Last updated: February 19, 2026
Multiple pharmaceutical companies produce lonafarnib, a prenylation inhibitor used in rare genetic disorders and some cancers. The drug's manufacturing, licensing, and distribution are divided across different firms, primarily through licensing agreements with originators.
Key Suppliers and Licensing Agreements
| Supplier |
Role |
Licensing/Manufacturing Details |
Notes |
| Eiger BioPharmaceuticals |
Commercial rights holder in North America |
Owns the rights for several indications, including progeria |
Licensed from Merck (formerly Schering-Plough) |
| Merck & Co. |
Original developer and patent holder |
Developed lonafarnib; licensed rights to Eiger in North America |
Distributes through licensing agreements |
| Catalent |
Contract manufacturer for clinical and commercial supplies |
Produces the drug bulk, licenses depend on agreements |
Uses facilities compliant with cGMP standards |
| Other contract manufacturers |
Small-scale production and custom synthesis |
Various firms in Europe and Asia, including WuXi AppTec |
Limited data on specific suppliers |
Licensing and Distribution
- Eiger BioPharmaceuticals holds the licensing rights for lonafarnib in North America and is responsible for its commercialization in this region.
- Merck was the original patent owner and continues to oversee certain global rights outside North America.
- License agreements specify manufacturing, distribution, and sales territories, with Eiger managing supply chain activities within North America under licensing terms with Merck and other sublicensees.
Manufacturing Scope and Capabilities
- Primary manufacturing site: Catalent facilities, which comply with regulatory standards for clinical and commercial production.
- Additional manufacturing: Contract firms in Asia and Europe, used mainly for early-phase clinical supplies or regional distribution.
Market Status and Supply Chain Risks
- Limited number of manufacturers constrains supply; production relies heavily on contract manufacturing organizations (CMOs).
- Supply disruptions could impact availability, as seen with supply shortages reported in certain regions due to scaling issues at manufacturing facilities.
Regulatory and Patent Landscape
| Year |
Event |
Impact |
| 2007 |
Merck patents filed for lonafarnib |
Patent protection extended until at least 2025 |
| 2013 |
Orphan drug designation granted by FDA |
Facilitates exclusivity and potential market control |
| 2017 |
Merck licenses rights to Eiger in North America |
Eiger becomes primary supplier and marketer in North America |
Summary of Key Suppliers
- Eiger BioPharmaceuticals: Main supplier for North American markets; owns licensing rights.
- Merck & Co.: Original patent holder; licensing rights in regions outside North America.
- Catalent & other CMOs: Responsible for manufacturing bulk drug and finished pharmaceutical products.
Key Takeaways
- Lonafarnib manufacturing is primarily controlled through licensing agreements involving Merck and Eiger.
- Limited supplier base increases vulnerability to supply disruptions, especially in regions relying on contract manufacturers.
- Regulatory exclusivities, including orphan drug status, influence market dynamics and patent lifespan until at least 2025.
FAQs
1. Who manufactures lonafarnib for the North American market?
Eiger BioPharmaceuticals licenses manufacturing from contract manufacturers such as Catalent, with rights granted by Merck.
2. Are there multiple manufacturers of lonafarnib globally?
While several contract manufacturers may produce the drug for clinical trials, few companies have the capacity for large-scale commercial supply.
3. How long will lonafarnib's patent protection last?
Patent protection is likely valid until at least 2025, with orphan drug status extending market exclusivity.
4. What risks exist in the supply chain for lonafarnib?
Dependence on limited contract manufacturing organizations could lead to supply shortages if production issues occur.
5. Are there regional differences in lonafarnib suppliers?
Yes. In North America, Eiger manages supply; elsewhere, Merck's licensing agreements dictate manufacturing and distribution rights.
References
- APA citation for licensing and manufacturing data in the public domain.
- Food and Drug Administration (FDA). (2013). Orphan drug designations.
- Merck & Co. Annual reports, 2007-2022.
- Eiger BioPharmaceuticals. (2022). Corporate filings and press releases.
- Contract manufacturing industry reports, 2022.
