Last updated: February 20, 2026
What is the drug represented by NDC 69584-0427?
The drug identified by NDC 69584-0427 is Eladyn (Clavulanate Potassium and Amoxicillin) oral suspension. It is approved for bacterial infections such as respiratory tract, urinary tract, skin, and soft tissue infections.
Market Overview
Eladyn operates in the broad antibiotic segment, with a focus on pediatric and adult oral formulations. The global antibiotics market, valued at approximately $52 billion in 2022, is characterized by steady growth driven by rising bacterial infections, aging populations, and increasing resistance patterns.
The US antibiotic market specifically accounts for ~30% of this value, with the oral antibiotic segment comprising a significant portion due to outpatient prescriptions. Eladyn holds a niche in pediatric and general infections, competing mainly with other penicillin-based combination drugs.
Competitive Landscape
| Key Competitors |
Drug Name |
Formulation |
Price Range (per unit) |
Market Share (est. 2022) |
| Pfizer |
Augmentin (Amoxicillin/Clavulanate) |
Tablets, suspension |
$2 - $4 per tablet |
35% |
| GlaxoSmithKline |
Augmentin XR |
Extended-release tablets |
$6 - $10 per dose |
20% |
| Teva Pharmaceuticals |
Generic Amoxicillin/Clavulanate |
Tablets, suspension |
$1.50 - $3 per unit |
15% |
| Other generics |
Various |
Various |
$0.80 - $2 per unit |
30% |
Eladyn's market share is limited, primarily due to generic competition and formulations. Its phase of exclusivity, if any, is crucial to ascertain price premiums.
Regulatory Status
Eladyn is approved for pediatric and adult use, with an expiration date for patent protections expected in the next 1-2 years, opening pathways for generics.
Price Trends and Projections
Current Pricing (2023)
- Brand-name Eladyn suspension: approximately $15 - $20 per 150 mL bottle.
- Generics: range from $8 - $12 per 150 mL bottle, with stable prices over the last 24 months.
Factors Influencing Future Pricing
- Patent Expiry: Anticipated within 12-24 months; generic entry expected to drastically lower prices.
- Supply Chain Dynamics: Raw material costs (penicillin derivatives) remain stable but could fluctuate due to demand and COVID-19 related disruptions.
- Regulatory Approvals: New formulations or indications could influence pricing strategies.
- Market Share Trends: Generic penetration could reduce average prices by up to 50% within 1 year post-patent expiry.
Price Projections (Next 3 Years)
| Year |
Expected Average Price (per 150 mL bottle) |
Notes |
| 2023 |
$12 - $20 |
Current market conditions |
| 2024 |
$6 - $10 (post-patent expiry) |
Entry of generics, increased competition |
| 2025 |
$4 - $7 |
Market stabilization, new generic entrants |
Market Entry and Revenue Impact
For a pharmaceutical manufacturer planning to introduce a generic version, initial pricing could be set at $4 - $6 per 150 mL bottle, capturing significant market share from brand-name competitors within 6 months. Revenue projections depend on volume sales, with sales potential estimated at 1-3 million units annually in the US market alone upon full generic market penetration.
Revenue Estimation Scenarios
| Scenario |
Market Share |
Estimated Annual Revenue (USD) |
Key Assumptions |
| Optimistic (post-patent) |
60% |
$30 million - $40 million |
Rapid generic adoption, stable demand |
| Moderate |
40% |
$15 million - $20 million |
Gradual market replacement, price erosion |
| Conservative |
20% |
<$10 million |
Limited uptake, high competition |
Key Takeaways
- Eladyn faces intense generic competition, especially after patent expiry.
- Pricing is expected to decrease by up to 75% over two years post-patent expiration.
- Revenue potential hinges on market penetration rates and competition.
- Supply chain stability and regulatory developments could influence pricing dynamics.
- The next 1-2 years will be critical for understanding market share shifts.
FAQs
Q1: When does Eladyn’s patent protection expire?
A1: Estimated within 12-24 months, based on filings and patent life extensions.
Q2: What is the primary competitor for Eladyn?
A2: Augmentin, especially the generic versions, represents the dominant competition.
Q3: How might COVID-19 impact prices or supply?
A3: Disruptions can lead to increased raw material or distribution costs, but recent trends show stabilization.
Q4: Are there any pending approvals or formulations?
A4: No public data indicates upcoming formulations; focus remains on generic entry post-patent expiry.
Q5: Which regions besides the US offer potential market opportunities?
A5: The European Union and emerging markets present growth opportunities, particularly for generics.
References
- IBISWorld. (2023). Antibiotics Market in the US. Market Research Reports.
- Goodman & Gilman’s The Pharmacological Basis of Therapeutics. (13th ed.).
- FDA. (2022). Approved Drugs Database. [https://www.accessdata.fda.gov/scripts/cder/daf/]
- IQVIA. (2022). US Prescription Drug Market Data.
- EvaluatePharma. (2022). 2022 World Preview: Outlook to 2027.
