Ampicillin/ampicillin trihydrate; probenecid - Generic Drug Details

What are the generic drug sources for ampicillin/ampicillin trihydrate; probenecid and what is the scope of freedom to operate?

Ampicillin/ampicillin trihydrate; probenecid is the generic ingredient in three branded drugs marketed by Apothecon, Bristol, and Cosette, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ampicillin/ampicillin trihydrate; probenecid

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	5
DailyMed Link:	ampicillin/ampicillin trihydrate; probenecid at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for ampicillin/ampicillin trihydrate; probenecid

J01CA	Penicillins with extended spectrum
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

M04AB	Preparations increasing uric acid excretion
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ampicillin/ampicillin trihydrate; probenecid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	POLYCILLIN-PRB	ampicillin/ampicillin trihydrate; probenecid	FOR SUSPENSION;ORAL	050457-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	PRINCIPEN W/ PROBENECID	ampicillin/ampicillin trihydrate; probenecid	CAPSULE;ORAL	050488-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Cosette	PROBAMPACIN	ampicillin/ampicillin trihydrate; probenecid	FOR SUSPENSION;ORAL	061741-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	POLYCILLIN-PRB	ampicillin/ampicillin trihydrate; probenecid	FOR SUSPENSION;ORAL	061898-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	PRINCIPEN W/ PROBENECID	ampicillin/ampicillin trihydrate; probenecid	CAPSULE;ORAL	062150-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Ampicillin and Probenecid

Introduction

Ampicillin and probenecid are two medications that, when combined, form a potent treatment for various bacterial infections. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare providers.

Ampicillin Market Overview

Ampicillin, an antibiotic belonging to the penicillin class, is widely used to treat bacterial infections such as gonorrhea, pneumonia, meningitis, and salmonella infections.

Market Size and Growth

The ampicillin market is forecasted to grow at a Compound Annual Growth Rate (CAGR) of 3.5% from 2024 to 2030, reaching a market size of $385.82 million by 2030. This growth is driven by the increased demand for antibiotics post-COVID-19, particularly for managing secondary infections and as part of combination therapies in hospitals and healthcare facilities[3].

Drivers of Growth

• Post-COVID-19 Demand: The COVID-19 pandemic has heightened the awareness and concern about bacterial infections, leading to an increased demand for antibiotics like ampicillin.
• Combating Antibiotic Resistance: As healthcare authorities focus on controlling antibiotic resistance, the demand for effective antibiotics such as ampicillin is on the rise[3].

Market Segmentation

The ampicillin market is segmented by type, indication, end users, intake method, and geography. Key segments include:

• Indications: Gonorrhea, pneumonia, meningitis, salmonella infections, and endocarditis.
• Intake Methods: Oral, intramuscular injection, and intravenous administration.
• Geography: Global markets with significant focus on North America, Europe, and the Asia-Pacific region[3].

Probenecid Market Dynamics

Probenecid is a uricosuric agent that, when combined with antibiotics like ampicillin, enhances their effectiveness by reducing their excretion through urine.

Role in Combination Therapy

Probenecid is often used in combination with antibiotics to increase their plasma concentrations and prolong their half-life. For example, when used with ampicillin, probenecid decreases the renal clearance of ampicillin, allowing for less frequent dosing and improved therapeutic outcomes[2][5].

Limitations and Side Effects

Probenecid has several limitations, including the risk of urolithiasis (kidney stones) and significant drug-drug interactions. It interacts with multiple transporters and alters the clearance of other medications, such as penicillin, furosemide, and methotrexate[1].

Financial Trajectory of Ampicillin and Probenecid Combination

The financial trajectory of the ampicillin and probenecid combination is influenced by several factors:

Production and Supply Chain

The production of ampicillin and probenecid involves various suppliers and manufacturers. The market analysis includes supplier bargaining power, buyer bargaining power, and the threat of substitutes, which all impact the financial health of the market[4].

Pricing and Revenue

The pricing of ampicillin and probenecid combination products varies by region and manufacturer. The market is expected to see stable revenue growth driven by the increasing demand for antibiotics. For instance, the global ampicillin market is projected to reach $385.82 million by 2030[3].

Competitive Landscape

The competitive landscape includes various pharmaceutical companies such as Dr. Reddy's Laboratories Ltd, Algen Healthcare Limited, and Geno Pharmaceuticals Ltd, which offer different variants of ampicillin and probenecid combinations. The competition is driven by factors such as product efficacy, pricing, and distribution channels[5].

Key Takeaways

• Growing Demand: The demand for ampicillin is increasing due to post-COVID-19 needs and the fight against antibiotic resistance.
• Combination Therapy: Probenecid enhances the effectiveness of ampicillin by reducing its renal clearance.
• Market Segmentation: The market is segmented by type, indication, end users, intake method, and geography.
• Financial Growth: The ampicillin market is expected to grow at a CAGR of 3.5% from 2024 to 2030, reaching $385.82 million by 2030.
• Competitive Landscape: Multiple pharmaceutical companies are involved in the production and distribution of ampicillin and probenecid combinations.

FAQs

1. What is the primary use of the ampicillin and probenecid combination?

   • The combination is primarily used to treat various bacterial infections by preventing the formation of the bacterial protective covering and enhancing the plasma concentrations of ampicillin[5].

2. How does probenecid affect the pharmacokinetics of ampicillin?

   • Probenecid decreases the renal clearance of ampicillin, leading to higher plasma concentrations and a longer half-life, thus allowing for less frequent dosing[2].

3. What are the common side effects of the ampicillin and probenecid combination?

   • Common side effects include diarrhea, nausea, vomiting, stomach pain, loss of appetite, headache, and allergic reactions[5].

4. What is the projected market size of the ampicillin market by 2030?

   • The ampicillin market is forecasted to reach $385.82 million by 2030, growing at a CAGR of 3.5% from 2024 to 2030[3].

5. Why is there an increased demand for ampicillin post-COVID-19?

   • The increased demand is driven by the need to manage secondary bacterial infections and as part of combination therapies in hospitals and healthcare facilities treating COVID-19 patients[3].

Cited Sources

1. Review of Urate-Lowering Therapeutics: From the Past to the Future - Frontiers in Pharmacology
2. Effect of probenecid on disposition kinetics of ampicillin in horses - PubMed
3. Ampicillin Market Size Report, 2024-2030 - IndustryARC
4. Ampicillin and Probenecid Capsules Market - Prof Research
5. Ampicillin + Probenecid - 1mg