ZOSYN Drug Patent Profile

Which patents cover Zosyn, and what generic alternatives are available?

Zosyn is a drug marketed by Wyeth Pharms and Baxter Hlthcare Corp and is included in two NDAs.

The generic ingredient in ZOSYN is piperacillin sodium; tazobactam sodium. There are sixteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.

Summary for ZOSYN

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	6
Patent Applications:	1
Drug Prices:	Drug price information for ZOSYN
What excipients (inactive ingredients) are in ZOSYN?	ZOSYN excipients list
DailyMed Link:	ZOSYN at DailyMed

See drug prices for ZOSYN

Paragraph IV (Patent) Challenges for ZOSYN

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 ZOSYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-001	Oct 22, 1993		DISCN	Yes	No
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-002	Feb 24, 1998		RX	Yes	Yes
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-004	Oct 22, 1993		DISCN	Yes	No
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-002	Oct 22, 1993		DISCN	Yes	No

Expired US Patents for ZOSYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-004	Oct 22, 1993
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-002	Oct 22, 1993
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-003	Oct 22, 1993
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-001	Oct 22, 1993

International Patents for ZOSYN

See the table below for patents covering ZOSYN around the world.

Country	Patent Number	Title	Estimated Expiration
Colombia	5700796	COMPOSICIONES QUE CONTIENEN PIPERACILINA Y TAZOBACTAM UTILES PARA INYECCIONES
Denmark	1468697
China	1802179	Compositions containing piperacillin and tazobactam useful for injection
Poland	1468697

ZOSYN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZOSYN (Piperacillin and Tazobactam)

Introduction to ZOSYN

ZOSYN, a combination of piperacillin and tazobactam, is a broad-spectrum antibiotic used to treat various infections caused by susceptible bacteria. It is available in several formulations, including single-dose vials and, more recently, premixed solutions in Galaxy containers by Baxter International Inc.[4].

Market Size and Growth

The penicillin drug market, which includes ZOSYN, is projected to grow significantly over the coming years. The market size is expected to reach USD 10.71 billion in 2024 and grow at a CAGR of 3.21% to reach USD 12.55 billion by 2029. This growth is driven by the increasing burden of infectious diseases and the need for effective antibiotic treatments[3].

Key Market Drivers

• Increasing Burden of Infectious Diseases: The rising incidence of infections such as pneumonia, urinary tract infections, and gonorrhea drives the demand for broad-spectrum antibiotics like ZOSYN.
• Investments in Manufacturing: Recent investments by companies like Sandoz to increase the manufacturing capacity of essential antibiotics, including penicillins, are expected to boost market growth[3].
• Research and Development: Ongoing research activities, such as the potential use of β-lactams like penicillins as SARS-CoV-2 main protease inhibitors, could further enhance market demand[3].

Market Challenges

• Antimicrobial Resistance: The increasing resistance to antimicrobials is a significant challenge that could restrain market growth.
• Regulatory Frameworks: Stringent regulatory frameworks can also pose barriers to the development and approval of new antibiotic products[3].

Regional Market Dynamics

• North America: This region holds the largest market share in the penicillin drug market, driven by advanced healthcare infrastructure and high demand for effective antibiotic treatments[3].
• Asia-Pacific: This region is expected to grow at the highest CAGR over the forecast period due to increasing healthcare needs and investments in healthcare infrastructure[3].

Product Innovations and Convenience

The launch of ZOSYN premix by Baxter International Inc. is a significant development in the market. This ready-to-use formulation simplifies medication preparation, reduces the risk of contamination and dosing errors, and improves operational efficiencies for healthcare providers. The use of Baxter’s proprietary Galaxy containers, which are non-PVC and non-DEHP, also extends the shelf life of the premixed medications[4].

Financial Performance of Key Players

Pfizer Inc.

Pfizer, one of the major players in the penicillin drug market, has shown mixed financial results in recent years. For example, in 2013, Pfizer reported revenues of $51.584 billion, with adjusted diluted EPS of $2.22. However, the company faced challenges such as declining revenues in certain segments and significant changes in operating environments[2].

Baxter International Inc.

Baxter, which recently launched the ZOSYN premix, reported fourth-quarter sales of $3.89 billion in 2023, representing a 4% increase on a reported basis. The full-year sales from continuing operations were $14.81 billion, with an adjusted diluted EPS of $2.60. These figures indicate a stable financial trajectory for Baxter, supported by its expanding anti-infective portfolio[5].

Revenue Contribution of ZOSYN

While specific revenue figures for ZOSYN are not publicly disclosed, the product is part of the broader penicillin drug market, which is expected to grow substantially. The introduction of the premix formulation by Baxter is likely to contribute positively to the company's revenue, given its potential to improve patient safety and operational efficiencies[4].

Key Takeaways

• Market Growth: The penicillin drug market, including ZOSYN, is expected to grow at a CAGR of 3.21% from 2024 to 2029.
• Drivers: Increasing burden of infectious diseases, investments in manufacturing, and ongoing research activities drive market growth.
• Challenges: Antimicrobial resistance and stringent regulatory frameworks are key challenges.
• Regional Dynamics: North America holds the largest market share, while Asia-Pacific is the fastest-growing region.
• Product Innovations: The launch of ZOSYN premix by Baxter enhances patient safety and operational efficiencies.
• Financial Performance: Key players like Pfizer and Baxter show stable financial trajectories, with Baxter’s recent launch contributing to its revenue growth.

FAQs

What is the expected market size of the penicillin drug market in 2024?

The penicillin drug market is expected to reach USD 10.71 billion in 2024[3].

Which region is the fastest-growing in the penicillin drug market?

The Asia-Pacific region is expected to grow at the highest CAGR over the forecast period[3].

What are the key benefits of the ZOSYN premix formulation?

The ZOSYN premix formulation simplifies medication preparation, reduces the risk of contamination and dosing errors, and improves operational efficiencies for healthcare providers[4].

Who are the major players in the penicillin drug market?

Major players include Pfizer Inc., Novartis AG, GSK plc, Lupin Limited, and Sanofi SA[3].

How does antimicrobial resistance impact the penicillin drug market?

Antimicrobial resistance is a significant challenge that could restrain market growth by reducing the effectiveness of existing antibiotics and necessitating the development of new treatments[3].

Cited Sources

1. Pfizer: ZOSYN® (Piperacillin and Tazobactam for Injection, USP) - Pfizer
2. Pfizer: Pfizer Reports Fourth-Quarter and Full-Year 2013 Results
3. Mordor Intelligence: Penicillin Drug Market Report | Industry Analysis, Size & Forecast
4. Baxter: Baxter Launches Zosyn Premix In US
5. Baxter: Baxter Reports Fourth-Quarter and Full-Year 2023 Results