Penicillin g benzathine - Generic Drug Details

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

Penicillin g benzathine is the generic ingredient in five branded drugs marketed by King Pharms Llc, Wyeth Ayerst, and Casper Pharma Llc, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for penicillin g benzathine. Two suppliers are listed for this compound.

Summary for penicillin g benzathine

US Patents:	0
Tradenames:	5
Applicants:	3
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	19
Patent Applications:	56
What excipients (inactive ingredients) are in penicillin g benzathine?	penicillin g benzathine excipients list
DailyMed Link:	penicillin g benzathine at DailyMed

Recent Clinical Trials for penicillin g benzathine

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

Sponsor	Phase
Kaohsiung Veterans General Hospital.	N/A
China Medical University Hospital	N/A
Taoyuan General Hospital	N/A

See all penicillin g benzathine clinical trials

Pharmacology for penicillin g benzathine

Drug Class

Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for penicillin g benzathine

Anti-Bacterial Agents

US Patents and Regulatory Information for penicillin g benzathine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Casper Pharma Llc	PERMAPEN	penicillin g benzathine	INJECTABLE;INJECTION	060014-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wyeth Ayerst	BICILLIN	penicillin g benzathine	SUSPENSION;ORAL	050126-002	Approved Prior to Jan 1, 1982		DISCN	No	No
King Pharms Llc	BICILLIN L-A	penicillin g benzathine	INJECTABLE;INJECTION	050141-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
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
Wyeth Ayerst	BICILLIN L-A	penicillin g benzathine	INJECTABLE;INJECTION	050131-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Penicillin g benzathine Market Analysis and Financial Projection Experimental

Benzathine Penicillin G Market Dynamics and Financial Trajectory

Introduction to Benzathine Penicillin G

Benzathine Penicillin G (BPG) is a long-acting formulation of penicillin G, widely used for the treatment and prophylaxis of various bacterial infections, including syphilis, rheumatic fever, and respiratory infections. Its enduring importance in antibiotic therapy is underscored by its effectiveness against certain bacterial strains and its cost-effectiveness compared to newer antibiotics.

Market Trends and Growth Drivers

Increasing Prevalence of Bacterial Infections

The global Benzathine Penicillin G market is driven by the rising prevalence of bacterial infections. In the US alone, approximately 2 million people suffer from antibiotic-resistant infections each year, resulting in 23,000 deaths[3][4].

Renewed Interest Due to Antibiotic Resistance

The increasing levels of resistance to other antibiotics have led to a renewed interest in the use of BPG, especially in cases where other drugs have failed. This trend is expected to continue as healthcare professionals seek effective treatments against antimicrobial-resistant diseases[1].

Cost-Effectiveness

BPG is cost-effective compared to newer antibiotics, making it a preferred choice in many healthcare settings. This factor is particularly significant in regions with limited healthcare budgets[1].

Regional Market Analysis

North America

North America dominates the Benzathine Penicillin G market, primarily due to the increasing cases of syphilis and other bacterial infections, along with advancements in medical practices. The region's well-developed healthcare infrastructure and access to treatments also contribute to its market leadership[1][4].

Europe

Europe is the second-largest market for BPG, driven by the high incidence of infectious diseases such as rheumatic fever. According to the European Centre for Disease Prevention and Control, 850,000 cases of infectious diseases were reported in Europe in 2014, supporting the growth of the BPG market in this region[1].

Asia-Pacific

The Asia-Pacific region is the fastest-growing market for BPG, driven by the rising prevalence of bacterial infections and changing lifestyles. China has emerged as a key producer of antibiotics, including BPG, with significant exports to other regions[1][4].

Middle East and Africa

The Middle East and Africa region holds the least share in the BPG market due to low healthcare expenditure and limited awareness of therapeutic treatments. However, government initiatives and increasing investments in healthcare are expected to drive growth in this region[1].

Market Segmentation

Mode of Injection

BPG is administered primarily through intramuscular injection, although it can also be given intravenously in certain cases. The intramuscular route is the most common due to its long-acting nature[4].

End Users

The primary end users of BPG include hospitals, clinics, ambulatory surgical centers, diagnostic centers, and research centers. These institutions drive the demand for BPG due to its widespread use in treating various bacterial infections[4].

Key Market Players

The Benzathine Penicillin G market is characterized by the presence of several key players, including:

• Pfizer Inc
• Alembic IT Department
• ECPlaza Network Inc
• Abcam plc
• Sandoz International GmbH
• Merck KGaA
• Triveni Interchem Private Limited
• CSC Pharmaceuticals
• North China Pharmaceutical Group Semisyntech Co. Ltd
• CSPC Pharmaceuticals Group Ltd.[1][4]

Financial Trajectory

Market Size and Growth Rate

The global Benzathine Penicillin G market was valued at USD xx billion in 2019 and is expected to grow at a CAGR of 3.3% from 2020 to 2027. However, more recent projections indicate a higher growth rate, with the market expected to reach USD 3.60 billion by 2032 at a CAGR of 7.2% during the forecast period 2023-2032[1][3].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the BPG market. While it has disrupted supply chains, leading to shortages, it has also highlighted the importance of effective antibiotic treatments, thereby driving demand[3].

Challenges and Shortages

Global Shortages

The availability of BPG has been a significant challenge, particularly in the treatment of syphilis. Shortages have been reported worldwide, including in China, where the availability of BPG in hospitals has shown some improvement but remains a concern[5].

Supply Chain Disruptions

Disruptions in the supply chain have exacerbated the shortage of BPG, making treatment of syphilis and other bacterial infections more challenging. These disruptions are a major factor affecting the market's growth and stability[4].

Pharmacokinetics and Clinical Use

Serum Levels and Efficacy

Studies have shown that serum penicillin G levels become less than protective within two weeks of administering 1.2 million units of BPG. This has significant implications for treatment and prophylaxis guidelines, suggesting a need for more frequent dosing or alternative formulations[2].

Standard Guidelines

Standard guidelines recommend intramuscular administration of 1.2 million units initially and every 3 or 4 weeks, depending on the illness and the individual's health status. However, these guidelines may need to be revised based on recent pharmacokinetic studies[2].

Conclusion

The Benzathine Penicillin G market is poised for significant growth driven by the increasing prevalence of bacterial infections, the cost-effectiveness of the drug, and its renewed importance in the face of antibiotic resistance. However, the market faces challenges such as global shortages and supply chain disruptions.

Key Takeaways

• Growing Demand: The market is driven by the rising cases of bacterial infections and the need for effective antibiotic treatments.
• Regional Variations: North America and Europe are the largest markets, while the Asia-Pacific region is the fastest-growing.
• Key Players: Several major pharmaceutical companies are involved in the production and distribution of BPG.
• Financial Trajectory: The market is expected to grow significantly, reaching USD 3.60 billion by 2032.
• Challenges: Global shortages and supply chain disruptions are major challenges affecting the market.

FAQs

Q: What is Benzathine Penicillin G used for? A: Benzathine Penicillin G is used for the treatment of various bacterial infections, including syphilis, rheumatic fever, and respiratory infections.

Q: Why is there a renewed interest in Benzathine Penicillin G? A: The increasing levels of resistance to other antibiotics have led to a renewed interest in BPG as an effective treatment option.

Q: Which region dominates the Benzathine Penicillin G market? A: North America dominates the BPG market due to the high incidence of bacterial infections and advancements in medical practices.

Q: What are the challenges facing the Benzathine Penicillin G market? A: The market faces challenges such as global shortages and supply chain disruptions, which affect the availability of the drug.

Q: Who are the key players in the Benzathine Penicillin G market? A: Key players include Pfizer Inc, Alembic IT Department, ECPlaza Network Inc, Abcam plc, Sandoz International GmbH, and others.

Sources

1. Market Research Future: Benzathine Penicillin G Market Trends | Market Research Future
2. PLOS ONE: Serum Penicillin G Levels Are Lower Than Expected in Adults within Two Weeks of Administration of 1.2 Million Units
3. Maximize Market Research: Benzathine Penicillin G Market: Industry Analysis 2019 - 2027
4. OpenPR: Benzathine Penicillin G Market- Industry Analysis and forecast 2019
5. Mohammed Bin Rashid Library: Asset Details - MBRL - Mohammed Bin Rashid Library