ONZETRA XSAIL

Peak

sumatriptan succinate

NDANASALPOWDER
Approved
Jan 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6

Mechanism of Action

5-HT 1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition…

Clinical Trials (5)

NCT00875784Phase 1Completed

An Open-label, Randomized, 3-period Crossover Study to Evaluate Sumatriptan Pharmacokinetics for a TREXIMA™ (Sumatriptan Succinate / Naproxen Sodium) Tablet Followed by IMITREX® (Sumatriptan Succinate)

Started May 2008
30 enrolled
Migraine Disorders
NCT00382993Phase 3Completed

A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2)

Started Dec 2006
169 enrolled
Migraine Disorders
NCT00383162Phase 3Completed

A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)

Started Nov 2006
173 enrolled
Migraine Disorders
NCT00356603Phase 3Completed

Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan

Started Jun 2006
75 enrolled
Migraine Disorders
NCT00846885Phase 1Completed

Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions

Started Aug 2004
28 enrolled
Healthy

Loss of Exclusivity

LOE Date
Oct 20, 2034
105 months away
Patent Expiry
Oct 20, 2034

Patent Records (5)

Patent #ExpiryTypeUse Code
11571531
Feb 23, 2026Expired
U-1809
10124132
Mar 6, 2027
Product
U-2011
10398859
Dec 19, 2027
Product
8875704
Apr 7, 2028
Product
U-1809
10722667
Dec 30, 2028
Product