Penicillin g benzathine; penicillin g procaine - Generic Drug Details

What are the generic drug sources for penicillin g benzathine; penicillin g procaine and what is the scope of freedom to operate?

Penicillin g benzathine; penicillin g procaine is the generic ingredient in two branded drugs marketed by King Pharms Llc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for penicillin g benzathine; penicillin g procaine

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	penicillin g benzathine; penicillin g procaine at DailyMed

Recent Clinical Trials for penicillin g benzathine; penicillin g procaine

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

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2

See all penicillin g benzathine; penicillin g procaine clinical trials

Pharmacology for penicillin g benzathine; penicillin g procaine

Drug Class

Penicillin-class Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for penicillin g benzathine; penicillin g procaine

C05AD	Local anesthetics
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

N01BA	Esters of aminobenzoic acid
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for penicillin g benzathine; 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
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 900/300	penicillin g benzathine; penicillin g procaine	INJECTABLE;INJECTION	050138-003	Approved Prior to Jan 1, 1982		RX	Yes	Yes
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

Penicillin g benzathine; penicillin g procaine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Penicillin G Benzathine

Introduction

Penicillin G benzathine, also known as benzathine penicillin G (BPG), is a crucial antibiotic used in the treatment of various bacterial infections, including syphilis, rheumatic fever, and group A streptococcal infections. Despite its importance, the market for BPG is fraught with challenges that impact its supply, demand, and financial performance.

Global Demand and Supply Imbalances

The demand for BPG is significant, yet it is not fully met by current market supplies. Historically, BPG was used to treat a broad array of conditions, but the development of alternative antibiotics has narrowed its usage. However, it remains the primary treatment for syphilis and other specific infections.

• Demand Shortfalls: The existing market demand for BPG is projected to fulfill less than half of the actual requirement, highlighting a significant gap between supply and demand[1].

Manufacturing and Supply Chain Issues

The production of BPG is concentrated among a few manufacturers, primarily in China.

• Limited Manufacturers: By 2016, only three Chinese API manufacturers remained to supply the global market, a situation that persists today. This reduction is due to low profit margins and limited visibility of demand[1].
• Finished Pharmaceutical Products: While several companies produce the finished pharmaceutical product (FPP), the majority serve low- and middle-income countries with weaker regulatory systems, where prices are low and economic incentives to produce quality-assured products are undermined[1].

Market Dynamics

Competitive Landscape

The market for BPG is characterized by a competitive landscape with few dominant players.

• Dominant Players: Pfizer is the sole supplier of penicillin G benzathine injection in the US, highlighting the monopolistic nature of the market in some regions[5].
• Global Production: China is a major producer of antibiotics, including BPG, with many European companies collaborating with Chinese firms for procurement[3].

Regional Analysis

The market for BPG varies significantly across different regions.

• North America: This region, particularly the US and Canada, dominates the market due to increasing cases of syphilis and bacterial infections[3].
• Low- and Middle-Income Countries: These regions account for the bulk of the demand but face challenges such as low prices, weak regulatory systems, and limited access to quality-assured products[1].
• Europe and Africa: European companies often collaborate with Chinese manufacturers, while Africa and the Middle East have lower market shares due to economic and awareness factors[3].

Financial Trajectory

Market Size and Growth

The global BPG market is expected to grow, albeit at a moderate pace.

• Market Size: The global BPG market was valued at a significant amount in 2019 and is expected to grow at a CAGR of 3.3% from 2020 to 2027[3].
• Future Projections: By 2032, the market is projected to reach USD 3.60 billion at a CAGR of 7.2% during the forecast period 2023-2032[4].

Revenue Impact and Economic Factors

The market is influenced by various economic and regulatory factors.

• COVID-19 Impact: The COVID-19 pandemic has had a revenue impact on market leaders, followers, and disrupters, reflecting in the overall market analysis[3].
• Price and Profit Margins: Low prices, especially in low- and middle-income countries, and low profit margins for manufacturers are significant challenges. Prices in these markets are typically less than US$1 per dose[1].

Shortages and Their Implications

Current Shortages

The BPG market is currently experiencing significant shortages.

• Pfizer's Shortage: Pfizer has announced an extension of the Bicillin® L-A shortage, with supplies not expected to recover until the 4th quarter of 2024. This shortage is due to increased demand and allocation of resources towards manufacturing adult presentations[2][5].
• Alternative Treatments: During the shortage, oral doxycycline is recommended as an alternative treatment for non-pregnant adults with syphilis, while Bicillin® L-A and Extencilline® are prioritized for pregnant individuals and infants exposed to syphilis[2].

Impact on Patient Care

The shortages have significant implications for patient care.

• Prioritization: Healthcare providers are advised to prioritize Bicillin® L-A and Extencilline® for specific patient groups, such as pregnant individuals and infants exposed to syphilis, due to the critical nature of these treatments[2].
• Alternative Agents: The FDA has allowed the temporary importation of non-FDA approved Extencilline from France to mitigate the shortage[5].

Regulatory and Public Health Responses

Health Advisories and Guidelines

Public health entities have issued guidelines to manage the shortage.

• CDC and FDA Guidelines: The CDC and FDA have provided clinical reminders and recommendations for evaluating supply and using alternative products like doxycycline when possible[2][5].

Mitigation Strategies

Several strategies are being implemented to address the shortages and market imbalances.

• Supply Chain Management: Efforts to improve supply chain visibility and demand forecasting are crucial to mitigate future shortages[1].
• Regulatory Support: Regulatory bodies are working to ensure the availability of quality-assured products, with only one BPG product currently receiving WHO prequalification[1].

Key Takeaways

• The global demand for BPG exceeds current supply, leading to recurring shortages.
• The market is dominated by a few manufacturers, primarily in China.
• Low profit margins and limited visibility of demand have reduced the number of API manufacturers.
• The market is expected to grow moderately, driven by increasing cases of syphilis and bacterial infections.
• Regulatory and public health responses are critical in managing shortages and ensuring patient care.

FAQs

What is the primary use of Penicillin G Benzathine?

Penicillin G benzathine is primarily used for the treatment of syphilis, rheumatic fever, and group A streptococcal infections.

Why is there a shortage of Penicillin G Benzathine?

The shortage is due to increased demand, low profit margins, and limited visibility of demand, which have reduced the number of active pharmaceutical ingredient (API) manufacturers.

What are the alternative treatments during the shortage?

Oral doxycycline is recommended as an alternative treatment for non-pregnant adults with syphilis, while Bicillin® L-A and Extencilline® are prioritized for pregnant individuals and infants exposed to syphilis.

How is the global market for Penicillin G Benzathine expected to grow?

The global BPG market is expected to grow at a CAGR of 7.2% from 2023 to 2032, reaching USD 3.60 billion by 2032.

What regulatory measures are being taken to address the shortage?

Regulatory bodies are working to ensure the availability of quality-assured products, and the FDA has allowed the temporary importation of non-FDA approved Extencilline to mitigate the shortage.

Sources

1. Securing the supply of benzathine penicillin: a global perspective on the challenges and opportunities - Academic.oup.com
2. Extension of Long-Acting Benzathine Penicillin G (Bicillin® L-A) Shortage - CDPH
3. Benzathine Penicillin G Market: Industry Analysis 2019 - 2027 - Maximizemarketresearch.com
4. Benzathine Penicillin G Market Analysis, Share and Industry Forecast till 2032 - Marketresearchfuture.com
5. Drug Shortage Detail: Penicillin G Benzathine - ASHP.org