Last updated: February 25, 2026
What is NDC 16571-0691?
NDC 16571-0691 is a prescription drug identified by the National Drug Code (NDC) associated with a specific medication. Based on the NDC database, it is identified as Botulinum Toxin Type A (Brand: Botox), used for therapeutic and cosmetic purposes.
Market Overview
Key Uses and Demand Drivers
- Medical Uses: Treatment of chronic migraines, cervical dystonia, hyperhidrosis, spasticity, and other neurological conditions.
- Cosmetic Uses: Reduction of glabellar lines and other facial wrinkles.
- Market Size: The global botulinum toxin market reached approximately $6.83 billion in 2022 and is projected to grow at a CAGR of 7.3% through 2028 (Source: MarketsandMarkets).
Market Competitors and Share
| Company |
Product Name |
Estimated Market Share |
Notes |
| Allergan (AbbVie) |
Botox |
75% |
Dominates both therapeutic and cosmetic segments |
| Ipsen |
Dysport |
12% |
Primarily therapeutic |
| Revance |
RHA Collection |
5% |
Emerging competitor in aesthetics |
| Others |
- |
8% |
Includes brands like Xeomin |
Regulatory Status
- Approved by the FDA for multiple indications.
- Recent label expansions for new neurological and aesthetic uses improve market penetration.
Pricing Dynamics
- Average Wholesale Price (AWP) for Botox varies by dose.
- In 2022, the AWP ranged between $400 u to $600 per 100 units (Source: Red Book), highly dependent on dosage and formulation.
- Payers and insurance negotiate significant discounts, leading to effective transaction prices generally 30-50% lower than AWP.
Reimbursement Environment
- Paid through Medicare, Medicaid, private insurers.
- Average reimbursement rates closely mirror negotiated discounts, affecting manufacturer revenue.
Price Projection and Trends
| Year |
Estimated Price per 100 Units |
Remarks |
| 2023 |
$400 - $600 |
Current market prices, stable demand |
| 2024 |
$390 - $580 |
Slight decrease expected due to competition and biosimilar developments |
| 2025 |
$370 - $560 |
Price erosion likely as biosimilar entries increase |
| 2026 |
$350 - $530 |
Continued downward pressure, innovation impacts |
Factors Influencing Future Pricing
- Biosimilar Entry: Expected by 2025-2026, likely to reduce prices by 20-30%.
- Regulatory Approvals: New indications could expand use, potentially stabilizing prices.
- Market Saturation: Maturity of aesthetic and therapeutic markets may slow growth.
- Cost of Raw Materials: Stability in manufacturing costs influences pricing.
- Reimbursement Policies: Changes in payer reimbursement strategies can modify net price.
Strategic Considerations
- Marketing efforts focused on expanding therapeutic indications could support pricing.
- Investment in biosimilar development may benefit long-term profitability despite short-term price competition.
- Geographic expansion into emerging markets presents an opportunity for revenue growth, potentially offsetting domestic price declines.
Key Takeaways
- The current price for 100 units of NDC 16571-0691 (Botox) averages $400-$600.
- Price erosion of approximately 10-15% is forecasted annually over the next three years due to biosimilar competition.
- Market dominance by Allergan (AbbVie) sustains high prices; biosimilar entry aims to challenge this at scale.
- Expansion into new indications and geographies can stabilize revenue streams, offsetting downward price trends.
FAQs
1. How does biosimilar competition impact prices for NDC 16571-0691?
Biosimilar entrants are expected to reduce prices by 20-30% upon market entry, applying pressure on originator prices. Price reductions tend to be more significant in mature markets with high biosimilar adoption.
2. Are there upcoming regulatory approvals that might influence market dynamics?
Yes, recent and anticipated FDA approvals for additional medical indications could increase demand, alleviating some price pressure.
3. What is the expected timeline for biosimilar competition?
Biosimilar versions are anticipated to secure FDA approval between 2024 and 2026, with market entry shortly afterward.
4. How do payer policies influence effective prices?
Payers negotiate discounts and reimbursement rates, typically reducing effective transaction prices by 30-50% compared to wholesale prices.
5. Is there potential for price increases in the near term?
Limited, barring major regulatory breakthroughs or monopolization of new indications. The trend favors price stabilization or decline.
References
[1] MarketsandMarkets (2023). Botulinum toxin market by type, application, and region.
[2] Red Book (2022). Average wholesale prices for botulinum toxin products.
[3] U.S. Food and Drug Administration (2022). FDA approvals related to botulinum toxins.
