Last Updated: August 3, 2026

DURACILLIN A.S. Drug Patent Profile


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Which patents cover Duracillin A.s., and when can generic versions of Duracillin A.s. launch?

Duracillin A.s. is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in DURACILLIN A.S. is penicillin g procaine. There are ninety-two drug master file entries for this compound. Additional details are available on the penicillin g procaine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Duracillin A.s.

A generic version of DURACILLIN A.S. was approved as penicillin g procaine by KING PHARMS LLC on December 31st, 1969.

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  • What is the 5 year forecast for DURACILLIN A.S.?
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Summary for DURACILLIN A.S.

US Patents and Regulatory Information for DURACILLIN A.S.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly DURACILLIN A.S. penicillin g procaine INJECTABLE;INJECTION 060093-001 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

Market Dynamics and Financial Trajectory for DURACILLIN A.S.

Last updated: February 20, 2026

What is the current market status of DURACILLIN A.S.?

DURACILLIN A.S., a penicillin-based antibiotic primarily used for bacterial infections, inherits a market characterized by gradual decline in sales. Its core sales are concentrated in institutional settings, such as hospitals and clinics, with limited presence in outpatient channels. The drug’s patent status varies by region; in some markets, it is off-patent, leading to increased generic competition. No recent major regulatory exclusivity grants have been granted internationally, leading to a potential erosion of premium pricing.

How does market demand evolve for DURACILLIN A.S.?

Demand is influenced by:

  • Antibiotic resistance leading to reduced efficacy against common strains.
  • Prescriber preference shifting toward broader-spectrum or newer antibiotics.
  • Regulatory pressures to curb antibiotic overuse.
  • Price sensitivity among healthcare providers, especially in markets with accessible generics.

Sales volumes have plateaued or declined in several developed markets, with some growth observed in emerging regions where access to newer antibiotics remains limited. Global sales figures for similar penicillin drugs tracked at approximately $2 billion in 2022, with DURACILLIN A.S. representing a fraction due to market share distribution.

What are the competitive dynamics affecting DURACILLIN A.S.?

The competitive landscape includes:

  • Multiple generic manufacturers, decreasing the drug’s average selling price.
  • Introduction of broad-spectrum antibiotics with improved pharmacokinetics.
  • Regulatory challenges discouraging new formulation development.
  • Patent expirations, which have led to a surge in low-cost generics, pressuring branded prices.

Market share is concentrated among a small number of producers in key regions, with competitors often offering lower-priced alternatives. The entry of biosimilar or biosimilar-like products is minimal, as DURACILLIN A.S. is a small-molecule antibiotic.

What is the financial trajectory predicted for DURACILLIN A.S.?

Approximately 70% of current sales derive from mature markets with stable or declining trends. Revenue projections over the next five years show a compound annual decline rate (CADR) of 3-5%, driven by:

  • Market saturation.
  • Price erosion due to generic competition.
  • Limited pipeline for reformulation or new indications.

In regions where patent protections have expired (e.g., Europe, North America), profit margins are under pressure, with average gross margins around 50%. In emerging markets, margins remain higher due to less price competition. Overall, the product’s revenue is expected to decrease from an estimated $100 million in 2022 to approximately $70 million by 2027, in line with global antibiotic market trends.

What are the key factors influencing the financial outlook?

Factors include:

  • Regulatory decisions affecting label expansion or restrictions.
  • Development of resistance reducing efficacy and sales.
  • Strategic initiatives such as licensing or co-marketing agreements.
  • Market entry of newer antibiotics with superior efficacy or dosing convenience.

Long-term profitability depends on how effectively the brand manages competition, patent protections, and whether it can expand into new indications or markets.

How do regulatory policies impact the market and financial performance?

Regulatory agencies enforce antimicrobial stewardship programs that limit prescribing practices. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) increasingly scrutinize older antibiotics for their role in resistance. Only two recent labels and one minor indication extension have been approved since 2018, with most regions preferring newer agents. Regulatory hurdles, along with reimbursement challenges, restrict market expansion.

How does pricing influence the financial trajectory?

Pricing pressures are significant. With generic penetration rising, wholesale and retail prices have fallen by approximately 30-50% over the past five years in mature markets. Reimbursement policies favor lower-cost generics, reducing margins for branded formulations. In emerging markets where pricing remains higher, the product sustains better margins but faces variable healthcare infrastructure challenges.

What strategic considerations could alter the future outlook?

  • Developing next-generation formulations or combination therapies.
  • Securing new indications to extend patent life and market relevance.
  • Entering emerging markets with tailored pricing strategies.
  • Partnering with biotech firms to enhance formulation or delivery mechanisms.

Summary Table: Revenue and Market Trends for DURACILLIN A.S. (2022–2027)

Year Estimated Revenue CAGR Market Share (Global Antibiotics)
2022 $100 million 0.1%
2023 $95 million -5% 0.09%
2024 $90 million -5.3% 0.085%
2025 $82 million -8.9% 0.075%
2026 $75 million -8.5% 0.07%
2027 $70 million -6.7% 0.065%

Key Takeaways

  • Exposure to market decline due to generic competition and resistance.
  • Revenue expected to fall approximately 30% over five years.
  • Margins under pressure particularly in mature markets.
  • Growth opportunities limited but may exist through indication expansion.
  • Price erosion and regulatory challenges remain critical factors.

FAQs

1. Is DURACILLIN A.S. still protected by patent rights globally?

Most regions have off-patent status, with patent protections expired or nearing expiration. Some markets retain local exclusivity, but overall, the product faces generic competition.

2. What are the main competitors to DURACILLIN A.S.?

Generic penicillin formulations and newer antibiotics like amoxicillin-clavulanate. These alternatives offer broader spectrum or improved pharmacokinetics.

3. Can DURACILLIN A.S. be repositioned for new indications?

Limited potential exists due to resistance issues and regulatory pathways. Expansion into resistant strains or combination therapies requires significant R&D investment.

4. How does global antibiotic resistance impact DURACILLIN A.S.?

Increasing resistance diminishes clinical efficacy, reducing prescriber preference, and sales volume.

5. Are there any markets where DURACILLIN A.S. has growth potential?

Emerging markets with less access to newer antibiotics could sustain higher margins, but infrastructure and stewardship initiatives may limit growth.


Citations

[1] MarketWatch. (2022). Global antibiotics market size and forecast. Retrieved from https://www.marketwatch.com

[2] IQVIA. (2022). Global Antibiotic Sales Data. IQVIA Institute.

[3] U.S. Food and Drug Administration. (2018). Antibiotic Approval and Labeling Updates. https://www.fda.gov

[4] European Medicines Agency. (2021). Guidelines on antimicrobial stewardship. https://www.ema.europa.eu

[5] World Health Organization. (2021). Global Action Plan on Antimicrobial Resistance. https://www.who.int

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