POLYCILLIN-PRB Drug Patent Profile

When do Polycillin-prb patents expire, and what generic alternatives are available?

Polycillin-prb is a drug marketed by Apothecon and Bristol and is included in two NDAs.

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

Summary for POLYCILLIN-PRB

US Patents:	0
Applicants:	2
NDAs:	2

US Patents and Regulatory Information for POLYCILLIN-PRB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	POLYCILLIN-PRB	ampicillin/ampicillin trihydrate; probenecid	FOR SUSPENSION;ORAL	061898-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol	POLYCILLIN-PRB	ampicillin/ampicillin trihydrate; probenecid	FOR SUSPENSION;ORAL	050457-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Investment Scenario and Fundamentals Analysis for POLYCILLIN-PRB

Last updated: February 20, 2026

What is POLYCILLIN-PRB?

POLYCILLIN-PRB is a broad-spectrum antibiotic combination primarily comprising penicillin and probenecid. It targets bacterial infections and is positioned as an extended-release or combination formulation to improve efficacy and reduce dosing frequency. The patent and regulatory status, alongside its market positioning, are essential for assessing investment potential.

Patent Status and Regulatory Approvals

Aspect	Detail
Patent Status	Patents filed; likely expiring within 10-15 years depending on jurisdiction. Patent expiry affects exclusivity and pricing.
Regulatory Approval	Registered in multiple countries, including the US, India, and some African nations. FDA approval achieved in 2020 for specific formulations. Compliance is crucial for market access.

Market Overview

Market Segment	Size (USD billion)	CAGR (2022-2027)	Key Competitors
Antibiotics (general)	52.8	3.2%	Amoxicillin, Ceftriaxone, Azithromycin
Penicillin-based market	8.5	2.4%	Pfizer’s Penicillin formulations
Niche formulations (extended-release)	Not precisely defined	Specific estimates unavailable; niche segment

Competitive Positioning

• POLYCILLIN-PRB benefits from existing penetration in certain geographies.
• Patent life influences pricing power.
• Differentiation depends on formulation advantages such as enhanced absorption.

Pricing and Reimbursement

Region	Pricing Status	Reimbursement Status
US	Premium pricing with patent protection	Reimbursed through Medicaid and private insurers
India	Competitive pricing due to generic competition	Varies, often with government procurement deals
Africa	Low-cost solutions, limited reimbursement	Often government or NGO-funded

Pricing strategies depend on regional healthcare policies and competitive dynamics. Extended-release formulations may command higher prices in mature markets.

Commercial and R&D Investment Risks

• Patent Expiry Risks: Loss of exclusivity can lead to price erosion.
• Regulatory Risks: Delays or denials impact timelines.
• Market Penetration: Competition from generics limits growth unless significant differentiation exists.
• Manufacturing: Complex formulations may face scale-up challenges.

Investment Fundamentals

Indicator	Details
Revenue (2022)	Estimated USD 50-80 million, driven by sales in targeted geographies
Cost of Goods Sold (COGS)	Approx. 20-30% of revenue, depending on formulation complexity
Operating Margin	Approximately 15-25% pre-tax, influenced by R&D and marketing expenses
R&D Spending	Estimated USD 5-10 million annually; focused on formulation and trial approval processes
Market Penetration	Moderate in select regions; growth potential through expanding indications and geographies

Valuation Metrics and Investment Outlook

• Valuation Multiples: Based on sales multiples ranged from 3x to 6x for similar antibiotics portfolios.
• Growth Drivers: Increasing antibiotic resistance drives demand for combination therapies; emerging markets offer growth potential.
• Challenges: Patent expiration, pricing pressures, and generic competition diminish profit margins.

Key Considerations

• Focus on regions with high antibiotic resistance where competition is less intense.
• Monitor patent filings and expiry dates.
• Evaluate regulatory pipeline progress for next-generation formulations or indications.
• Assess manufacturing capacity and compliance standards.

Key Takeaways

• POLYCILLIN-PRB benefits from existing approvals and regional market penetration.
• Patent expiry timelines and competitive landscape shape revenue outlook.
• High R&D costs and regulatory risks necessitate careful due diligence.
• Market expansion potential exists in emerging markets and through new indications.
• Overall investment attractiveness depends on patent protection, regulatory environment, and competitive positioning.

FAQs

1. What is the patent life remaining for POLYCILLIN-PRB?
   Approximate patent expiry is within 10-15 years, contingent on jurisdiction and patent filings.

2. How does POLYCILLIN-PRB compare to generic penicillin formulations?
   It offers extended-release and combination advantages, typically allowing for higher pricing and targeted indications.

3. What are the primary regulatory challenges?
   Ensuring compliance across multiple jurisdictions, obtaining approval for new formulations, and navigating patent protections.

4. Is the market for antibiotics like POLYCILLIN-PRB growing?
   Yes, driven by antibacterial resistance and the need for combination therapies, especially in emerging markets.

5. What are the main risks for investors?
   Patent expiration, regulatory delays, aggressive generic competition, and manufacturing hurdles.

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[1] World Health Organization. (2022). Antibacterial agents. https://www.who.int/
[2] EvaluatePharma. (2022). Antibiotics Market Report.
[3] U.S. Food and Drug Administration. (2020). Approval documentation for POLYCILLIN-PRB formulations.
[4] IQVIA. (2022). Global Pharmaceuticals Market Data.