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Last Updated: December 16, 2025

PENICILLIN-VK Drug Patent Profile


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Which patents cover Penicillin-vk, and what generic alternatives are available?

Penicillin-vk is a drug marketed by Teva and is included in two NDAs.

The generic ingredient in PENICILLIN-VK is penicillin v potassium. There are ninety-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the penicillin v potassium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Penicillin-vk

A generic version of PENICILLIN-VK was approved as penicillin v potassium by CHARTWELL RX on November 23rd, 1988.

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Summary for PENICILLIN-VK
Drug patent expirations by year for PENICILLIN-VK
Recent Clinical Trials for PENICILLIN-VK

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SponsorPhase
Centre Hospitalier Universitaire DijonPHASE3
Rehman Medical Institute - RMIPHASE4
University of California, Los AngelesPHASE2

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Pharmacology for PENICILLIN-VK

US Patents and Regulatory Information for PENICILLIN-VK

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva PENICILLIN-VK penicillin v potassium FOR SOLUTION;ORAL 060456-001 Approved Prior to Jan 1, 1982 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva PENICILLIN-VK penicillin v potassium TABLET;ORAL 060711-003 Approved Prior to Jan 1, 1982 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva PENICILLIN-VK penicillin v potassium FOR SOLUTION;ORAL 060456-002 Approved Prior to Jan 1, 1982 RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva PENICILLIN-VK penicillin v potassium TABLET;ORAL 060711-002 Approved Prior to Jan 1, 1982 AB RX 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 PENICILLIN VK

Last updated: August 2, 2025

Introduction

Penicillin VK, also known as phenoxymethylpenicillin, remains one of the most enduring antibiotics in clinical use since its discovery in 1928. Its significance stems from a broad spectrum of activity against gram-positive bacteria, including streptococci, pneumococci, and staphylococci, making it a cornerstone in the treatment of bacterial infections. Despite advances in antimicrobial therapies, Penicillin VK continues to occupy a vital niche in global healthcare, influencing market dynamics and shaping its financial trajectory.

Medical and Commercial Relevance

Penicillin VK is favored for its oral administration and favorable safety profile compared to other antibiotics. Its widespread use in outpatient settings for diseases such as pharyngitis, skin infections, and dental prophylaxis supports its consistent demand. According to the World Health Organization (WHO), penicillin remains one of the most utilized antibiotics globally, with Penicillin VK leading in specific regions, especially in countries with well-established healthcare systems.

Market penetration hinges on its affordability, availability, and regulatory endorsement. Generic manufacturing dominates, with several pharmaceutical companies worldwide producing Penicillin VK under various brand names, significantly contributing to its market stability.

Market Dynamics

  1. Global Demand and Usage Trends

    The demand for Penicillin VK is driven predominantly by its role in primary healthcare. In developed markets like North America and Europe, its usage is often constrained by antimicrobial resistance concerns and evolving guidelines favoring narrower-spectrum antibiotics. Nevertheless, in emerging economies, the drug retains central importance due to its low cost and effectiveness.

    With a growing global population and expanding healthcare access, the overall demand remains steady, especially in regions with limited antimicrobial stewardship programs. Additionally, the resurgence of bacterial infections during outbreaks or pandemics — such as COVID-19 — has temporarily increased the stewardship for antibiotics like Penicillin VK.

  2. Pricing and Regulatory Factors

    Being a generic drug, Penicillin VK's pricing is relatively low, contributing to consistent sales, particularly in low-to-middle-income countries. The absence of patent restrictions allows multiple manufacturers to supply the market, ensuring an affordable supply chain and preventing monopolistic price hikes.

    Regulatory approvals for new formulations or indications are infrequent but essential for maintaining market access. Regulatory agencies' policies on antimicrobial resistance and stewardship influence prescribing practices and, consequently, market size.

  3. Competition and Alternative Therapies

    While Penicillin VK remains a staple antibiotic, competition arises from other classes such as cephalosporins and macrolides, which may offer broader coverage or alternative administration routes. However, due to cost-effectiveness and established efficacy, Penicillin VK maintains a loyal market segment, especially for uncomplicated infections.

  4. Impact of Antimicrobial Resistance (AMR)

    The rise of resistant bacterial strains, such as penicillin-resistant pneumococci and staphylococci, threatens Penicillin VK's effectiveness. Resistance patterns vary geographically, impacting prescribing habits and market sales. Efforts to contain AMR include stewardship programs that promote judicious use, which, paradoxically, curtail overuse but may also limit sales in resistant strains' prevalence areas.

  5. Innovation and Formulation Development

    Limited innovation surrounds Penicillin VK due to the maturity of the product, but ongoing efforts focus on new formulations and combination therapies to enhance efficacy and compliance. These developments influence market longevity and financial prospects modestly.

Financial Trajectory

  1. Market Size and Revenue Estimates

    Global sales of Penicillin VK are estimated to be in the hundreds of millions of dollars annually, primarily driven by emerging markets and hospital procurement contracts. The high penetration in low-cost producing countries ensures a baseline revenue stream that remains relatively stable despite cautious prescribing trends.

  2. Profitability and Cost Dynamics

    The manufacturing cost for Penicillin VK remains low due to established fermentation and synthesis processes. The product’s generic nature ensures competitive pricing, pressure on margins but guarantees volume-driven revenue. Manufacturers benefit from economies of scale, maintaining profitability despite thin profit margins.

  3. Market Expansion and Growth Opportunities

    Future growth avenues include expanding access in underserved regions, increasing use in outpatient settings, and integrating Penicillin VK into combination therapies for resistant infections. However, growth is constrained by antimicrobial stewardship policies and resistance-driven shifts toward alternative antibiotics.

  4. Regulatory and Patent Landscape

    The expiration of patents has democratized manufacturing but also stagnated innovation, contributing to a predictable revenue stream for generic producers. Regulatory support in emerging markets accelerates acceptance, reinforcing a steady financial trajectory.

  5. Impact of Healthcare Policy and Global Initiatives

    International efforts to combat antimicrobial resistance, such as WHO’s Global Action Plan, influence prescribing patterns. While promoting prudent use, these initiatives stabilize the demand within acceptable limits. Moreover, governmental procurement policies often prioritize low-cost drugs like Penicillin VK.

Conclusion

The market for Penicillin VK is characterized by stability driven by its entrenched position in global healthcare, affordability, and ongoing demand in less affluent regions. Despite challenges posed by antimicrobial resistance and evolving therapeutic standards, its low manufacturing costs and broad acceptance ensure a consistent financial trajectory. Strategic focus on expanding access, optimizing formulations, and supporting stewardship alongside global health policies will be key to safeguarding its market position.


Key Takeaways

  • Penicillin VK remains a foundational antibiotic with stable global demand, especially in emerging markets.
  • Its generic status sustains low pricing, ensuring affordability but exerting pressure on profit margins.
  • Resistance development presents significant challenges, prompting cautious prescribing and stewardship programs.
  • Limited innovation underscores reliance on existing formulations, though minor development opportunities persist.
  • Global health initiatives and regulatory policies significantly shape its market dynamics and financial prospects.

FAQs

1. How does antimicrobial resistance impact the market for Penicillin VK?
Resistance diminishes efficacy in certain bacterial strains, leading to decreased prescribing in resistant regions. This trend reduces overall sales volume but drives demand for alternative antibiotics, influencing the drug’s market share.

2. What are the primary markets for Penicillin VK globally?
Developed countries utilize Penicillin VK mainly for uncomplicated infections, with restrictions due to resistance concerns. Emerging economies account for significant consumption owing to affordability and widespread use in outpatient care.

3. Are there recent innovations or new formulations of Penicillin VK?
Innovation remains limited to minor formulation improvements and combination therapies. The product’s mature status restricts substantial new developments, focusing instead on maintaining existing formulations.

4. How does government policy influence Penicillin VK's market trajectory?
Policies promoting antimicrobial stewardship and resistance mitigation generally limit over-prescription. Conversely, procurement policies in low-income countries support continued baseline sales driven by cost-effectiveness.

5. What are the long-term prospects of Penicillin VK in the global pharmaceutical landscape?
While facing challenges from resistance and newer antibiotics, Penicillin VK’s low-cost, broad applicability ensures its persistence, especially in resource-limited settings. Its market stability depends on balancing stewardship with access and minor innovations aligning with global health priorities.


Sources
[1] World Health Organization, "Antibiotic Resistance."
[2] IMS Health, "Global Antibiotic Market Report."
[3] Centers for Disease Control and Prevention, "Antimicrobial Resistance Data."
[4] GlobalData, "Pharmaceutical Market Analysis," 2023.
[5] FDA, "Generic Drug Approvals and Market Data."

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