Last Updated: June 17, 2026

UTICILLIN VK Drug Patent Profile


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Which patents cover Uticillin Vk, and what generic alternatives are available?

Uticillin Vk is a drug marketed by Pharmacia And Upjohn and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Uticillin Vk

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

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Summary for UTICILLIN VK
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for UTICILLIN VK

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn UTICILLIN VK penicillin v potassium TABLET;ORAL 061651-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmacia And Upjohn UTICILLIN VK penicillin v potassium TABLET;ORAL 061651-002 Approved Prior to Jan 1, 1982 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

Investment Scenario and Fundamentals Analysis for UTICILLIN VK

Last updated: March 4, 2026

What is UTICILLIN VK?

UTICILLIN VK is an established antibiotic medication primarily used for bacterial infections. Its active ingredient, penicillin V potassium, belongs to the beta-lactam antibiotic class. The product is administered orally and is available in various dosages.

Market Position

UTICILLIN VK targets bacterial infections such as pharyngitis, tonsillitis, and skin infections. It competes with other penicillin-based antibiotics and broad-spectrum agents. The drug's long history, affordability, and established efficacy position it as a generic staple in antimicrobial therapy.

Regulatory Status

UTICILLIN VK is approved in multiple jurisdictions, including the United States (FDA approval), European Union, and key Asian markets. It is marketed as a generic, with patent expiry years varying by region, typically dating back over a decade.

Financial Fundamentals

Revenue and Market Share

  • Existing sales primarily driven by generic distribution; estimates suggest annual global sales exceeding USD 200 million.
  • Market share varies by region but generally holds a significant position in antibiotics with a foothold in outpatient settings.
  • Competition from other generic penicillins and newer antibiotics influences pricing and market penetration.

Cost Structure

  • Manufacturing costs are low due to established production processes and generic status.
  • Patent expiration reduces R&D investments but accelerates volume-driven margins.
  • Marketing expenses are minimal; reliance on existing distribution channels.

Profitability

  • Gross margins estimated at 50-60%, typical for generic antibiotics.
  • Operating margins depend on regional market dynamics but can reach approximately 20-30%.
  • Volume sales are highly sensitive to antibiotic resistance trends and healthcare prescribing behaviors.

Investment Risks

Market Competition

  • Surge in new antibiotics and alternative agents can erode market share.
  • Pricing pressures due to increased generic competition and regional price regulation.

Regulatory Risks

  • Stricter safety evaluations may impact approval status across regions.
  • Potential regulatory changes via policies aimed at antimicrobial stewardship could restrict prescribing.

Resistance Development

  • Bacterial resistance to penicillin V could diminish therapeutic efficacy.
  • Resistance trends impact demand and formulary inclusion.

Supply Chain and Manufacturing

  • Dependence on generic manufacturing plants introduces risks related to supply disruptions.
  • Quality control remains critical to maintain regulatory compliance.

Future Outlook

  • Rising prevalence of bacterial infections supports ongoing demand.
  • Industry trend favors formulations that combine UTICILLIN VK with other antibiotics for broad-spectrum coverage.
  • Price erosion due to competitive pressures necessitates a focus on cost efficiency.

Comparative Analysis

Attribute UTICILLIN VK Alternative Penicillins Broader Antibiotics
Market Maturity High High Medium to Low
Patent Status Expired Expired Varies
Price Stability Declining Declining Variable
Resistance Trends Stable but risky Similar Increasing concerns

Legal and Patent Landscape

  • Patents for UTICILLIN VK have expired in major markets, encouraging generic manufacturing.
  • No recent patent litigations reported, but brand-specific formulations or combination products may carry exclusivity.

Strategic Considerations

  • Emphasize cost leadership given manufacturing efficiencies.
  • Monitor regional prescribing patterns and resistance trends.
  • Explore formulations or combination therapies to extend utility.
  • Invest in quality assurance to maintain regulatory compliance.

Key Takeaways

  • UTICILLIN VK remains a low-margin, volume-driven antibiotic with a stable but declining market share.
  • Market dynamics focus on price erosion, resistance, and regulatory policies.
  • Risk factors center on competitive pressures, resistance development, and supply chain reliability.
  • Growth prospects depend on global bacterial infection rates and formulary acceptance.

FAQs

1. What is the primary therapeutic use of UTICILLIN VK?

Treatment of bacterial infections such as pharyngitis, tonsillitis, and skin infections caused by susceptible bacteria.

2. How does patent status affect investment in UTICILLIN VK?

Expired patents facilitate generic manufacturing, leading to price competition and narrower profit margins.

3. What are the main risks for investors in UTICILLIN VK?

Market competition, bacterial resistance, regulatory changes, and supply chain disruptions.

4. How does bacterial resistance impact the demand for UTICILLIN VK?

Rising resistance reduces efficacy, decreasing demand and potentially leading to formulary restrictions.

5. What strategic moves could sustain UTICILLIN VK's market position?

Cost optimization, formulation innovation, and proactive resistance monitoring.


References

[1] U.S. Food and Drug Administration. (2022). Drug approvals and labels. https://www.fda.gov

[2] European Medicines Agency. (2022). Medicinal product authorization. https://www.ema.europa.eu

[3] IQVIA. (2022). Global antibiotic market analysis. https://www.iqvia.com

[4] World Health Organization. (2021). Antimicrobial resistance surveillance. https://www.who.int

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