TROKENDI XR

LOE Approaching

topiramate

NDAORALCAPSULE, EXTENDED RELEASE
Approved
Aug 2013
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20

Mechanism of Action

Cytochrome P450 3A4 Inducers

Clinical Trials (5)

NCT05748483Phase 3Active Not Recruiting

Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine

Started Oct 2023
545 enrolled
Migraine
NCT03828539Phase 4Completed

Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine

Started Feb 2019
777 enrolled
Migraine
NCT03335163Phase 1Completed

The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

Started Mar 2018
48 enrolled
MigraineMigraine;MenstrualContraception
NCT03308669Phase 1Completed

A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate

Started Oct 2017
30 enrolled
Healthy
NCT02201251Phase 3Completed

A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy

Started Oct 2014
63 enrolled
Epilepsy

Loss of Exclusivity

LOE Date
Apr 4, 2028
25 months away
Patent Expiry
Apr 4, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
9622983
Nov 16, 2027
Product
U-1675
10314790
Nov 16, 2027
Product
U-1992
8298580
Nov 16, 2027
Product
U-106
8663683
Nov 16, 2027
Product
U-1992
8877248
Nov 16, 2027
Product
U-1992