Last updated: February 20, 2026
Who are the producers of Aubagio?
Aubagio (generic name: teriflunomide) is marketed primarily by Sanofi. The drug was approved by the U.S. Food and Drug Administration (FDA) on September 13, 2013, for the treatment of relapsing forms of multiple sclerosis (MS). As of 2023, Sanofi remains the sole manufacturer of the branded formulation.
Is Aubagio available as a generic?
No authorized generic or generic alternative from other manufacturers has been approved or marketed. Teriflunomide is protected by patents held by Sanofi, preventing generic entry until patent expiry or patent challenges.
Patent and exclusivity landscape
Sanofi holds patents protecting Aubagio until at least 2030. These patents cover formulations, methods of use, and manufacturing processes. The exclusivity period limits generic competition through regulatory and patent barriers.
| Patent Expiry Year |
Patent Type |
Description |
| 2029–2030 |
Composition of Matter |
Basis for the drug substance |
| 2029 |
Method of Use |
Specific MS treatment indications |
| 2028 |
Manufacturing Process |
Methods for synthesizing teriflunomide |
[1] U.S. Patent No. 8,464,498; No. 8,868,121; No. 9,138,350.
Contract manufacturing
Sanofi handles production internally and may outsource some manufacturing operations. No publicly available third-party manufacturers supply Aubagio under licensing agreements.
Distribution channels
Primary distribution occurs through Sanofi's global supply chain. The drug is available via wholesale distributors, specialty pharmacies, and healthcare providers globally.
Market dynamics and potential entrants
Entry barriers include patent protection, regulatory approval of generics, and manufacturing scale. Competitors targeting MS drugs have yet to develop or seek approval for generic teriflunomide.
Regulatory status
- FDA: Approved for relapsing MS.
- EMA: Approved with similar indications.
- No approved generic versions as of 2023.
Summary
- Manufacturer: Sanofi
- Main product: Aubagio (teriflunomide)
- Patent protection: Until approximately 2030
- Generic availability: None approved or marketed
- Supply chain: Sanofi's internal production, distribution via authorized channels
Key Takeaways
- Sanofi is the exclusive supplier of Aubagio globally.
- Patent protections prevent generic competition until at least 2030.
- No third-party or authorized generics are available commercially.
- Distribution is centralized through Sanofi’s global network.
- Future market opportunities depend on patent status and regulatory developments.
Frequently Asked Questions
1. Are there any approved generic versions of Aubagio?
No, no generic versions have received approval as of 2023. Patents held by Sanofi cover the active ingredient and formulation.
2. Can other companies manufacture teriflunomide?
Only with licensing or patent licensing from Sanofi. No independent manufacturing or approval exists outside Sanofi’s control.
3. When will generics for Aubagio likely enter the market?
Expected around 2029–2030, pending patent expiry and absence of patent litigation or extension.
4. How does the patent landscape affect supply?
Patent protections restrict entry of competitors, ensuring Sanofi remains the sole supplier until patents expire or are invalidated.
5. Are there alternative MS treatments from other suppliers?
Yes, multiple MS drugs are marketed by various companies, but none are bioequivalent to Aubagio.
References
- U.S. Patent No. 8,464,498; No. 8,868,121; No. 9,138,350.
