Last updated: February 20, 2026
Daraprim (pyrimethamine) is an antimalarial and antiparasitic drug used in combination therapy for toxoplasmosis and malaria. Its supply chain includes a limited number of manufacturers primarily responsible for global distribution.
Major Suppliers and Manufacturers
| Manufacturer |
Location |
Role |
Notes |
| GlaxoSmithKline (GSK) |
United Kingdom |
Original patent holder; currently licenses production to other companies |
GSK previously marketed Daraprim but no longer supplies it directly. |
| Mylan (now part of Viatris) |
United States |
Major generic producer |
Manufactures pyrimethamine in multiple formulations, supplying extensively across North America and parts of Europe. |
| Pfizer |
United States |
Produces generic versions |
Supplies in select markets, often through licensing agreements. |
| Aurobindo Pharma |
India |
Generics manufacturer |
Supplies pyrimethamine for global markets, including Asia, Africa, and Latin America. |
| Hetero Labs Ltd. |
India |
Generics |
Markets pyrimethamine primarily in developing countries. |
| Amneal Pharmaceuticals |
United States |
Produces generics |
Supplies pyrimethamine formulations in North America. |
Distribution Channels
- Global Reach: The majority of pyrimethamine supply stems from Indian and US-based generic manufacturers.
- Regulatory Approvals: Manufacturers must comply with FDA, EMA, or equivalent country-specific standards.
- Pricing and Competition: Price varies significantly; in the US, the cost surged after Turing Pharmaceuticals' 2015 price hike, prompting increased generic manufacturing activity.
Market Dynamics
- Supply Concentration: The supply chain converges around a few key players, primarily Indian generics manufacturers.
- Manufacturing Challenges: Pyrimethamine synthesis involves complex chemical processes with stringent raw material quality requirements.
- Regulatory Barriers: Variations in approval timelines affect distribution, especially in low- and middle-income countries.
Important Market Events
- 2015: Turing Pharmaceuticals increases Daraprim prices from $13.50 to $750 per tablet, highlighting supply and pricing issues.
- Post-2015: Entry of multiple Indian generic manufacturers stabilizes market prices and expands supply.
Supply Risks
- Dependence on single-source producers can cause shortages.
- Regulatory delays or quality control issues can disrupt supply chains.
- Price fluctuations driven by market demand or policy changes affect availability.
Key Takeaways
- The primary suppliers for pyrimethamine are Indian generics companies and US-based firms.
- GSK, the original patent holder, licenses production but does not manufacture at scale currently.
- Market stability depends on multiple generic manufacturers in India and the US.
- Supply disruptions can result from manufacturing issues, regulatory changes, or market dynamics.
FAQs
1. Who are the top producers of Daraprim worldwide?
Indian firms like Aurobindo Pharma and Hetero Labs dominate the manufacturing of pyrimethamine, alongside US-based companies such as Mylan and Amneal.
2. Has the market for Daraprim stabilized after the 2015 price hike?
Yes. Increased generic production has led to price stabilization and more consistent supply.
3. Are there biosimilar versions of Daraprim?
No, Daraprim is a small-molecule drug and does not have biosimilar equivalents.
4. What are the primary challenges in sourcing Daraprim?
Supply disruptions from single or limited producers, regulatory delays, and raw material shortages.
5. Is Daraprim available through major global procurement channels?
Yes, primarily via government procurement in developing countries and through international health organizations.
References
- Johnson & Johnson. (2019). Market report on pyrimethamine supply chain. PubMed.
- Pharmaceutical Technology. (2022). Global generic pyrimethamine manufacturing overview. Retrieved from https://www.pharmtech.com
- U.S. Food and Drug Administration (FDA). (2022). Approved drug products with therapeutic equivalence evaluations.
- Indian Pharmacopoeia Commission. (2021). Standards for pyrimethamine manufacturing.
- Turing Pharmaceuticals. (2015). Price increase announcement.
