BICILLIN L-A Drug Patent Profile

When do Bicillin L-a patents expire, and when can generic versions of Bicillin L-a launch?

Bicillin L-a is a drug marketed by King Pharms Llc and Wyeth Ayerst and is included in two NDAs.

The generic ingredient in BICILLIN L-A is penicillin g benzathine. There are ninety-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the penicillin g benzathine profile page.

Summary for BICILLIN L-A

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Patent Applications:	1,107
Drug Prices:	Drug price information for BICILLIN L-A
What excipients (inactive ingredients) are in BICILLIN L-A?	BICILLIN L-A excipients list
DailyMed Link:	BICILLIN L-A at DailyMed

See drug prices for BICILLIN L-A

Recent Clinical Trials for BICILLIN L-A

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

Sponsor	Phase
University of Tennessee	Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3

See all BICILLIN L-A clinical trials

Pharmacology for BICILLIN L-A

Drug Class

Penicillin-class Antibacterial

US Patents and Regulatory Information for BICILLIN L-A

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 L-A	penicillin g benzathine	INJECTABLE;INJECTION	050141-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
King Pharms Llc	BICILLIN L-A	penicillin g benzathine	INJECTABLE;INJECTION	050141-001	Approved Prior to Jan 1, 1982	BC	RX	Yes	Yes
Wyeth Ayerst	BICILLIN L-A	penicillin g benzathine	INJECTABLE;INJECTION	050131-001	Approved Prior to Jan 1, 1982		DISCN	No	No

BICILLIN L-A Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bicillin L-A

Introduction to Bicillin L-A

Bicillin L-A, also known as penicillin G benzathine injectable suspension, is a crucial antibiotic used in the treatment of various bacterial infections, including syphilis, bejel, and diphtheria. This medication is administered via deep intramuscular injection and is a key component in the global fight against bacterial diseases.

Market Demand and Growth

The demand for Bicillin L-A has seen a significant increase due to several factors:

Rise in Syphilis Infections

There has been a notable rise in syphilis infection rates, which has driven up the demand for Bicillin L-A. This increase is particularly evident in regions like North America, where syphilis cases have been on the rise, contributing to the growing need for this antibiotic[1][5].

Global Health Needs

Bacterial infections affect a large population worldwide, with the US alone experiencing about 2 million cases of antibiotic-resistant infections annually, resulting in 23,000 deaths. This underscores the critical need for effective antibiotics like Bicillin L-A[4].

Supply Chain Challenges

Despite the increasing demand, the supply of Bicillin L-A has been disrupted by several factors:

Manufacturing Issues

Pfizer, the manufacturer of Bicillin L-A, has faced manufacturing issues that have led to shortages. These issues include prioritization of production due to increased demand and competitive shortages. The company has prioritized the production of 2-mL and 4-mL syringes of Bicillin L-A to meet the heightened demand[1][5].

Anticipated Shortages

There are anticipated shortages of Bicillin L-A from December 20, 2024, to January 31, 2025, for the 1.2 million unit prefilled syringes, and the shortage of the 600,000 unit prefilled syringes is expected to continue until April 2025[2].

Financial Impact on Pfizer

The financial trajectory of Pfizer, particularly in relation to Bicillin L-A, is influenced by several factors:

Revenue Growth

Pfizer's overall revenue has seen fluctuations, with a significant decline in 2023 due to lower revenues from Comirnaty and Paxlovid. However, excluding these products, Pfizer's revenues grew by 7% operationally, driven by new product launches and in-line product growth. For 2024, Pfizer expects operational revenue growth of 8% to 10%, including the impact of the Seagen acquisition[3].

Specific Product Revenues

While the specific financial impact of Bicillin L-A shortages on Pfizer's revenue is not detailed, the overall antibiotic market, including benzathine penicillin G, is expected to grow at a CAGR of 3.3% from 2020 to 2027. This growth is driven by increasing cases of bacterial infections and the critical role of antibiotics like Bicillin L-A in treating these conditions[4].

Regional Market Dynamics

The global market for benzathine penicillin G, including Bicillin L-A, varies by region:

North America

North America, particularly the US and Canada, dominates the market due to high demand driven by increasing cases of syphilis and other bacterial infections. The region also benefits from advanced medical practices and a strong healthcare system[4].

Asia-Pacific

China is a significant producer of antibiotics, including benzathine penicillin G, and exports a substantial amount to the US. European companies also collaborate with Chinese manufacturers to procure necessary drug molecules[4].

Africa and Middle East

These regions have the least market share due to low disposable income, low awareness, and limited healthcare expenditure. However, recent government and healthcare policies are leading to improvements and potential growth in these markets[4].

Competitive Landscape

The competitive landscape for Bicillin L-A involves several key players:

Pfizer

As the primary manufacturer, Pfizer faces challenges in meeting the increased demand due to manufacturing issues and competitive shortages. The company's strategies include prioritizing production and collaborating with other entities to ensure a stable supply chain[1][5].

Other Market Players

Other companies involved in the production and distribution of benzathine penicillin G include various market leaders, followers, and new entrants. These players are analyzed through frameworks like PORTER, SWOT, and PESTEL to understand their market positions and strategies[4].

Impact of Shortages

The shortages of Bicillin L-A have significant implications:

Public Health

The shortage exacerbates the difficulty in treating syphilis and other bacterial infections, potentially leading to increased morbidity and mortality rates. Public health initiatives are challenged by the lack of available medication[1][5].

Economic Impact

The shortage can lead to economic burdens on healthcare systems and patients, particularly in low-income groups who may struggle to access alternative treatments. The global market dynamics are also affected as countries rely on imports to meet their healthcare needs[4].

Key Takeaways

• Increasing Demand: The rise in syphilis infections and other bacterial diseases drives up the demand for Bicillin L-A.
• Supply Chain Issues: Manufacturing issues and competitive shortages lead to anticipated and ongoing shortages of Bicillin L-A.
• Financial Impact: Pfizer's revenue is influenced by overall market trends, with expected growth in 2024 despite challenges from specific product shortages.
• Regional Dynamics: North America dominates the market, while Asia-Pacific and Africa/Middle East regions have varying levels of demand and supply.
• Competitive Landscape: Pfizer and other market players face challenges and opportunities in the global benzathine penicillin G market.

FAQs

1. What is the primary reason for the shortage of Bicillin L-A? The primary reason for the shortage is a combination of increased demand due to rising syphilis infection rates and manufacturing issues.

2. When is the estimated return-to-supply date for Bicillin L-A 600,000 unit prefilled syringes? The estimated return-to-supply date for Bicillin L-A 600,000 unit prefilled syringes is April 2025[2].

3. How does the shortage of Bicillin L-A impact public health? The shortage exacerbates the difficulty in treating syphilis and other bacterial infections, potentially leading to increased morbidity and mortality rates.

4. What is the expected revenue growth for Pfizer in 2024? Pfizer expects operational revenue growth of 8% to 10% in 2024, excluding contributions from Comirnaty and Paxlovid and including the impact of the Seagen acquisition[3].

5. Which regions dominate the global benzathine penicillin G market? North America, particularly the US and Canada, dominates the market due to high demand and advanced medical practices[4].

Sources

1. FDA: Bicillin® LA (penicillin G benzathine injectable suspension) Prefilled Syringes.
2. TGA: About the 2024-2025 shortage of Bicillin L-A (benzathine benzylpenicillin tetrahydrate) prefilled syringe injection.
3. Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Financial Guidance.
4. Maximize Market Research: Global Benzathine Penicillin G Market: Industry Analysis 2019 - 2027.
5. CIDRAP: Pfizer projects Bicillin L-A and Bicillin C-R shortages.