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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, Aurobindo Pharma Ltd, Bedford, Dr Reddys Labs Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Injectalia, Mylan Labs Ltd, 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, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirty-six NDAs. There are twenty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and thirty-two patent family members in thirty-four countries.

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

Summary for Generic Name: sumatriptan succinate

Tradenames:6
Patents:24
Applicants:30
NDAs:36
Drug Master File Entries: see list23
Suppliers / Packaging: see list41
Formulation / Manufacturing:see details

Pharmacology for Ingredient: sumatriptan succinate

Tentative approvals for SUMATRIPTAN SUCCINATE

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

Clinical Trials for: sumatriptan succinate

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

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

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

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

Courtesy of ClinicalTrials.org
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
Orchid Hlthcare
SUMATRIPTAN SUCCINATE
sumatriptan succinate
TABLET;ORAL078284-003Aug 10, 2009RXNo<disabled><disabled>
Glaxosmithkline
IMITREX STATDOSE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-003Dec 23, 1996RXYes<disabled><disabled>
Mylan
SUMATRIPTAN SUCCINATE
sumatriptan succinate
TABLET;ORAL077744-003Aug 10, 2009RXNo<disabled><disabled>
Teva Branded Pharm
ZECUITY
sumatriptan succinate
SYSTEM;IONTOPHORESIS202278-001Jan 17, 2013RXYes8,155,737<disabled><disabled>
Injectalia
SUMATRIPTAN SUCCINATE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS090310-001Aug 11, 2010RXNo<disabled><disabled>
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International Patent Family for Ingredient: sumatriptan succinate

Country Document Number Publication Date
Canada2167586Feb 09, 1995
Japan2006513768Apr 27, 2006
Mexico9704576Jul 31, 1998
European Patent Office1097727Apr 10, 2002
European Patent Office1180046Feb 20, 2002
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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