NDASUBCUTANEOUSSOLUTION
Approved
Oct 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
5/8 — Partial
OTREXUP PFS (methotrexate) by Teva is folic acid metabolism inhibitors [moa]. First approved in 2013.
Drug data last refreshed 13h ago · AI intelligence enriched 3mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OTREXUP PFS is a subcutaneous solution formulation of methotrexate, a folic acid metabolism inhibitor used to treat autoimmune and malignant conditions. It works by inhibiting dihydrofolate reductase, disrupting nucleotide synthesis and cellular proliferation. The pre-filled syringe (PFS) format offers improved convenience and dosing accuracy compared to traditional formulations.
Peak4.7 years to LOE
Product is in peak commercial phase with mature market penetration; sales and marketing teams are likely focused on maintaining market share and managing pricing pressures.
Mechanism of Action
Folic Acid Metabolism Inhibitors
Pharmacologic Class:
Folate Analog Metabolic Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Natrunix in Combination With Methotrexate for Rheumatoid Arthritis Treatment
Started Jul 2026
108 enrolled
Rheumatoid Arthritis
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
Started Mar 2026
48 enrolled
Healthy Volunteers
A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
Started Feb 2026
180 enrolled
Active Rheumatoid Arthritis
A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
Started Feb 2026
270 enrolled
Uncontrolled Gout
A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL
Started Dec 2025
77 enrolled
PCNSLPrimary Central Nervous System Lymphoma
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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.