NDAORALTABLET, EXTENDED RELEASE
Approved
Mar 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
TEGRETOL-XR (carbamazepine) by Novartis is cytochrome p450 3a4 inducers [moa]. First approved in 1996.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TEGRETOL-XR (carbamazepine) is an extended-release oral tablet and CYP3A4 inducer used to treat epilepsy, bipolar disorder, and seizures. It functions as a mood stabilizer and anticonvulsant, with a mechanism of action involving inhibition of voltage-gated sodium channels. The drug has been approved since 1996 and remains a foundational therapy across multiple CNS indications.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (score: 30/100); commercial teams are likely focused on cost defense and brand loyalty strategies rather than growth.
Mechanism of Action
Cytochrome P450 3A4 Inducers
Pharmacologic Class:
Mood Stabilizer
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole
Started Apr 2026
28 enrolled
Healthy Participants
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 Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults
Started Feb 2026
54 enrolled
Healthy Volunteer
To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants
Started Dec 2025
36 enrolled
HealthyVolunteer
A Study to Learn if Multiple Doses of the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine PF-07248144
Started Sep 2025
12 enrolled
Healthy Adults
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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.