Last Updated: May 3, 2026

piperacillin sodium; tazobactam sodium - Profile


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What are the generic sources for piperacillin sodium; tazobactam sodium and what is the scope of patent protection?

Piperacillin sodium; tazobactam sodium is the generic ingredient in four branded drugs marketed by Apotex, Astral, Eugia Pharma, Eugia Pharma Speclts, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Milla Pharms, Onesource Specialty, Sagent Pharms Inc, Sandoz, Shandong, Wyeth Pharms, Baxter Hlthcare Corp, and B Braun Medical, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

Summary for piperacillin sodium; tazobactam sodium
US Patents:0
Tradenames:4
Applicants:16
NDAs:25
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
Apotex PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 206996-001 Mar 22, 2017 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apotex PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 206996-002 Mar 22, 2017 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apotex PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 206996-003 Mar 22, 2017 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apotex PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 207146-001 Mar 17, 2017 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Astral PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 212287-001 Jul 29, 2019 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Astral PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 212287-002 Jul 29, 2019 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Astral PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 212287-003 Jul 29, 2019 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for piperacillin sodium; tazobactam sodium

Investment Scenario and Fundamentals Analysis for Piperacillin Sodium; Tazobactam Sodium

Last updated: February 20, 2026

What is the current market landscape for piperacillin sodium; tazobactam sodium?

Piperacillin sodium; tazobactam sodium is a broad-spectrum antibiotic combination used to treat complicated infections. It is marketed under various brand names such as Zosyn (Pfizer). The drug targets hospital-acquired infections, sepsis, and intra-abdominal infections. The global antibiotic market exceeds USD 60 billion in 2022, with piperacillin-tazobactam accounting for a significant portion due to its clinical utility [1].

How do the drug’s clinical and regulatory fundamentals support investment?

Patent and Regulatory Status

  • The original patent for Zosyn expired in 2014 in the U.S., prompting generic competition.
  • Several generics approved in major markets, including the U.S., Europe, and Japan.
  • New formulations, such as extended infusion versions, are under development or regulatory review to improve efficacy and reduce resistance.

Manufacturing and Supply Chain

  • Production relies on established large-scale fermentation and chemical synthesis.
  • Supply dependency on key active pharmaceutical ingredients (API) suppliers, primarily in Asia.
  • Quality and compliance with Good Manufacturing Practices (GMP) are well established among major manufacturers.

Clinical Development and Off-Label Uses

  • Ongoing research into resistant bacterial strains, including Acinetobacter baumannii and multidrug-resistant Pseudomonas aeruginosa.
  • Potential expansion into outpatient settings with alternative formulations.
  • No significant pipeline delays reported; the drug's role as a standard-of-care antibiotic maintains steady demand.

What are the current market dynamics influencing investment?

Competitive Landscape

Competitors Market Share (Approx.) Key Features
Generic manufacturers 60% Cost-effective, high volume
Innovative formulations 20% Extended infusion, stability improvements
Brand (Pfizer Zosyn) 20% Higher price, brand recognition
  • Generics dominate due to patent expiration; however, branded versions maintain premium pricing.
  • The development of novel formulations may extend market exclusivity temporarily.

Pricing Trends

  • Average price for a 3.375 g dose varies by region but has stabilized post-patent expiration.
  • Market incentives favor high-volume sales, especially in hospital settings.
  • Price erosion expected from increasing generics may squeeze margins but sustain volume-driven growth.

Resistance Challenges

  • Rising antibiotic resistance in healthcare settings pressures demand for new or combination therapies.
  • Surveillance programs increase compliance costs but also reinforce the need for effective antibiotics like piperacillin-tazobactam.
  • Investment in resistance mitigation programs can extend product lifecycle.

Regulatory Environment

  • Approved in 100+ countries, with ongoing regulatory reviews for new formulations.
  • Reimbursement policies favor hospital-administered antibiotics.
  • Stringent antimicrobial stewardship programs potentially limit overuse but enhance targeted application, supporting sustained demand.

What are the key financial metrics and growth drivers?

  • Market Size: Estimated to reach USD 5.2 billion globally by 2028.
  • Growth Rate: CAGR of 4% in the antibiotic segment, with piperacillin-tazobactam growing proportionally.
  • Profitability: Revenue mainly from generic sales, with gross margins around 50% due to manufacturing efficiencies.
  • Research & Development: Moderate investment; pipeline products include combination therapies targeting resistant strains.

What are the investment risks and opportunities?

Risks

  • Potential decline in demand due to emerging resistance to piperacillin-tazobactam.
  • Price erosion from increased generic competition.
  • Regulatory hurdles for new formulations or indications.

Opportunities

  • Expanding indications in outpatient and low-resource settings.
  • Development of fixed-dose combination therapies to combat resistance.
  • Geographic expansion into emerging markets with growing hospital infrastructure.

Closing summary

Piperacillin sodium; tazobactam sodium presents a stable investment profile driven by its entrenched position in hospital care, consistent demand, and ongoing development of improved formulations. Risks relate mainly to resistance and price competition; however, these are counterbalanced by expanding markets and strategic product differentiation.

Key Takeaways

  • The drug remains a cornerstone antibiotic with stable global sales.
  • Patent expirations have led to a high presence of generics, exerting downward pressure on prices.
  • New formulations and combination therapies offer growth avenues.
  • Resistance trends necessitate ongoing R&D to sustain efficacy.
  • Market expansion opportunities exist in emerging markets and outpatient settings.

FAQs

1. What is the lifecycle stage of piperacillin-tazobactam?
It is in the mature phase with high generic penetration and incremental innovation primarily through formulation improvements.

2. Are new patent protections expected?
No significant new patents are anticipated on the core molecule; focus shifts to formulations and new indications.

3. How does resistance impact future sales?
Increasing resistance could reduce efficacy, leading to declining sales unless new combinations or formulations are introduced.

4. What markets are the most lucrative for expansion?
Emerging markets with expanding hospital infrastructure and limited existing antibiotic options offer growth potential.

5. How does antimicrobial stewardship influence this drug’s market?
Stewardship programs limit overuse, but piperacillin-tazobactam remains essential for specific infections, supporting consistent demand.


References

  1. Statista. (2022). Global antibiotic market size. https://www.statista.com
  2. Pfizer. (2020). Zosyn (piperacillin-tazobactam) prescribing information.
  3. IQVIA. (2022). Global pharmaceutical market analysis.
  4. World Health Organization. (2021). Antimicrobial resistance global report.

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