Last updated: February 20, 2026
Who are the primary manufacturers of Onfi?
Onfi (clobazam) is an anti-epileptic medication marketed primarily for managing Lennox-Gastaut syndrome. Its supply chain consists mainly of two pharmaceutical companies:
- Jazz Pharmaceuticals
- Lannett Company (as a generic manufacturer)
What companies manufacture Onfi?
| Company |
Role |
Market Presence |
Manufacturing Locations |
Notable Notes |
| Jazz Pharmaceuticals |
Proprietary brand: Onfi |
Global, primarily US, UK, EU |
US, UK |
Original patent holder, marketed brand Onfi |
| Lannett Company |
Generic manufacturer |
US only |
US |
Produces generic clobazam; received FDA approval |
When did these companies begin supplying Onfi?
- Jazz Pharmaceuticals launched Onfi in 2011 following FDA approval in 2011 for Lennox-Gastaut syndrome.
- Lannett Company received FDA approval for generic clobazam in December 2017; began commercial distribution shortly after.
How do suppliers distribute Onfi?
- Jazz Pharmaceuticals handles global distribution, with a network of specialty pharmacies, hospitals, and clinics.
- Lannett supplies primarily through the US market via wholesale distributors, pharmacies, and healthcare providers.
What are alternative sources and generic options?
- Generic versions produced by Lannett Company and other approved manufacturers can serve as substitutes for Onfi.
- The FDA grants approval based on bioequivalence, ensuring comparable efficacy and safety.
Supply chain considerations:
- Production relies on active pharmaceutical ingredient (API) imports, predominantly sourced from suppliers in China and India.
- API quality and regulatory compliance are critical factors affecting supply stability.
- Manufacturing capacity constraints and regulatory reviews can impact availability.
Notable regulatory actions affecting suppliers
- FDA approvals for generics expand market competition, potentially lowering prices.
- Patents held by Jazz Pharmaceuticals expired in some jurisdictions, enabling more generic entrants.
- Supply disruptions have occurred due to manufacturing issues or API shortages.
Key companies involved in API supply
| Company |
Country |
Role in API Production |
Notable Features |
| Zhejiang Huahai Pharmaceutical |
China |
API production |
Experienced in benzodiazepines API |
| Sun Pharmaceutical Industries |
India |
API production |
Major active API supplier |
Market Outlook
- Increased generic competition is expected to reduce Onfi pricing.
- Ongoing API supply chain stability is crucial for consistent availability.
- Regulatory considerations continue to shape manufacturing and supply.
Summary
Primary suppliers for Onfi include Jazz Pharmaceuticals, which markets the brand version globally, and generic manufacturers such as Lannett Company in the US. API sourcing from China and India influences manufacturing capacity and supply stability. Regulatory approvals of generics expand availability and drive pricing pressures.
Key Takeaways
- Jazz Pharmaceuticals is the main proprietary seller of Onfi.
- Generic clobazam is supplied by multiple manufacturers, chiefly Lannett.
- API manufacturing relies heavily on Chinese and Indian producers, influencing supply continuity.
- Patent expirations and FDA approvals permit increased generic competition, impacting market dynamics.
- Supply stability depends on API quality, regulatory compliance, and manufacturing capacity.
FAQs
1. Who holds the patent for Onfi?
Jazz Pharmaceuticals held the patent before it expired in some jurisdictions, paving the way for generic entrants.
2. Are there alternative drugs for Lennox-Gastaut syndrome?
Yes, medications like rufinamide, lamotrigine, and topiramate are also used, but Onfi is approved specifically for Lennox-Gastaut.
3. How does FDA approval affect generic suppliers?
FDA approval certifies bioequivalence, enabling generics to enter the market legally and competitively.
4. What factors influence the supply chain of Onfi?
API sourcing, manufacturing capacity, domestic and international regulatory compliance, and geopolitical issues.
5. Are there shortages of Onfi?
Supply disruptions have occurred but are generally resolved quickly. Ongoing API sourcing issues or manufacturing problems could induce shortages.
References
- FDA. (2017). FDA approves generic clobazam for Lennox-Gastaut syndrome. Retrieved from https://www.fda.gov
- Jazz Pharmaceuticals. (2022). Onfi (clobazam) prescribing information. Retrieved from https://www.jazzpharma.com
- Lannett Company. (2020). Generic clobazam approval and product details. Retrieved from https://lannett.com
- API Market Reports. (2021). Supply chain analysis of benzodiazepine APIs. Retrieved from industry reports.
