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ZOSYN IN PLASTIC CONTAINER Drug Patent Profile

When do Zosyn In Plastic Container patents expire, and what generic alternatives are available?

Zosyn In Plastic Container is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.

The generic ingredient in ZOSYN IN PLASTIC CONTAINER 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 IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	6
Patent Applications:	1
DailyMed Link:	ZOSYN IN PLASTIC CONTAINER at DailyMed

Pharmacology for ZOSYN IN PLASTIC CONTAINER

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

US Patents and Regulatory Information for ZOSYN IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-003	Feb 24, 1998		RX	Yes	Yes
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998		RX	Yes	Yes
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-002	Feb 24, 1998		RX	Yes	Yes

Expired US Patents for ZOSYN IN PLASTIC CONTAINER

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	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	6,207,661
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-003	Feb 24, 1998	6,207,661
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998	7,915,229
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-002	Feb 24, 1998	7,915,229
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998	6,900,184

International Patents for ZOSYN IN PLASTIC CONTAINER

See the table below for patents covering ZOSYN IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0050035
Taiwan	200503758	Compositions containing piperacillin and tazobactam useful for injection
South Africa	200508315	Compositions containing piperacillin and tazobactam useful for injection
Portugal	1154770
Brazil	PI0409450	composições que contêm peperacilina e tazobactamo, úteis para injeção
Japan	4820244
France	2853547	COMPOSITIONS PHARMACEUTIQUES INJECTABLES CONTENANT DE LA PIPERACILLINE ET DU TAZOBACTAME, ET PROCEDE POUR LEUR PRODUCTION

ZOSYN IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZOSYN in Plastic Containers

Overview of ZOSYN

ZOSYN, a combination of the antibiotic piperacillin and the β-lactamase inhibitor tazobactam, is a widely used antibacterial drug. It is available in various formulations, including a premixed frozen solution in Galaxy plastic containers[3].

Market Position and Sales

ZOSYN is one of the top-selling antibiotics in the U.S. market. According to recent sales data, ZOSYN generated approximately $256.6 million in annual revenue in 2022, making it the leading branded antibiotic in terms of sales[5].

Competitive Landscape

The antibiotic market is dominated by generic, off-patent products, which account for the majority of antibiotic volume. However, branded antibiotics like ZOSYN maintain significant market share due to their efficacy and the trust associated with well-established brands. ZOSYN competes with other branded antibiotics such as Avycaz and Teflaro, but its unique formulation and broad-spectrum activity help it retain a strong market position[5].

Financial Performance

Revenue and Market Share

ZOSYN's annual revenue of $256.6 million places it at the top of the antibiotic sales charts. This revenue is a testament to the drug's effectiveness and its widespread use in treating bacterial infections. The drug's market share is stable, despite the dominance of generics in the broader antibiotic market[5].

Cost of Production and Pricing

The production costs of ZOSYN include the costs of the active ingredients (piperacillin and tazobactam), the manufacturing process, and the unique Galaxy plastic container. The pricing strategy for ZOSYN is influenced by its clinical benefit, market demand, and competition from generic alternatives. The drug's pricing helps maintain a balance between profitability and accessibility for patients[3].

Funding and Investment Models

Traditional Funding Models

The development and commercialization of antibiotics like ZOSYN typically involve significant investment. Traditional funding models include equity financing and debt financing. However, these models have faced challenges in recent years due to macroeconomic factors and the high risks associated with drug development[2].

Royalty Financing

Royalty financing has emerged as a growing alternative to traditional funding models. This approach involves selling royalty rights on drug sales to investors. For example, deals like the one between Royalty Pharma and Epizyme, where royalty rights on tazemetostat were purchased for up to $570 million, illustrate the increasing popularity of this model. Such financing can help biopharma companies fund late-stage development and early commercialization of their products, including antibiotics like ZOSYN[2].

Net Present Value (NPV) and Financial Projections

NPV Models

Evaluating the financial trajectory of a drug like ZOSYN involves complex NPV models. These models consider cash inflows and outflows, success rates at each stage of development, and future market projections. For antibiotics, the NPV is often influenced by factors such as the drug's comparative clinical benefit, market size, and competition from generics[1].

Return on Investment (ROI)

The ROI for antibiotics can be modest compared to other therapeutic areas. However, an internal rate of return (IRR) target of 11% is often considered sufficient to incentivize private sector investment in novel antibiotic development. This target exceeds the weighted average cost of capital in the pharmaceutical industry and aligns with long-term performance benchmarks for venture capital[5].

Clinical Benefit and Market Reward

Comparative Clinical Benefit

Drugs with higher comparative clinical benefit scores tend to have higher early market sales. For antibiotics like ZOSYN, the clinical benefit is a key driver of market success. The drug's ability to treat a wide range of bacterial infections effectively contributes to its strong market performance[4].

Market Reward

The market rewards drugs with significant clinical benefits. For example, oncology drugs with high comparative clinical benefit scores have exponentially higher sales compared to other therapeutic areas. While antibiotics may not achieve the same level of sales as oncology drugs, those with strong clinical profiles, like ZOSYN, are rewarded with substantial market share and revenue[4].

Challenges and Opportunities

Antibiotic Resistance

One of the significant challenges facing antibiotics is the growing issue of antibiotic resistance. This can impact the long-term financial trajectory of drugs like ZOSYN by reducing their effectiveness and necessitating the development of new antibiotics[5].

Regulatory Incentives

Regulatory incentives, such as pull incentives, can play a crucial role in encouraging the development of new antibiotics. These incentives can help offset the high costs and risks associated with antibiotic development, making it more financially viable for companies to invest in this area[5].

Future Outlook

Market Growth

The market for antibiotics is expected to continue growing, driven by increasing demand for effective treatments for bacterial infections. ZOSYN, with its established market presence and clinical efficacy, is well-positioned to benefit from this growth[5].

Innovative Formulations

The use of innovative formulations, such as the Galaxy plastic container, can enhance the market appeal of ZOSYN. These formulations can improve patient compliance and reduce healthcare costs, contributing to the drug's financial success[3].

Key Takeaways

• Market Position: ZOSYN is a top-selling antibiotic with significant market share.
• Financial Performance: The drug generates substantial revenue, with an annual figure of $256.6 million.
• Funding Models: Royalty financing is becoming a popular alternative to traditional funding models for biopharma companies.
• NPV and ROI: NPV models and an IRR target of 11% are crucial for evaluating and incentivizing investment in antibiotic development.
• Clinical Benefit: The drug's strong clinical profile drives its market success.
• Challenges and Opportunities: Antibiotic resistance and regulatory incentives are key factors influencing the financial trajectory of ZOSYN.

FAQs

Q: What is the annual revenue of ZOSYN in the U.S. market? A: ZOSYN generated approximately $256.6 million in annual revenue in 2022[5].

Q: How does royalty financing impact the development of antibiotics like ZOSYN? A: Royalty financing provides an alternative funding source for biopharma companies, helping to fund late-stage development and early commercialization of antibiotics[2].

Q: What is the significance of the Galaxy plastic container for ZOSYN? A: The Galaxy plastic container is a unique formulation that enhances patient compliance and reduces healthcare costs, contributing to the drug's market appeal[3].

Q: How does antibiotic resistance affect the financial trajectory of ZOSYN? A: Antibiotic resistance can reduce the effectiveness of ZOSYN, impacting its long-term financial performance and necessitating the development of new antibiotics[5].

Q: What is the preferred IRR target for investing in novel antibiotic development? A: An IRR target of 11% is often considered sufficient to incentivize private sector investment in novel antibiotic development, exceeding the weighted average cost of capital in the pharmaceutical industry[5].

Sources

1. GlobalData: Net Present Value Model: Zosyn/Tazocin - GlobalData
2. ZS: A growing alternative to traditional biopharma fundraising - ZS
3. Pfizer: ZOSYN®(Piperacillin and Tazobactam Injection) in Galaxy® Containers (PL 2040 Plastic)
4. ASPE: Antimicrobial Drugs Market Returns Analysis
5. Harvard Kennedy School: Sizing A Market Entry Reward for the Development of New Antibiotics