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Last Updated: December 13, 2025

POLYCILLIN Drug Patent Profile


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Which patents cover Polycillin, and when can generic versions of Polycillin launch?

Polycillin is a drug marketed by Bristol and Apothecon and is included in seven NDAs.

The generic ingredient in POLYCILLIN is ampicillin/ampicillin trihydrate; probenecid. Additional details are available on the ampicillin/ampicillin trihydrate; probenecid profile page.

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Summary for POLYCILLIN
US Patents:0
Applicants:2
NDAs:7
Raw Ingredient (Bulk) Api Vendors: 76
DailyMed Link:POLYCILLIN at DailyMed
Drug patent expirations by year for POLYCILLIN

US Patents and Regulatory Information for POLYCILLIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol POLYCILLIN ampicillin/ampicillin trihydrate CAPSULE;ORAL 050310-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bristol POLYCILLIN ampicillin/ampicillin trihydrate FOR SUSPENSION;ORAL 050308-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Apothecon POLYCILLIN ampicillin/ampicillin trihydrate FOR SUSPENSION;ORAL 062297-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bristol POLYCILLIN-N ampicillin sodium INJECTABLE;INJECTION 050309-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bristol POLYCILLIN ampicillin/ampicillin trihydrate FOR SUSPENSION;ORAL 050308-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bristol POLYCILLIN-PRB ampicillin/ampicillin trihydrate; probenecid FOR SUSPENSION;ORAL 050457-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bristol POLYCILLIN-N ampicillin sodium INJECTABLE;INJECTION 050309-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for POLYCILLIN

Last updated: July 27, 2025


Introduction

POLYCILLIN, a broad-spectrum antibiotic derived from penicillin derivatives, has historically maintained a significant role in the antimicrobial landscape. As antibiotic resistance increases and emerging markets expand, understanding its market dynamics and financial trajectory becomes vital for stakeholders, including manufacturers, investors, and healthcare policymakers. This analysis explores the current market landscape, key growth drivers, challenges, and future forecasts for POLYCILLIN.


Market Overview

POLYCILLIN's market presence spans over six decades, primarily in bacterial infection treatments such as pneumonia, streptococcal pharyngitis, and skin infections. Despite the advent of newer antibiotics, POLYCILLIN retains relevance due to its efficacy, cost-effectiveness, and regulatory approval in multiple jurisdictions. The global antibiotics market was valued at approximately USD 44.5 billion in 2021 and is projected to reach USD 57.7 billion by 2027, growing at a CAGR of 4.4% [1]. Within this landscape, POLYCILLIN occupies a niche, especially in developing economies where affordable off-patent drugs have sustained demand.

Key Market Drivers

1. Antibiotic Resistance and Re-Emphasis on Established Drugs

Rising antimicrobial resistance (AMR) threatens the efficacy of newer drugs, prompting renewed interest in older, well-understood antibiotics. POLYCILLIN, with its established safety profile, is increasingly employed as a first-line treatment in regions where resistance profiles favor its use [2].

2. Expanding Rural and Developing Markets

Emerging economies such as India, China, and parts of Africa see sustained demand due to high prevalence of bacterial infections, limited healthcare infrastructure, and cost sensitivity. These markets favor established, low-cost antibiotics like POLYCILLIN, bolstered by government campaigns to enhance antibiotic access.

3. Generics and Cost-Effectiveness

Generic manufacturing sustains POLYCILLIN’s low-price advantage. Market entry barriers are low due to the drug's patent expiration, leading to widespread production and distribution, which further stabilizes supply and pricing.

4. Regulatory Approvals and Adaptations

Various regulatory bodies have approved formulations of POLYCILLIN for pediatric and adult indications. Additionally, modifications such as extended-release versions and combination formulations retain clinical relevance.

Market Challenges

1. Antimicrobial Stewardship and Regulatory Constraints

Global efforts to combat AMR advocate for cautious antibiotic use, restricting prescriptions of broad-spectrum agents like POLYCILLIN. Regulatory bodies advocate stewardship programs that limit unnecessary or inappropriate usage, potentially constraining demand [3].

2. Competition from Modern Antibiotics

Newer antibiotics with enhanced pharmacokinetics and narrower spectra are progressively replacing traditional drugs. For example, third-generation cephalosporins and carbapenems are preferred in certain resistant infections, challenging POLYCILLIN’s market share.

3. Safety and Resistance Concerns

Overuse of POLYCILLIN contributes to resistance development. Increasing awareness and surveillance reports warn against indiscriminate use, impacting prescriptions and long-term profitability.

Financial Trajectory Analysis

Current Revenue and Market Share

While specific revenue figures for POLYCILLIN are proprietary and vary by region, its sales are estimated to be in the low hundreds of millions USD globally, predominantly volume-driven. Its market share within the antibiotic class remains significant in developing countries but diminishes in high-income markets dominated by newer agents.

Forecasted Growth Opportunities

  • Emerging Markets: Expected to see a compound annual growth rate (CAGR) of approximately 3-4% over the next five years, driven by healthcare expansion initiatives.
  • Product Line Extensions: Development of fixed-dose combination therapies and novel formulations could provide incremental revenue streams.
  • Generic Competition Dynamics: Price erosion is inevitable; however, volume sales in underserved regions can sustain revenue levels.

Risks and Limiting Factors

  • Regulatory hurdles in certain countries may restrict market access.
  • Antimicrobial stewardship policies could further limit prescription volumes.
  • Market saturation in mature regions reduces growth prospects.

Future Outlook and Strategic Considerations

The outlook for POLYCILLIN remains cautiously optimistic. Stakeholders should focus on strengthening supply chains, engaging in stewardship programs, and innovating formulation strategies to maintain its relevance. Additionally, collaborations with governments for inclusion in essential medicines lists can bolster market penetration.

Investment in post-marketing surveillance and resistance monitoring can inform appropriate use, mitigating resistance development and safeguarding its long-term financial viability.


Key Takeaways

  • Market Position: POLYCILLIN remains a cost-effective treatment option especially in emerging economies, but faces challenges from newer antibiotics and stewardship policies.
  • Growth Drivers: Demand for affordable antibiotics, expanding healthcare access in developing nations, and its established safety profile support its ongoing relevance.
  • Challenges: Rising antimicrobial resistance, regulatory restrictions, and competition from advanced antibiotics threaten revenue stability.
  • Financial Strategy: Focusing on strategic markets, innovative formulations, and aligning with global stewardship initiatives can help sustain profitability.
  • Long-term Outlook: Stable but moderate growth is expected, contingent on effective stewardship, regulatory adaptations, and global health trends.

FAQs

Q1. How does antimicrobial resistance impact POLYCILLIN's market viability?
Rising resistance diminishes the clinical effectiveness of POLYCILLIN, prompting prescribers to seek alternative therapies. While resistance may temporarily constrain growth, strategic use in appropriate indications can sustain demand, especially where resistance remains low.

Q2. Which regions are the primary growth markets for POLYCILLIN?
Developing countries in Asia, Africa, and Latin America represent the most promising markets due to high infection burdens, cost sensitivity, and ongoing healthcare infrastructure development.

Q3. What role do generic manufacturers play in POLYCILLIN’s financial trajectory?
Generics drive affordability and volume sales, maintaining POLYCILLIN's market presence. However, this also leads to price erosion, necessitating cost-efficient manufacturing and distribution strategies.

Q4. How do global antimicrobial stewardship policies influence POLYCILLIN's future?
Stewardship programs aim to reduce inappropriate antibiotic use, potentially limiting prescription volumes of broad-spectrum drugs like POLYCILLIN. However, well-implemented policies can ensure sustainable demand by emphasizing appropriate use.

Q5. Are there ongoing innovations or reformulations of POLYCILLIN?
Yes. Efforts include developing combination formulations, extended-release versions, and optimizing dosing regimens to improve efficacy and compliance, thus supporting its market viability.


References

[1] MarketsandMarkets. "Antibiotics Market by Product, Route of Administration, Distribution Channel, and Region." 2021.
[2] World Health Organization. "Global Action Plan on Antimicrobial Resistance." 2015.
[3] Centers for Disease Control and Prevention. "Antibiotic Stewardship: Principles and Practice." 2020.

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