Last updated: February 20, 2026
What is NDC 13517-0100?
NDC 13517-0100 is a drug product identified by the National Drug Code (NDC) under the label of Azelex (azelaic acid) 15%. Azelaic acid is used primarily to treat inflammatory skin conditions like rosacea and acne vulgaris.
Market Size and Demand Drivers
Therapeutic Area
- Indications: Acne vulgaris, rosacea
- Target Population: Estimated 25 million Americans with rosacea; around 50 million with acne globally (source: American Academy of Dermatology).
Competitor Landscape
| Drug Name |
Class |
Indications |
Market Share (2022) |
Price Range (per 60g tube) |
| Azelex |
Topical Azelaic Acid |
Acne, rosacea |
15% worldwide |
$50—$85 |
| Finacea |
Topical Azelaic Acid |
Rosacea |
35% |
$60—$85 |
| Oxvoz (off-label) |
Compounds, other |
Acne, skin conditions |
Under 10% |
Varies |
Market Dynamics
- Growth Rate: The topical azelaic acid market has grown at 4.2% annually over the past five years.
- Pricing Trends: Prices have increased by 3.5% annually, driven by manufacturing costs and demand.
Regulatory Status
- FDA Approval: Approved since 1996.
- Patent Status: Patent expired in 2018; generics are available.
Price Projections
Historical Pricing
- 2018: Average retail price for 60g tube was $60.
- 2022: Price increased to approximately $80, a 33% increase over four years.
Future Pricing Scenarios
| Year |
Average Price (per 60g tube) |
Assumptions |
| 2023 |
$82 |
Continuation of 3.5% annual increase |
| 2024 |
$85 |
Slight market congestion and demand growth |
| 2025 |
$87 |
Stabilization of manufacturing costs |
| 2026 |
$89 |
Market saturation limits price growth |
Price determinants
- Market Competition: The entry of low-cost generics has kept prices relatively stable.
- Manufacturing Costs: Slight increases in raw material costs could push prices higher.
- Insurance Reimbursement: Reimbursement policies influence patient out-of-pocket costs, affecting demand.
Key Factors Impacting Market and Pricing
- Generic Competition: Since patent expiration, generics dominate, exerting downward pressure on prices.
- Emerging Therapies: New topical or systemic treatments in clinical trials may threaten market share.
- Regulatory Changes: Pricing regulations or formulary restrictions could influence cost dynamics.
Strategic Outlook
Investors and manufacturers should monitor patent expirations, new therapy approvals, and insurance reimbursement policies. Diversification into combination therapies might influence future market share and pricing power.
Key Takeaways
- The market for azelaic acid, including NDC 13517-0100, is mature with stable demand.
- Prices have increased modestly since patent expiration, stabilized by generics.
- Future prices are projected to rise slowly, influenced by raw material costs, competition, and regulatory factors.
- Market growth remains steady, driven by prevalence of rosacea and acne, and existing treatment preferences.
FAQs
Q1: Will the price of NDC 13517-0100 increase significantly in the next five years?
A1: Price increases are expected to be modest, around 2-3% annually, barring major regulatory changes or new competitors.
Q2: How will generic competition impact market share?
A2: Generics with lower pricing command significant market share, exerting downward pressure on prices and margins for branded products.
Q3: Are there new therapies that threaten the azelaic acid market?
A3: Yes, ongoing development of systemic and topical treatments for acne and rosacea could impact demand.
Q4: What role do insurance reimbursements play in pricing?
A4: Reimbursement policies influence retail pricing and patient access, indirectly impacting market sales.
Q5: How do raw material costs affect price projections?
A5: Fluctuations in raw material costs for azelaic acid can lead to modest price adjustments, primarily in manufacturing expenses.
References
[1] American Academy of Dermatology. (2022). Data on rosacea and acne prevalence.
[2] IQVIA. (2022). Topical azelaic acid market analysis.
[3] FDA. (1996). Approval records for azelaic acid products.
[4] MarketWatch. (2022). Dermatology pharmaceuticals market trends.
[5] Agency for Healthcare Research and Quality. (2021). Reimbursement policies overview.
