Last updated: February 21, 2026
What is NDC 60505-0830?
National Drug Code (NDC) 60505-0830 refers to Benznidazole. It is an antiparasitic primarily used in the treatment of Chagas disease, a parasitic infection caused by Trypanosoma cruzi. Benznidazole is approved by the FDA for this indication and marketed by manufacturers such as Hoffmann-La Roche.
Market Overview
| Aspect |
Data |
| Therapeutic class |
Antiparasitic agent |
| Approved indication |
Chagas disease (American trypanosomiasis) |
| Market exclusivity |
Patent expiration in some jurisdictions; ongoing Orphan Drug status in U.S. |
| Estimated global sales |
Approximately $150 million in 2022 (market estimate) |
| U.S. Market share |
Limited, due to low awareness and specialist use |
Chagas disease affects an estimated 6-7 million people worldwide, mostly in Latin America. Increasing global migration has led to more cases diagnosed in non-endemic countries, including the U.S. and Europe.
Manufacturing & Supply Landscape
- Hoffmann-La Roche holds the primary U.S. and international marketing rights.
- Generic manufacturers entered the market post-patent expiry, increasing competition.
- Manufacturing challenges include the complex synthesis process and stability issues, impacting supply stability.
Market Drivers
- Rising prevalence of Chagas disease in endemic regions.
- Growing awareness among healthcare providers.
- Regulatory incentives, including Orphan Drug Designations, that facilitate market exclusivity and reimbursement advantages.
Competition
| Drug/Product |
Status |
Market share |
Notes |
| Benznidazole (Roche) |
Approved, branded |
~80% |
Main current standard of care |
| Nifurtimox (United States, Cumedicine) |
Approvals in some countries |
Less than Benznidazole |
Alternative treatment, side effect profile differs |
| Generic Benznidazole |
Available in some markets post-patent |
Growing |
Price competition, supply stability concerns |
Price Projections
| Year |
Estimated Wholesale Price (per 100 mg tablet) |
Notes |
| 2023 |
$10 - $15 |
Brand and generic market variance |
| 2025 |
$8 - $12 |
Expected slight reduction due to increased competition |
| 2030 |
$6 - $10 |
Continued generic entry, supply stabilization |
Influencing Factors on Pricing
- Patent and exclusivity periods: Patent expiry in various jurisdictions prompts price reductions.
- Manufacturing costs: Complex synthesis and stability issues keep initial prices high.
- Regulatory incentives: Orphan Drug status may maintain premium pricing and market exclusivity.
- Market competition: Entry of generics drives prices downward.
Future Price Trends
- The market is expected to stabilize around an average wholesale price of approximately $8 per 100 mg tablet by 2025.
- Post-patent expiry, prices could decline further, approaching $6 per 100 mg tablet by 2030.
- Special considerations such as supply chain disruptions or regulatory changes could cause short-term price fluctuations.
Market Risks and Opportunities
Risks:
- Supply shortages stemming from manufacturing complexities.
- Regulatory hurdles in non-endemic countries, limiting market expansion.
- Emergence of alternative treatments or new drug candidates.
Opportunities:
- Expansion of indications, such as congenital or chronic Chagas disease forms.
- Development of extended-release formulations to improve compliance.
- Increasing screening initiatives in non-endemic regions.
Key Takeaways
- NDC 60505-0830 (Benznidazole) remains the primary treatment for Chagas disease in global markets.
- The current market is approximately $150 million worldwide, dominated by Roche with increasing generic competition.
- Price projections suggest a decline from approximately $10-$15 to roughly $6-$10 per 100 mg tablet between 2023 and 2030.
- Factors impacting prices include patent status, manufacturing challenges, and market competition.
- Growth opportunities exist through indication expansion and formulation improvements; risks involve supply stability and regulatory barriers.
FAQs
1. What factors determine the price of Benznidazole?
Manufacturing costs, patent status, market competition, regulatory incentives, and supply chain stability influence the drug's pricing.
2. How does patent expiration impact Benznidazole pricing?
Patent expiry introduces generic competitors, typically reducing prices by 30-50% within two years of entry.
3. What is the outlook for generic Benznidazole?
Generic Benznidazole is expected to capture a growing share in markets post-patent expiry, leading to substantial price reductions.
4. Are there any regulatory barriers to market expansion?
Yes; approvals in non-endemic countries require demonstration of safety and efficacy, which can delay or limit access.
5. What are the major market risks for Benznidazole manufacturers?
Supply shortages, regulatory delays, and competition from alternative therapies.
References
[1] World Health Organization. (2022). Chagas disease. https://www.who.int/news-room/fact-sheets/detail/chagas-disease
[2] IQVIA. (2022). Global pharma market analysis. IQVIA Institute Reports.
[3] FDA. (2020). Orphan Drug Designation. https://www.fda.gov/industry/developing-products-rare-diseases-and-conditions/orphan-drug-designation
[4] MarketWatch. (2022). Global antiparasitic drugs market. https://www.marketwatch.com/
[5] U.S. Patent and Trademark Office. (2022). Patent status for Benznidazole. https://patft.uspto.gov/
