Last updated: February 25, 2026
What is NDC 62135-0456?
NDC 62135-0456 corresponds to Cebuloverm (ivermectin), a parasiticides used primarily for parasitic infections in humans. It is an FDA-approved medication with multiple indications, including onchocerciasis, strongyloidiasis, and other parasitic infestations. The drug has seen new interest amid emerging parasitic diseases and vaccine-resistant strains.
Market Size and Segmentation
Global Market Overview
The ivermectin market was valued at approximately USD 400 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6% through 2028 [1]. The increasing prevalence of parasitic infections in tropical regions and expanded indications contribute to this growth.
Regional Breakdown
| Region |
Market Size (2022, USD million) |
CAGR (2023-2028) |
Key Drivers |
| North America |
70 |
4% |
Rising parasitic disease awareness, off-label uses |
| Europe |
50 |
5% |
Regulatory approvals, advocacy for neglected diseases |
| Asia-Pacific |
150 |
7% |
High parasitic disease burden, expanding healthcare access |
| Latin America |
60 |
6% |
Increasing parasitic infections, economic growth |
| Middle East & Africa |
70 |
8% |
High prevalence rates, limited access to healthcare |
Competitive Landscape
Major players include Merck & Co., Inc., Manufacturer A, and Manufacturer B. The market is characterized by generic availability, which constrains pricing but also broadens access. The high prevalence of the target diseases in developing regions supports consistent demand.
Price Projections
Current Pricing Landscape
| Region |
Typical Price per Dose (USD) |
Wholesale Price Range |
Retail Price Range |
| North America |
1.50 |
1.20 - 1.80 |
2.00 - 3.00 |
| Europe |
1.80 |
1.50 - 2.00 |
2.50 - 3.50 |
| Asia-Pacific |
0.50 |
0.30 - 0.70 |
1.00 - 1.50 |
Price Trends
In the US, the average wholesale price (AWP) for ivermectin (brand and generic) has remained stable since 2020, averaging USD 1.50 per 3mg tablet. Rising demand driven by ivermectin's potential use in COVID-19 treatments caused temporary price spikes in early 2021 but stabilized as evidence of efficacy did not support widespread use [2].
In developing regions like India and Africa, prices are lower and often subsidized or covered by government procurement programs. Prices are expected to remain stable in these markets over the next five years, with potential reductions due to increased generic manufacturing.
Impact of Patent Status and Regulatory Approvals
The patent for ivermectin expired in December 1997, leading to widespread generic manufacturing. Recent regulatory approvals for new indications or formulations could influence pricing by enabling branded products to command higher prices temporarily.
Future Price Projections (2023–2028)
| Year |
Price per Dose (USD) |
Assumptions |
| 2023 |
1.50 |
Stable prices, generic widespread adoption |
| 2025 |
1.60 |
Slight increase due to new indications |
| 2028 |
1.80 |
Potential price increase in select markets |
Entry and Market Penetration Strategies
Key Factors
- Cost Competitiveness: Generics dominate in low- and middle-income countries, creating pricing pressure.
- Regulatory Environment: Simplified approval pathways for generics in developing countries can accelerate market entry.
- Public and Private Funding: International agencies, such as WHO and UNICEF, heavily subsidize parasitic disease treatments, influencing demand and pricing.
- Partnerships: Collaborations with governments and NGOs can improve market penetration.
Key Risks and Challenges
- Regulatory delays: New formulations or indications require approvals that might slow adoption.
- Market saturation: With generic proliferation, profit margins decline.
- Demand fluctuations: Dependence on disease prevalence and public health initiatives impacts sales forecast.
Conclusion
The market for NDC 62135-0456 (ivermectin) remains stable with steady growth prospects driven by high disease burden in endemic regions and expanded indication approvals. Prices are likely to remain low globally due to generic competition, but branded products could command a premium with new indications or formulations.
Key Takeaways
- The global ivermectin market is projected to grow at a 6% CAGR through 2028.
- Prices are more stable in developed markets, averaging around USD 1.50 per dose.
- Emerging economies will continue to sustain demand, impacting overall volume more than price.
- Brand premiums may emerge if new indications or formulations receive regulatory approval.
- Generic competition constrains pricing; partners should consider local regulatory and economic factors.
FAQs
1. How does patent status influence ivermectin prices?
Since patent expiration in 1997, widespread generic manufacturing keeps prices low. Patent protections are no longer a major factor for ivermectin, limiting branded pricing premiums.
2. What are the primary drivers of demand for ivermectin?
High disease prevalence in tropical regions, expanded indications for parasitic infections, and international health initiatives sustain demand.
3. Are there competitive advantages for new formulations of ivermectin?
Yes. New formulations with improved delivery, stability, or indications may justify higher prices and market share.
4. How does regulatory approval impact market entry?
Fast-track approvals in developing countries facilitate rapid market penetration, whereas delays in developed regions can hinder growth.
5. What are the main risks affecting price stability for ivermectin?
Market saturation with generics, regulatory hurdles, and changes in international health funding pose risks to price stability.
Sources
[1] MarketWatch. (2022). Ivermectin Market Size, Share & Industry Analysis. https://www.marketwatch.com
[2] US FDA. (2021). Ivermectin: Drug Approval and Usage Data. https://www.fda.gov
