PENICILLIN G SODIUM - Generic Drug Details

What are the generic sources for penicillin g sodium and what is the scope of patent protection?

Penicillin g sodium is the generic ingredient in one branded drug marketed by Bristol Myers Squibb, Copanos, Pharmacia And Upjohn, Sandoz, and Watson Labs Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for penicillin g sodium. One supplier is listed for this compound.

Summary for PENICILLIN G SODIUM

US Patents:	0
Tradenames:	1
Applicants:	5
NDAs:	5
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	11
Patent Applications:	3,837
What excipients (inactive ingredients) are in PENICILLIN G SODIUM?	PENICILLIN G SODIUM excipients list
DailyMed Link:	PENICILLIN G SODIUM at DailyMed

Recent Clinical Trials for PENICILLIN G SODIUM

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

Sponsor	Phase
Cairo University	N/A
University of British Columbia	Early Phase 1
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all PENICILLIN G SODIUM clinical trials

Pharmacology for PENICILLIN G SODIUM

Drug Class

Penicillin-class Antibacterial

US Patents and Regulatory Information for PENICILLIN G SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Copanos	PENICILLIN G SODIUM	penicillin g sodium	INJECTABLE;INJECTION	061051-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmacia And Upjohn	PENICILLIN G SODIUM	penicillin g sodium	INJECTABLE;INJECTION	061046-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol Myers Squibb	PENICILLIN G SODIUM	penicillin g sodium	INJECTABLE;INJECTION	061935-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs Inc	PENICILLIN G SODIUM	penicillin g sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	063014-001	Sep 13, 1988		DISCN	No	No
Sandoz	PENICILLIN G SODIUM	penicillin g sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	065068-001	Feb 26, 2001		RX	No	Yes

PENICILLIN G SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Penicillin G Sodium

Introduction

Penicillin G Sodium, a cornerstone antibiotic in the pharmaceutical industry, is poised for significant market dynamics and financial shifts in the coming years. This article delves into the current state, future projections, and key factors influencing the market for Penicillin G Sodium.

Market Size and Growth

Global Market Volume

The global Penicillin G Sodium market volume was approximately 65 thousand tonnes in 2023, indicating a substantial presence in the antibiotic market[2].

Forecasted Growth

The market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 3.25% during the forecast period up to 2034. This growth is driven by the increasing prevalence of bacterial infections and the ongoing demand for effective antibiotics[2].

Regional Demand

Leading Consumer Region

North America is the leading consumer of Penicillin G Sodium globally, driven by high healthcare standards and a robust pharmaceutical market[2].

Seasonal Demand in the U.S.

In the U.S., the onset of colder months typically leads to an increase in bacterial infections, thereby driving up the demand for antibiotics like Penicillin G Sodium. This seasonal surge is crucial for the market's stability and growth[1].

Supply Chain and Production

Global Supply Chain

The U.S. market heavily relies on imports of Penicillin G Sodium APIs, primarily from China and India. However, supply chain disruptions, such as shipping delays and elevated freight costs, can pose significant challenges[1].

Domestic Production Initiatives

To mitigate supply chain vulnerabilities, U.S. policymakers and manufacturers are accelerating efforts to localize API production. Federal initiatives, including grants and subsidies, aim to reduce reliance on foreign imports and secure a stable domestic supply chain[1].

Pricing and Cost Dynamics

Production Costs

Fluctuations in production costs, including higher equipment prices for fermentation, can exert upward pressure on Penicillin G Sodium prices. However, competition among generic API manufacturers is expected to temper significant price hikes[1].

Pricing Adjustments

Analysts predict moderate price adjustments due to cost pressures, but these will be balanced by the competitive landscape of generic API manufacturers[1].

Regulatory and Policy Environment

Regulatory Developments

Regulatory developments play a crucial role in shaping the market dynamics of Penicillin G Sodium. Initiatives to enhance domestic production and reduce reliance on imports are expected to influence the market's trajectory[1].

Competitive Landscape

Generic APIs Dominance

The U.S. market for Penicillin G Sodium is dominated by generic APIs, with a strong focus on cost efficiency. Major players such as Abbott Laboratories, GlaxoSmithKline, and Pfizer Inc. are key competitors in this space[3].

Innovation and Production Capabilities

Market players are focusing on innovation and improving production capabilities to balance supply and demand. This includes investments in research and development to address emerging challenges like antibiotic resistance[3].

Route of Administration and Spectrum of Activity

Parenteral vs. Oral

The parenteral segment, which includes penicillin injections, dominated the market in terms of revenue in 2022 due to the treatment of severe bacterial infections. However, the oral segment is anticipated to grow rapidly due to its cost-effectiveness and ease of administration[3].

Broad-Spectrum Penicillins

The broad-spectrum penicillin segment, which includes medications like amoxicillin, dominated the market in 2022. This is attributed to the rise in prevalence of bacterial infections and the effectiveness of these medications[3].

Financial Projections

Global Penicillin Drug Market

The global penicillin drug market, which includes Penicillin G Sodium, was valued at $8.4 billion in 2022 and is projected to reach $12.1 billion by 2032, growing at a CAGR of 3.7%[3].

Penicillin Active Pharmaceutical Ingredients Market

The global penicillin active pharmaceutical ingredients market is expected to reach $3288.8 million by 2026, growing at a CAGR of 4.4% from 2019 to 2026[4].

Recent Investments and Agreements

Research and Development Investments

Companies like GSK and Sandoz have made significant investments in research and development to address infectious diseases and improve antibiotic manufacturing capacities. For instance, GSK announced a EUR 1 billion investment over ten years to accelerate R&D in infectious diseases[3].

Manufacturing Capacity Expansion

Sandoz has expanded its European manufacturing capacity for finished dosage form penicillin, and there are plans to further strengthen production capabilities in various regions[3].

Challenges and Opportunities

Antibiotic Resistance

Rising concerns about antibiotic resistance could prompt a gradual shift towards next-generation antibiotics. However, in the short term, this is unlikely to diminish the significance of legacy APIs like Penicillin G Sodium[1].

Market Expansion Opportunities

The increasing prevalence of bacterial infections worldwide remains a key driver for the growth of the penicillin drug market. The demand for effective antibiotics provides opportunities for market expansion and innovation[3].

Key Takeaways

• Seasonal Demand: The U.S. market for Penicillin G Sodium experiences a surge in demand during colder months due to increased bacterial infections.
• Supply Chain: The market is heavily reliant on imports from China and India, but domestic production initiatives are underway to reduce this reliance.
• Pricing Dynamics: Moderate price adjustments are expected due to production cost fluctuations, tempered by competition among generic API manufacturers.
• Regulatory Environment: Regulatory developments and federal initiatives are crucial in shaping the market trajectory and securing a stable supply chain.
• Financial Projections: The global penicillin drug market is projected to grow significantly, reaching $12.1 billion by 2032.

FAQs

Q: What is the current global market volume for Penicillin G Sodium?

A: The global Penicillin G Sodium market volume was approximately 65 thousand tonnes in 2023[2].

Q: Which region is the leading consumer of Penicillin G Sodium globally?

A: North America is the leading consumer of Penicillin G Sodium globally[2].

Q: What are the key drivers for the growth of the Penicillin G Sodium market?

A: The key drivers include the increasing prevalence of bacterial infections, seasonal demand, and the cost-effectiveness of Penicillin G Sodium[1][3].

Q: How is the competitive landscape of the Penicillin G Sodium market defined?

A: The market is dominated by generic APIs, with a focus on cost efficiency and innovation in production capabilities[1][3].

Q: What are the recent investments in the Penicillin G Sodium market?

A: Recent investments include GSK's EUR 1 billion investment in R&D and Sandoz's expansion of European manufacturing capacities[3].

Sources

1. ChemAnalyst: "USA Penicillin G Sodium Market to Exhibit Resilience in November 2024"[1]
2. ChemAnalyst: "Penicillin G Sodium Market Size, Share and Forecast to 2034"[2]
3. Allied Market Research: "Penicillin Drug Market Size, Share & Growth Report, 2032"[3]
4. Business Research Insights: "Penicillin Active Pharmaceutical Ingredients Market Growth, 2031"[4]