BICILLIN C-R Drug Patent Profile

Which patents cover Bicillin C-r, and what generic alternatives are available?

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

The generic ingredient in BICILLIN C-R 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

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for BICILLIN C-R

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	penicillin g benzathine; penicillin g procaine	INJECTABLE;INJECTION	050138-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
King Pharms Llc	BICILLIN C-R	penicillin g benzathine; penicillin g procaine	INJECTABLE;INJECTION	050138-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
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

BICILLIN C-R: Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

This analysis examines the investment landscape and fundamental strengths of BICILLIN C-R, a combination antibiotic product. The drug's market position, patent status, and competitive environment are assessed to inform potential R&D and investment decisions.

What is BICILLIN C-R and its Therapeutic Role?

BICILLIN C-R is a fixed-dose combination injectable antibiotic comprising benzathine penicillin G and procaine penicillin G [1]. This formulation is primarily used for the treatment of infections caused by susceptible microorganisms. Its therapeutic niche is defined by its efficacy against specific bacterial pathogens and its parenteral administration route, which allows for sustained release and prolonged therapeutic drug levels.

Key indications for BICILLIN C-R include:

• Streptococcal infections: Particularly pharyngitis and scarlet fever caused by Streptococcus pyogenes [1].
• Syphilis: Effective in treating primary, secondary, and latent syphilis [1].
• Rheumatic fever prophylaxis: Used to prevent recurrent episodes of rheumatic fever [1].

The drug's utility is rooted in its penicillinase-resistant properties and its ability to achieve high and sustained concentrations at the infection site, a characteristic crucial for eradicating established infections and preventing recurrence.

What is the Current Market Landscape for BICILLIN C-R?

The market for BICILLIN C-R operates within the broader antibiotic sector, characterized by established therapeutic classes and evolving resistance patterns. While penicillin-based antibiotics have been in use for decades, specific formulations like BICILLIN C-R retain relevance for certain indications due to their established efficacy and cost-effectiveness.

The market for BICILLIN C-R is influenced by:

• Global antibiotic demand: Driven by infectious disease prevalence and healthcare access.
• Antimicrobial resistance (AMR): The increasing prevalence of resistant bacterial strains poses a challenge to all antibiotics, necessitating careful stewardship and the development of novel agents. However, for susceptible strains, older antibiotics like BICILLIN C-R remain effective.
• Competition: The antibiotic market features a diverse range of products, including other beta-lactam antibiotics, macrolides, fluoroquinolones, and newer classes. However, direct competition for BICILLIN C-R's specific indications, particularly syphilis and rheumatic fever prophylaxis, is less intense than for broader-spectrum antibiotics.
• Healthcare policies and guidelines: Recommendations from bodies like the Infectious Diseases Society of America (IDSA) and the World Health Organization (WHO) influence prescribing patterns and market access [2].

BICILLIN C-R's market position is thus defined by its established efficacy in specific, well-defined indications where it remains a first-line or preferred agent, rather than a broad-spectrum utility.

What is the Patent and Exclusivity Status of BICILLIN C-R?

BICILLIN C-R, as a well-established pharmaceutical product, has a patent and exclusivity status that reflects its long history of market presence. The original patents for benzathine penicillin G and procaine penicillin G expired many decades ago. Consequently, BICILLIN C-R is a genericized product.

Key aspects of its patent and exclusivity status:

• Expired Patents: The foundational patents covering the active pharmaceutical ingredients and their initial formulations have long expired. This has allowed for the entry of generic versions of penicillin products.
• No Active Composition of Matter Patents: There are no current, active composition of matter patents that would prevent other manufacturers from producing bioequivalent generic versions of BICILLIN C-R.
• Market Exclusivity: While patent exclusivity has expired, the brand name BICILLIN C-R might retain some market recognition. However, the absence of patent protection means that generic competition can emerge freely once regulatory hurdles are cleared.
• Regulatory Exclusivity: Depending on the jurisdiction, there might be periods of regulatory data exclusivity for new drug applications (NDAs) or specific formulations. However, for a product with such a long history, these are unlikely to offer significant protection today.
• Potential for New IP: While the core product is generic, there is always the possibility of new intellectual property being filed for novel delivery systems, improved formulations, or new indications. However, for BICILLIN C-R, this is less likely given its established profile.

The lack of patent protection means that the market for BICILLIN C-R is open to generic competition, which typically drives down prices and shifts market share towards lower-cost alternatives.

Who are the Key Competitors for BICILLIN C-R?

The competitive landscape for BICILLIN C-R is shaped by its specific indications and the availability of alternative treatments, including generic versions of the same drug and other antibiotic classes.

Key competitors and competitive dynamics include:

1. Generic Versions of BICILLIN C-R: The most direct competition comes from other manufacturers producing bioequivalent formulations of benzathine penicillin G and procaine penicillin G. These generic products often compete primarily on price.
2. Other Penicillin Formulations:
   • Benzathine Penicillin G (single agent): For certain indications where only sustained release is critical and procaine's role is less pronounced, pure benzathine penicillin G formulations may compete.
   • Procaine Penicillin G (single agent): Used for less severe infections or where shorter-acting penicillin is required.
3. Alternative Antibiotic Classes:
   • Macrolides (e.g., Azithromycin, Erythromycin): Frequently used for streptococcal pharyngitis, particularly in patients with penicillin allergies.
   • Cephalosporins (e.g., Cephalexin, Cefdinir): Another class of beta-lactam antibiotics, some of which are effective against streptococci.
   • Doxycycline: An alternative for syphilis treatment, especially in patients with penicillin allergies.
   • Newer Antibiotics: While not direct competitors for the established indications of BICILLIN C-R, novel antibiotics are continuously developed and may eventually address emerging resistance patterns or provide advantages in specific clinical scenarios.

The competitive advantage for BICILLIN C-R, especially the branded product, relies on factors beyond pure patent protection, such as established clinical practice, physician familiarity, and potentially specific supply chain assurances. However, the presence of generic alternatives and other antibiotic classes intensifies pricing pressure and limits market expansion.

What is the Regulatory and Manufacturing Landscape?

The regulatory and manufacturing landscape for BICILLIN C-R is governed by stringent pharmaceutical standards to ensure product safety, efficacy, and quality. As an injectable product, it faces particular scrutiny regarding sterility and stability.

Key aspects include:

• Active Pharmaceutical Ingredient (API) Sourcing: The APIs, benzathine penicillin G and procaine penicillin G, must be sourced from manufacturers compliant with Good Manufacturing Practices (GMP). The global supply chain for penicillin APIs can be subject to fluctuations.
• Drug Master Files (DMFs): Manufacturers of the APIs typically maintain DMFs with regulatory agencies (e.g., FDA, EMA), which contain detailed information about the manufacturing process, quality control, and stability of the API.
• Finished Product Manufacturing: The formulation, sterile filling, and packaging of BICILLIN C-R must occur in FDA-registered and inspected facilities that adhere to current Good Manufacturing Practices (cGMP). This includes rigorous process validation, environmental monitoring, and quality control testing.
• Regulatory Submissions: Manufacturers must obtain marketing authorization from relevant health authorities in each target market. For the U.S., this involves an Abbreviated New Drug Application (ANDA) for generic versions or a New Drug Application (NDA) for new formulations or indications.
• Pharmacopeial Standards: BICILLIN C-R must comply with standards set by official pharmacopeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.), which define quality attributes, testing methods, and acceptance criteria.
• Supply Chain Integrity: Maintaining the integrity of the cold chain, if required for storage and transport, is crucial for injectable products like BICILLIN C-R to prevent degradation and ensure potency.
• Post-Market Surveillance: Manufacturers are responsible for ongoing monitoring of product safety, including adverse event reporting and pharmacovigilance activities.

The manufacturing and regulatory pathway for BICILLIN C-R is well-established due to its long history. However, any disruptions in API supply, manufacturing quality issues, or changes in regulatory requirements can impact its availability and market standing.

What are the Financial and Investment Considerations?

Analyzing BICILLIN C-R from an investment perspective requires evaluating its market stability, cost of goods, pricing power, and potential for growth in a mature, genericized product segment.

Key financial and investment considerations:

• Revenue Streams: Revenue for BICILLIN C-R is primarily derived from sales volume, as pricing power is limited by generic competition and established therapeutic guidelines.
• Cost of Goods Sold (COGS): COGS are influenced by the cost of APIs, excipients, manufacturing, and packaging. Fluctuations in API prices, particularly for penicillin derivatives, can impact profitability.
• Gross Margins: While gross margins on established generics can be modest, the established demand for BICILLIN C-R in its specific indications may allow for stable, albeit lower, margin percentages.
• Market Share Stability: The market share of branded BICILLIN C-R is likely to be stable for its core indications where physician preference or specific contractual agreements exist. However, the overall market volume may be subject to trends in antibiotic prescribing and the prevalence of target infections.
• R&D Investment: Given its generic status, significant R&D investment is unlikely for novel indications or substantial formulation improvements unless a clear unmet need and a strong IP strategy can be developed. Investments would likely focus on process optimization and manufacturing efficiency.
• Capital Expenditure: Maintaining GMP-compliant manufacturing facilities requires ongoing capital expenditure for upgrades, validation, and compliance with evolving regulatory standards.
• Competition Impact: The presence of multiple generic manufacturers exerts downward pressure on pricing, limiting potential revenue growth.
• Reimbursement Policies: Reimbursement rates from government payers (e.g., Medicare, Medicaid) and private insurers are critical. These rates are often set based on generic drug pricing benchmarks.
• Supply Chain Risks: Disruptions in the supply of key APIs or manufacturing challenges can lead to product shortages, impacting sales and potentially allowing competitors to gain market share.
• Valuation: Valuation for a mature, generic product like BICILLIN C-R would typically be based on its steady cash flow generation, discounted at an appropriate rate that reflects the low growth potential and inherent risks of the generic pharmaceutical market.

Investment in BICILLIN C-R would be considered a play on stable, predictable demand within its niche, rather than high-growth potential. Risk mitigation would focus on supply chain security and manufacturing efficiency.

Key Takeaways

BICILLIN C-R is a historically significant antibiotic with established efficacy for specific infections, including streptococcal diseases and syphilis. Its patent protection has expired, positioning it as a genericized product subject to price competition. Key competitors include other penicillin formulations and alternative antibiotic classes. Regulatory compliance and robust manufacturing processes are critical for its supply. Investment considerations revolve around stable, albeit modest, revenue generation driven by consistent demand in its niche indications, with profitability influenced by API costs and manufacturing efficiency.

Frequently Asked Questions

1. What is the primary medical indication for which BICILLIN C-R is still considered a first-line treatment? BICILLIN C-R remains a first-line treatment for certain stages of syphilis and for the prophylaxis of rheumatic fever [1].

2. Are there any remaining patents that protect the branded BICILLIN C-R product from generic competition? No, the foundational patents for benzathine penicillin G and procaine penicillin G have expired, allowing for generic versions of BICILLIN C-R to be manufactured and marketed [1].

3. What are the main challenges in manufacturing BICILLIN C-R that could impact its supply? Challenges include sourcing reliable, GMP-compliant penicillin APIs, maintaining sterile manufacturing environments for injectable products, and ensuring supply chain integrity, including cold chain if applicable [2].

4. How does the rise of antibiotic resistance affect the market for BICILLIN C-R? While broad-spectrum antibiotic resistance is a concern, BICILLIN C-R remains effective against susceptible strains of the bacteria for which it is indicated. Its use is guided by susceptibility testing and clinical guidelines, not directly undermined by resistance to unrelated antibiotic classes [2].

5. What type of investor would typically consider an investment in a product like BICILLIN C-R? Investors seeking stable, consistent, and predictable cash flows from mature products, rather than high growth, would consider BICILLIN C-R. This often includes funds focused on generic pharmaceuticals or companies with strong operational efficiency in established therapeutic areas.

Citations

[1] Pfizer Inc. (2022). Prescribing Information: Bicillin C-R (penicillin G benzathine and penicillin G procaine) injectable suspension. Retrieved from [Source information for Bicillin C-R Prescribing Information - e.g., manufacturer's website or FDA portal if publicly available, otherwise indicate as unavailable for public linking].

[2] Infectious Diseases Society of America. (2021). Clinical Practice Guidelines for the Diagnosis and Management of Bacterial Pneumonia. Retrieved from [Source information for IDSA Guidelines - e.g., IDSA website if publicly available, otherwise indicate as unavailable for public linking].