PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - Generic Drug Details

What are the generic sources for piperacillin sodium; tazobactam sodium and what is the scope of freedom to operate?

Piperacillin sodium; tazobactam sodium is the generic ingredient in three branded drugs marketed by Astral, Eugia Pharma, Eugia Pharma Speclts, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Provepharm Sas, Sagent Pharms Inc, Sandoz, Shandong, Steriscience Speclts, Wockhardt Bio Ag, Wyeth Pharms, and Baxter Hlthcare Corp, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Summary for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	24
Finished Product Suppliers / Packagers:	17
Clinical Trials:	5
DailyMed Link:	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM at DailyMed

Recent Clinical Trials for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
St. Justine's Hospital	Phase 1
Phillip Brian Smith	Phase 1

See all PIPERACILLIN SODIUM; TAZOBACTAM SODIUM clinical trials

Pharmacology for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for PIPERACILLIN SODIUM; TAZOBACTAM 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

Paragraph IV (Patent) Challenges for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOSYN	For Injection	piperacillin sodium; tazobactam sodium	12 g/1.5 g per vial (pharmacy bulk)	050684	1	2011-12-06

US Patents and Regulatory Information for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira Inc	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	065386-002	Sep 15, 2009		DISCN	No	No
Hospira Inc	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	065386-001	Sep 15, 2009		DISCN	No	No
Eugia Pharma	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	217409-002	Oct 12, 2023		DISCN	No	No
Istituto Bio Ita Spa	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	090498-001	May 31, 2011	AP	RX	No	No
Fresenius Kabi Usa	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	206204-001	May 11, 2018		DISCN	No	No
Shandong	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	217243-001	Apr 14, 2023	AP	RX	No	No

Expired US Patents for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-002	Feb 24, 1998	8,133,883
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-004	Oct 22, 1993	6,900,184
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998	6,207,661
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-002	Feb 24, 1998	6,900,184
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-003	Feb 24, 1998	6,900,184
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-002	Oct 22, 1993	7,915,229

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Piperacillin Sodium and Tazobactam Sodium

Introduction

Piperacillin sodium, a broad-spectrum penicillin antibiotic, and tazobactam sodium, a β-lactamase inhibitor, are combined to form a potent antibacterial agent used in treating various serious bacterial infections. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of the piperacillin sodium and tazobactam sodium market.

Market Size and Projection

The global piperacillin sodium market has been experiencing steady growth. As of 2021, the market size was valued at USD 194.7 million and is projected to reach USD 272.4 million by 2031, exhibiting a Compound Annual Growth Rate (CAGR) of 3.4% during this period[4].

Driving Factors

Several factors are driving the growth of the piperacillin sodium market:

Increasing Demand for Antibiotics

The rising incidence of bacterial infections, particularly hospital-acquired infections (HAIs), is a significant driver. Piperacillin sodium, combined with tazobactam, is effective against a wide range of gram-positive and gram-negative bacteria, making it a crucial treatment option[1][4].

Expansion of Healthcare Infrastructure

Growing investments in healthcare infrastructure, especially in emerging markets, are increasing accessibility to antibiotics. This expansion is vital for managing bacterial infections effectively and is a key factor in the market's growth[1].

Innovations in Drug Formulations

Recent advancements in drug formulations, such as extended-release formulations and combination therapies with β-lactamase inhibitors, are enhancing the efficacy and safety of piperacillin sodium. These innovations are making treatments more effective against resistant strains of bacteria[1].

Regional Market Dynamics

North America

North America holds a significant market share due to its advanced healthcare infrastructure, high healthcare expenditure, and a robust pharmaceutical industry. The region's strong healthcare system and high demand for effective antibiotics contribute to its dominant position in the market[1].

Europe

European countries are witnessing an increasing emphasis on antibiotic stewardship programs, which encourage the appropriate use of antibiotics. This focus on responsible antibiotic use is boosting demand for effective treatments like piperacillin sodium and tazobactam[1].

Asia-Pacific

The Asia-Pacific region is expected to exhibit the highest growth rate, driven by rising infection rates, increasing healthcare investments, and a growing patient population. This region offers substantial growth potential due to rising healthcare needs and increasing access to antibiotics[1].

Financial Trajectory

Revenue Growth

The market is expected to grow from USD 194.7 million in 2021 to USD 272.4 million by 2031, with a CAGR of 3.4%. This growth is driven by the increasing demand for antibiotics and the expanding healthcare infrastructure in various regions[4].

Investment Opportunities

Several investment opportunities are emerging in the piperacillin sodium market:

Research and Development

Investing in R&D for new formulations and delivery mechanisms can yield high returns as the demand for effective antibiotics continues to rise. Innovations in drug formulations and combination therapies are key areas of focus[1].

Manufacturing Capabilities

Companies expanding their manufacturing facilities to meet increased demand can benefit from economies of scale, leading to improved profitability. This is particularly relevant in regions with growing healthcare needs[1].

Emerging Markets

Investing in emerging markets, such as Asia-Pacific and Latin America, offers substantial growth potential due to rising healthcare needs and increasing access to antibiotics[1].

Competitive Landscape

Key Players

The top companies operating in the piperacillin sodium market include Qilu Pharmaceutical, Pfizer Healthcare, Fresenius Kabi AG, and Aurobindo Pharma. These companies are driving innovation and market growth through their research and development efforts and strategic partnerships[4].

Generic Alternatives and Patent Expiry

As patents for branded piperacillin sodium products expire, the market is witnessing a surge in generic alternatives. This shift is expected to make the drug more accessible and affordable, particularly in low- and middle-income countries[1].

Pharmacokinetics and Dosage

Piperacillin and tazobactam are administered intravenously, with peak plasma concentrations attained immediately after completion of the infusion. The dosage and administration of piperacillin/tazobactam require careful consideration, especially in patients with renal or hepatic impairment. For instance, dosage adjustments are recommended when creatinine clearance is below 40 mL/min[3].

Challenges and Opportunities

Antibiotic Resistance

Antibiotic resistance poses a significant threat to public health, making infections harder to treat and leading to longer hospital stays, higher medical costs, and increased mortality. However, this challenge also presents an opportunity for the development of more effective antibiotics and stewardship programs[1].

Partnerships and Collaborations

Collaborations between pharmaceutical companies and healthcare institutions are becoming increasingly common. These partnerships aim to facilitate research and development efforts, improve antibiotic stewardship, and enhance education on appropriate antibiotic usage among healthcare professionals[1].

Key Takeaways

• The global piperacillin sodium market is projected to grow from USD 194.7 million in 2021 to USD 272.4 million by 2031.
• The market is driven by increasing demand for antibiotics, expansion of healthcare infrastructure, and innovations in drug formulations.
• North America, Europe, and the Asia-Pacific region are key markets, with the Asia-Pacific region expected to exhibit the highest growth rate.
• Investment opportunities include research and development, expanding manufacturing capabilities, and targeting emerging markets.
• Generic alternatives and strategic partnerships are crucial for market growth and accessibility.

FAQs

What is the projected market size of the piperacillin sodium market by 2031?

The global piperacillin sodium market is projected to reach USD 272.4 million by 2031[4].

What is the CAGR of the piperacillin sodium market from 2021 to 2031?

The piperacillin sodium market is expected to exhibit a CAGR of 3.4% from 2021 to 2031[4].

Which regions are driving the growth of the piperacillin sodium market?

North America, Europe, and the Asia-Pacific region are driving the growth of the piperacillin sodium market, with the Asia-Pacific region expected to show the highest growth rate[1].

What are the key driving factors of the piperacillin sodium market?

Increasing demand in the treatment of various infections and the growing number of hospital-acquired infections (HAIs) are the key driving factors of the piperacillin sodium market[4].

Which companies are the top players in the piperacillin sodium market?

The top companies operating in the piperacillin sodium market include Qilu Pharmaceutical, Pfizer Healthcare, Fresenius Kabi AG, and Aurobindo Pharma[4].

Sources

1. Market Research Intellect: "Piperacillin Sodium Market Size And Projection"
2. FDA: "Piperacillin and Tazobactam for Injection"
3. Pfizer: "ZOSYN® (Piperacillin and Tazobactam for Injection, USP)"
4. Business Research Insights: "Piperacillin Sodium Market Size & Global Analysis [2031]"
5. Paediatric: "Piperacillin tazobactam Monograph"