NDAORALTABLET1 Generic Approved
Approved
Sep 2012
Lifecycle
Peak
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
AUBAGIO (teriflunomide) by Sanofi is dihydroorotate dehydrogenase inhibitors [moa]. Approved for pyrimidine synthesis inhibitor [epc]. First approved in 2012.
Drug data last refreshed 1h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUBAGIO (teriflunomide) is an oral small-molecule pyrimidine synthesis inhibitor that reduces immune cell proliferation by blocking dihydroorotate dehydrogenase. It is approved for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive MS. The drug works by selectively inhibiting a key enzyme in the de novo pyrimidine synthesis pathway, thereby suppressing T and B cell proliferation.
$0.354BPart D
Peak7.9 years to LOEMature product at peak sales with stable Medicare utilization; brand team likely focused on defending market share against competitive erosion rather than expansion.
Mechanism of Action
Dihydroorotate Dehydrogenase Inhibitors
Pharmacologic Class:
Pyrimidine Synthesis Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1)
Started Dec 2021
1,000 enrolled
Relapsing Multiple Sclerosis
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)
Started Dec 2021
1,007 enrolled
Relapsing Multiple Sclerosis
An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis
Started Apr 2021
336 enrolled
Multiple Sclerosis
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Started Mar 2021
751 enrolled
Relapsing Multiple Sclerosis
Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients Treated With Teriflunomide and Alemtuzumab
Started Mar 2021
70 enrolled
Multiple Sclerosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.