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Details for Generic Name: sumatriptan succinate

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Sumatriptan succinate is the generic ingredient in six branded drugs marketed by Meridian Medcl, Glaxosmithkline, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Dr Reddys Labs Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Injectalia, Par Pharm, Par Sterile Products, Sagent Agila, Sagent Strides, Sandoz, Sun Pharma Global, Teva Parenteral, Teva Pharms Usa, Wockhardt, Endo Ventures Ltd, Teva Branded Pharm, Apotex Inc, Aurobindo Pharma, Hikma Pharms, Mylan, Orchid Hlthcare, Ranbaxy, Roxane, Sun Pharm Inds, Teva, and Watson Labs, and is included in thirty-six NDAs. There are twenty-three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for sumatriptan succinate. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: sumatriptan succinate

Drug Master File Entries: see list23
Suppliers: see list10

Pharmacology for Ingredient: sumatriptan succinate

Tentative approvals for SUMATRIPTAN SUCCINATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL50MG
<disabled><disabled>TABLET; ORAL100MG
<disabled><disabled>TABLET; ORAL25MG

Clinical Trials for: sumatriptan succinate

A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period
Status: Completed Condition: Migraine With or Without Aura; Migraine Disorders; Migraine, Acute; Migraine Headaches

Bioavailability Study to Compare OPTINOSE SUMATRIPTAN With IMITREX® in Healthy Subjects
Status: Completed Condition: Migraine

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)
Status: Completed Condition: Migraine With or Without Aura; Migraine Disorders; Cluster Headache; Migraine

Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions
Status: Completed Condition: Healthy

Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
Status: Completed Condition: Migraine Disorders; Cluster Headache; Migraine

Sumatriptan as Treatment for Post-traumatic Headache
Status: Recruiting Condition: Post-traumatic Headache

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sagent Strides
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS090314Jun 10, 2010RXNo<disabled><disabled>
Endo Ventures Ltd
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239Jul 15, 2009RXYes6,681,810<disabled>Y<disabled>
Teva Branded Pharm
sumatriptan succinate
SYSTEM;IONTOPHORESIS202278Jan 17, 2013RXYes7,973,058<disabled><disabled>
Watson Labs
sumatriptan succinate
TABLET;ORAL076933Aug 10, 2009RXNo<disabled><disabled>
Sagent Agila
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS090641Jul 28, 2010RXNo<disabled><disabled>
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