic Resistance: May restrict usage or lower demand if resistance impacts clinical guidelines.
2. Regulatory Landscape: Variability in approval status across countries affects market access.
3. Pricing Pressure: Competition from generics and price controls impact margins.

Competitive Landscape

• Generic Producers: Large pharmaceutical companies dominate, with multiple approved generic versions.
• Brand Leaders: Pfizer is historically associated with BICILLIN, but market share is dispersed.
• Emerging Biosimilars: Not applicable—biosimilars are for biologics, antibiotics are small molecules.

Regulatory and Patent Status

• BICILLIN C-R has no active patents globally, facilitating generic manufacturing.
• Regulatory approval varies; in the US, the drug is marketed as Bicillin LA, with additional approvals in Europe, Asia, Latin America.
• Regulatory hurdles mainly involve compliance with local pharmacovigilance and manufacturing standards.

Manufacturing and Supply Chain Considerations

• Production requires specialized facilities to ensure sterility and potency.
• Raw material supply (penicillin precursors) is generally stable but susceptible to disruptions caused by geopolitical or economic issues.
• Serialization and cold chain logistics are critical for maintaining quality during distribution.

Investment Fundamentals

Criterion	Analysis
Market Size & Growth	Stable, with incremental growth of 2-3% annually, driven by emerging markets.
Competitive Position	Widely available; low entry barriers for generic manufacturers.
Regulatory Environment	Favorable in many regions, but cyclical approval processes can cause delays.
Pricing & Margins	Competitive pressures reduce margins; off-patent status encourages price erosion.
R&D & Innovation	Limited; no significant therapeutic innovation expected. Investment focused on manufacturing efficiencies.
Entry Barriers	Low, due to widespread patent expiry and established manufacturing pathways.

Investment Risks

• Market Saturation: High competition limits price premiums.
• Regulatory Delays: Bipartisan approval processes can slow market access.
• Resistance Development: Alters prescribing behavior, potentially reducing demand.
• Pricing Pressures: Governments' push for lower drug prices constrains profitability.

Strategic Considerations

• Expand in Emerging Markets: Growth hinges on improving access where infectious diseases are prevalent.
• Optimize Manufacturing: Reduce costs via process enhancements.
• Diversify Portfolio: Complement BICILLIN line with other long-acting antibiotics.
• Monitor Resistance Trends: Adjust marketing and clinical guidelines accordingly.

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Key Takeaways

• BICILLIN C-R 900/300 is an established, off-patent long-acting penicillin formulation.
• Market growth is modest but steady, aided by unmet needs in LMICs.
• Competition from generics is intense, constraining pricing.
• Regulatory and supply chain issues are manageable but require vigilance.
• R&D investment is minimal; focus on manufacturing efficiencies and market expansion.

FAQs

1. What is the primary therapeutic use of BICILLIN C-R 900/300?
   Treatment of bacterial infections like syphilis, rheumatic fever, and skin infections with long-acting penicillin.

2. What factors influence the growth of BICILLIN's market share?
   Demand depends on infection prevalence, resistance patterns, regulatory approvals, and pricing strategies.

3. Are there significant patent restrictions affecting BICILLIN?
   No; patent expiry allows multiple generic manufacturers to produce the drug.

4. How does antibiotic resistance impact BICILLIN’s market?
   Resistance reduces clinical efficacy, potentially decreasing demand or prompting shifts to alternative therapies.

5. What are the main risks for investing in BICILLIN-based products?
   Market saturation, regulatory delays, resistance development, and pricing pressures.

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References

1. Global Market Insights: Antibiotics Market Size & Industry Analysis, 2022.
2. WHO Antibiotic Resistance Surveillance Reports, 2022.
3. U.S. FDA Drug Approvals Database.
4. European Medicines Agency (EMA) Regulations and Approvals.
5. Pharmaceutical Industry Reports, 2021-2022.