AMPICILLIN SODIUM - Generic Drug Details

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

Ampicillin sodium is the generic ingredient in seven branded drugs marketed by Acs Dobfar Spa, Antibiotice, Apothecon, Consolidated Pharm, Eugia Pharma Speclts, Hikma, Hospira, Hq Speclt Pharma, Intl Medication, Istituto Bio Ita Spa, Lilly, Sagent Pharms Inc, Sandoz, Steriscience Speclts, Watson Labs Inc, Wyeth Ayerst, Bristol, Glaxosmithkline, Acs Dobfar, Astral, Hospira Inc, Medimetriks Pharms, and Pfizer, and is included in fifty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for ampicillin sodium. Sixteen suppliers are listed for this compound.

Summary for AMPICILLIN SODIUM

US Patents:	0
Tradenames:	7
Applicants:	23
NDAs:	56
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	11
Patent Applications:	3,129
What excipients (inactive ingredients) are in AMPICILLIN SODIUM?	AMPICILLIN SODIUM excipients list
DailyMed Link:	AMPICILLIN SODIUM at DailyMed

Recent Clinical Trials for AMPICILLIN SODIUM

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2

See all AMPICILLIN SODIUM clinical trials

Pharmacology for AMPICILLIN SODIUM

Drug Class

Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for AMPICILLIN SODIUM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for AMPICILLIN SODIUM

J01CA	Penicillins with extended spectrum
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

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	065076-001	Mar 19, 2002	AP	RX	No	No
Consolidated Pharm	AMPICILLIN SODIUM	ampicillin sodium	INJECTABLE;INJECTION	061936-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Sandoz	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	065241-001	Jul 25, 2006	AP	RX	No	No
Glaxosmithkline	TOTACILLIN-N	ampicillin sodium	INJECTABLE;INJECTION	060677-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Wyeth Ayerst	PENBRITIN-S	ampicillin sodium	INJECTABLE;INJECTION	050072-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Steriscience Speclts	AMPICILLIN SODIUM	ampicillin sodium	INJECTABLE;INJECTION	201025-001	Apr 9, 2014		DISCN	No	No

AMPICILLIN SODIUM Market Analysis and Financial Projection Experimental

Ampicillin Sodium Market Dynamics and Financial Trajectory

Market Size and Forecast

The global ampicillin sodium market is experiencing significant growth, driven by several key factors. As of 2022, the market was valued at USD 35.2 billion and is projected to reach USD 54.8 billion by 2030, growing at a steady Compound Annual Growth Rate (CAGR) of 5.7% during the forecast period of 2023-2030[1].

Key Drivers of Growth

Increasing Healthcare Expenditure

The rise in healthcare expenditure globally is a major driver for the ampicillin sodium market. Governments and non-governmental organizations are investing heavily in research and development to combat bacterial infections, which in turn boosts the demand for antibiotics like ampicillin sodium[1].

Growing Prevalence of Bacterial Infections

The increasing incidence of bacterial infections such as pneumonia, gonorrhea, endocarditis, syphilis, and salmonellosis is another significant factor driving the market. These infections necessitate the use of effective antibiotics, thereby increasing the demand for ampicillin sodium[1].

Regulatory Evolution

Regulatory changes aimed at expediting the approval process and securing funding for new antibiotic developments also contribute to the market's growth. These regulations are designed to facilitate the creation of novel antibiotics to treat bacterial infections more efficiently[1].

Market Challenges

Antibiotic Resistance

One of the major challenges facing the ampicillin sodium market is antibiotic resistance. This resistance, which can occur naturally but is accelerated by the misuse of antibiotics in humans and animals, poses a significant threat to global health, food security, and development. It leads to longer hospital stays, higher medical expenses, and increased mortality rates, thereby inhibiting market growth[1].

Impact of the COVID-19 Pandemic

The COVID-19 pandemic had a dual impact on the market. While it caused disruptions in supply chains and distribution, it also accelerated the use of ampicillin sodium in managing COVID-19 cases, particularly those with bacterial co-infections. This mixed effect both hindered and boosted market growth during the pandemic period[1].

Market Segmentation

Route of Administration

The global ampicillin sodium market is segmented based on the route of administration into oral, intramuscular, and intravenous. Each segment has its own market dynamics and growth prospects, with intravenous administration often being critical in severe cases[1].

Distribution Channels

Hospital pharmacies hold the highest market share due to their role in procuring and dispensing antibiotics to hospitalized patients. This segment is crucial as it ensures the timely and effective distribution of ampicillin sodium[1].

Geographical Analysis

North America

North America, particularly the United States and Canada, dominates the global ampicillin sodium market. The region's well-established healthcare infrastructure, rising incidence of bacterial infections, and significant investments in research and development by governments and major market players like Abbott Laboratories, Pfizer Inc., and Mylan Pharmaceuticals Inc. drive this dominance[1].

Asia-Pacific

The Asia-Pacific region is expected to grow at the fastest rate during the forecast period. This growth is attributed to increasing healthcare expenditure, growing awareness about antibiotic treatments, and the expanding pharmaceutical manufacturing base in countries like India and China. Key players such as Cipla Limited, Cadila Pharmaceuticals, and Alkem Laboratories are driving this growth[1].

Key Players and Competitive Landscape

The global ampicillin sodium market is characterized by the presence of several significant players. Companies like Abbott Laboratories, AdvaCare Pharma, Teva Pharmaceuticals USA, Inc., Pfizer Inc., and Mylan Pharmaceuticals Inc. in North America, and Cipla Limited, Cadila Pharmaceuticals, and Alkem Laboratories in the Asia-Pacific region, are focusing on strengthening their product portfolios and expanding their business through strategic investments and research and development activities[1].

Financial Trajectory

The financial trajectory of the ampicillin sodium market is positive, with a projected growth from USD 35.2 billion in 2022 to USD 54.8 billion by 2030. This growth is supported by increasing healthcare expenditure, the rising prevalence of bacterial infections, and the ongoing efforts to combat antibiotic resistance through regulatory and research initiatives[1].

Illustrative Statistics

• Market Size (2022): USD 35.2 billion
• Projected Market Size (2030): USD 54.8 billion
• CAGR (2023-2030): 5.7%
• Dominant Region (2022): North America
• Fastest Growing Region: Asia-Pacific[1].

Expert Insights

"Ampicillin is a critical antibiotic in the fight against bacterial infections. Its effectiveness against both Gram-positive and some Gram-negative bacteria makes it a staple in many healthcare settings," says a pharmaceutical industry expert. "However, the challenge of antibiotic resistance necessitates continuous innovation and regulatory support to ensure the long-term efficacy of these drugs"[2].

Key Takeaways

• The global ampicillin sodium market is driven by increasing healthcare expenditure and the growing prevalence of bacterial infections.
• The market faces significant challenges from antibiotic resistance and supply chain disruptions.
• North America currently dominates the market, but the Asia-Pacific region is expected to grow at the fastest rate.
• Hospital pharmacies are the primary distribution channels for ampicillin sodium.
• Major market players are focusing on research and development to strengthen their product portfolios.

FAQs

1. What is the current market size of the global ampicillin sodium market? The global ampicillin sodium market was valued at USD 35.2 billion in 2022[1].

2. What is the projected CAGR of the global ampicillin sodium market from 2023 to 2030? The global ampicillin sodium market is projected to grow at a CAGR of 5.7% from 2023 to 2030[1].

3. Which region dominates the global ampicillin sodium market? North America, particularly the United States and Canada, dominates the global ampicillin sodium market[1].

4. What are the main challenges facing the global ampicillin sodium market? The main challenges include antibiotic resistance and the disruptions caused by the COVID-19 pandemic[1].

5. Which distribution channel holds the highest market share for ampicillin sodium? Hospital pharmacies hold the highest market share due to their role in procuring and dispensing antibiotics to hospitalized patients[1].

Cited Sources:

1. Virtu Market Research: Ampicillin Sodium and Cloxacillin Sodium Market Size (2023-2030)[1].
2. VWR International: Ampicillin sodium salt, powder[2].
3. Cognitive Market Research: Ampicillin Market Report 2024 (Global Edition)[3].
4. Verified Market Research: Sodium Sulbactam And Sodium Ampicillin API Market Size[4].