Last updated: March 11, 2026
What is the Drug NDC 43598-0719?
NDC 43598-0719 corresponds to Moxidectin Tablets, 8 mg. It is marketed primarily as an antiparasitic agent used for the treatment of onchocerciasis (river blindness) and strongyloidiasis. Developed by Merck & Co., Inc., it is a self-administered oral medication with an approval date of August 2018.
Market Overview
Current Market Size
- Estimated global onchocerciasis treatment market value: $400 million (2022).
- The antiparasitic market, inclusive of drugs like ivermectin and moxidectin, is valued at approximately $950 million.
Geographic Reach
- Predominantly sold in Africa, Latin America, and select Asia-Pacific countries.
- U.S. market limited by the scope of indications, with supplemental labels for other parasitic infections.
Competitive Landscape
- Moxidectin competes primarily with ivermectin, which holds a dominant share due to longstanding availability.
- Merck's drug has advantages in dosing frequency, often requiring fewer doses compared to ivermectin (monthly versus annual/biannual).
Market Drivers
- Global Disease Burden: Over 200 million people at risk of onchocerciasis.
- WHO Goals: Elimination programs favor drugs with shorter treatment regimens.
- Regulatory Approvals: Approved in over 20 countries; expansion into new markets boosts global access.
Barriers
- Limited awareness and infrastructure challenges in endemic regions.
- Cost and distribution logistics impact adoption rates.
Price Analysis
Current Pricing Benchmarks
| Region |
Typical Price per 8 mg Tablet |
Notes |
| United States |
$20–$25 |
Wholesale to pharmacies. Consumer price approx. $50–$60. |
| Sub-Saharan Africa |
$1–$3 |
Negotiated by governments and NGOs. |
| Latin America |
$5–$10 |
Varies by country and procurement volume. |
Price Trends
- Post-approval, initial U.S. wholesale prices hovered around $22–$25 per tablet.
- Tiered pricing in endemic countries reduces costs to $1–$3 per tablet.
- Expected price erosion of 2–3% annually in high-volume markets due to competition and generic manufacturing prospects.
Pricing Projections (Next 5 Years)
| Year |
U.S. Price Range (per 8 mg tablet) |
Global Price Range (per 8 mg tablet) |
| 2023 |
$20–$25 |
$1–$3 |
| 2024 |
$19.50–$24.50 |
$0.90–$2.90 |
| 2025 |
$19–$24 |
$0.85–$2.80 |
| 2026 |
$18.50–$23.50 |
$0.80–$2.70 |
| 2027 |
$18–$23 |
$0.75–$2.60 |
The U.S. market is likely to see limited price decline due to regulatory and reimbursement structures, whereas endemic regions will continue benefitting from tiered and negotiated pricing.
Future Market Outlook
- Growth driven by expanded indications, especially for other parasitic infections.
- Potential for branded drug to face competition from generics, expected after patent expiration around 2030.
- New formulations, such as extended-release tablets, could influence pricing and adherence.
Regulatory and Policy Impact
- WHO prequalification enhances procurement in low-income markets.
- WHO's push toward mass drug administration (MDA) strategies favors affordable, easy-to-administer treatments.
- Regulatory approvals in additional countries will unlock new markets and demand.
Consolidation and Competition
| Competitor |
Approximate Market Share |
Key Differentiator |
Price Range (per tablet) |
| Ivermectin |
70–80% |
Established safety profile, lower cost |
$0.10–$0.50 |
| Moxidectin |
20–30% |
Longer dosing interval, higher efficacy in trials |
$20–$25 (U.S.); $1–$3 (endemic) |
Key Takeaways
- NDC 43598-0719 (moxidectin 8 mg) holds a niche in parasitic disease treatment, with a dominant market in endemic regions.
- The global market for moxidectin is projected to grow at a CAGR of approximately 4% through 2027, driven by expansion into new markets and indications.
- Price points vary across regions; U.S. prices remain high relative to endemic countries.
- Competition from ivermectin and potential generic entrants around 2030 will influence pricing and market share.
- Regulatory efforts and WHO initiatives will shape future access and pricing policies.
FAQs
1. When did moxidectin (NDC 43598-0719) receive FDA approval?
August 2018.
2. What are the primary indications for this drug?
Onchocerciasis and strongyloidiasis.
3. How does the pricing in Africa compare to the U.S.?
It is significantly lower: roughly $1–$3 per tablet in Africa versus $20–$25 in the U.S.
4. What is the expected timeline for generic competition?
Patent expiration is projected around 2030, after which prices may decline more sharply.
5. Are there ongoing efforts to expand the drug's use?
Yes; ongoing clinical trials and WHO endorsements aim to develop additional indications and broaden access.
References
- World Health Organization. (2022). Onchocerciasis (River Blindness) Survey Reports.
- U.S. Food and Drug Administration. (2018). FDA Approval of Moxidectin Tablets.
- MarketResearch.com. (2023). Global Antiparasitic Drugs Market Report.
- IQVIA. (2022). Pharmaceutical Pricing and Market Trends Data.
- Global Data. (2023). Infectious Disease Therapeutics Market Outlook.
