AMPICILLIN SODIUM; SULBACTAM SODIUM - Generic Drug Details

What are the generic drug sources for ampicillin sodium; sulbactam sodium and what is the scope of patent protection?

Ampicillin sodium; sulbactam sodium is the generic ingredient in two branded drugs marketed by Acs Dobfar, Antibiotice, Astral, Eugia Pharma Speclts, Hikma, Hospira Inc, Hq Speclt Pharma, Istituto Bio Ita Spa, Medimetriks Pharms, Sandoz, Steriscience Speclts, and Pfizer, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

Twelve suppliers are listed for this compound.

Summary for AMPICILLIN SODIUM; SULBACTAM SODIUM

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	25
Finished Product Suppliers / Packagers:	12
Clinical Trials:	2
DailyMed Link:	AMPICILLIN SODIUM; SULBACTAM SODIUM at DailyMed

Recent Clinical Trials for AMPICILLIN SODIUM; SULBACTAM SODIUM

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

Sponsor	Phase
DongGuk University
Pfizer	Phase 3

See all AMPICILLIN SODIUM; SULBACTAM SODIUM clinical trials

Pharmacology for AMPICILLIN SODIUM; SULBACTAM SODIUM

Drug Class	Penicillin-class Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AMPICILLIN SODIUM; SULBACTAM SODIUM

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

J01CG	Beta-lactamase inhibitors
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for AMPICILLIN SODIUM; SULBACTAM SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	065074-002	Mar 19, 2002	AP	RX	No	No
Hikma	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	065074-001	Mar 19, 2002	AP	RX	No	No
Antibiotice	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	201406-001	Dec 7, 2015	AP	RX	No	No
Hospira Inc	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	090646-001	Dec 21, 2011		DISCN	No	No
Eugia Pharma Speclts	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	090339-001	Sep 20, 2010	AP	RX	No	No

AMPICILLIN SODIUM; SULBACTAM SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ampicillin Sodium and Sulbactam Sodium

Market Overview

The market for ampicillin sodium and sulbactam sodium, often combined in formulations like UNASYN, is driven by several key factors that influence its growth and financial trajectory.

Growth Drivers

Increased Demand for Antibiotics

The COVID-19 pandemic has heightened the demand for antibiotics, including ampicillin, to manage secondary bacterial infections in COVID-19 patients. This increased demand is expected to continue, driving the market growth at a CAGR of 3.5% from 2024 to 2030, with the market projected to reach $385.82 million by 2030[1].

Prevalence of Bacterial Infections and Antibiotic Resistance

The prevalence of bacterial infections and the emergence of antibiotic resistance are significant drivers of the ampicillin market. As healthcare authorities focus on controlling antibiotic resistance, the demand for effective antibiotics like ampicillin and its combinations with sulbactam is on the rise[1][4].

Market Segmentation

By Type

The market is segmented by type, including Ampicillin Sodium, Ampicillin Sodium for Injection, Ampicillin Sodium and Sulbactam Sodium for injection, and other combinations. These variations cater to different clinical needs and patient populations[1].

By Indication

Ampicillin and sulbactam are used to treat a wide range of infections, including gonorrhea, pneumonia, meningitis, salmonella infections, and endocarditis. This broad spectrum of indications contributes to the market's growth[1].

By End Users

The market is segmented by end users, including adults and children, reflecting the drug's versatility in treating infections across different age groups[1].

By Intake Method

The drugs can be administered orally (capsules, tablets, syrup, drops) or via injection (intramuscularly or intravenously), which affects their distribution and usage patterns[1].

By Distribution Channel

The distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies, each playing a crucial role in the drug's accessibility and market reach[1].

Financial Trajectory

Market Size and Growth

The global ampicillin market was valued at USD 169.9 million in 2022 and is projected to reach USD 219.52 million by 2032, growing at a CAGR of 2.6% during the forecast period[4].

Cost-Effectiveness

Studies have shown that ampicillin/sulbactam combinations are cost-effective compared to other antibiotics. For instance, a cost-effectiveness analysis revealed that the mean per-patient treatment cost for ampicillin/sulbactam was $14,084, significantly lower than $17,008 for imipenem/cilastatin, primarily due to lower drug and hospitalization costs[3].

Key Players

The ampicillin market is dominated by several key players, including DSM, ACS Dobfar, Kopran, Antibioticos, United Laboratories, Shandong Lukang, CSPC Pharmaceutical, North China Pharmaceutical, and Huaxing Pharmaceutical. These companies play a crucial role in manufacturing, distribution, and innovation within the market[4].

Clinical Pharmacology and Efficacy

Serum Concentrations and Half-Life

After administration, peak serum concentrations of ampicillin and sulbactam are attained quickly. For example, after a 15-minute intravenous infusion of UNASYN, peak serum levels of ampicillin range from 109 to 150 mcg/mL. The mean serum half-life of both drugs is approximately 1 hour in healthy volunteers[2].

Excretion and Protein Binding

Approximately 75 to 85% of both ampicillin and sulbactam are excreted unchanged in the urine within the first 8 hours after administration. Both drugs are reversibly bound to human serum protein, with ampicillin bound at about 28% and sulbactam at about 38%[2].

Antibacterial Spectrum

The combination of ampicillin and sulbactam extends the antibacterial spectrum to include bacteria normally resistant to ampicillin alone. Sulbactam inhibits beta-lactamases, making the combination effective against a broader range of bacterial infections[2][5].

Safety and Precautions

Adverse Effects

The use of ampicillin and sulbactam can lead to various adverse effects, including gastrointestinal disorders, blood and lymphatic system disorders, and immune system reactions. Clostridium difficile-associated diarrhea (CDAD) is a significant concern, and patients should be monitored for signs of superinfection[5].

Regional Analysis

The market for ampicillin and sulbactam is analyzed across various regions, including North America, South America, Europe, APAC, and the Middle East & Africa. Each region has its own market dynamics, influenced by local healthcare policies, infection rates, and antibiotic resistance patterns[1].

Key Takeaways

• Growing Demand: The market is driven by increased demand for antibiotics post-COVID-19 and the need to combat antibiotic resistance.
• Cost-Effectiveness: Ampicillin/sulbactam combinations are cost-effective compared to other antibiotics.
• Broad Spectrum: The combination extends the antibacterial spectrum, making it effective against a wider range of infections.
• Safety Concerns: Monitoring for adverse effects, particularly CDAD, is crucial.
• Regional Variations: Market dynamics vary by region, influenced by local healthcare policies and infection rates.

FAQs

What is the projected market size of the ampicillin market by 2032?

The ampicillin market is expected to reach USD 219.52 million by 2032[4].

What is the CAGR of the ampicillin market from 2024 to 2032?

The ampicillin market is expected to exhibit a CAGR of 2.6% from 2024 to 2032[4].

What are the primary drivers of the ampicillin market?

The primary drivers include the prevalence of bacterial infections and the emergence of antibiotic resistance[4].

How does the combination of ampicillin and sulbactam enhance antibacterial efficacy?

The combination extends the antibacterial spectrum by inhibiting beta-lactamases, making it effective against bacteria normally resistant to ampicillin alone[2][5].

What are the common adverse effects associated with ampicillin and sulbactam?

Common adverse effects include gastrointestinal disorders, blood and lymphatic system disorders, and immune system reactions, with a significant risk of CDAD[5].

Sources

1. IndustryARC: Ampicillin Market Size Report, 2024-2030.
2. Pfizer Medical Information: UNASYN ® Clinical Pharmacology.
3. PubMed: Cost-effectiveness of ampicillin/sulbactam versus imipenem/cilastatin.
4. Business Research Insights: Ampicillin Market Size, Share, Growth & Trends | Forecast, 2032.
5. Pfizer: UNASYN IM/IV - Pfizer.