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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-four 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

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
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
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS078067-001Feb 6, 2009DISCNNo<disabled><disabled>
Hikma Pharms
sumatriptan succinate
TABLET;ORAL078298-001May 21, 2013RXNo<disabled><disabled>
Endo Ventures Ltd
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 2009RXYes8,241,244<disabled>Y <disabled>
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-002Feb 1, 2006RXYes<disabled><disabled>
Par Pharm
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS077332-001Oct 9, 2009RXNo<disabled><disabled>
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International Patent Family for Ingredient: sumatriptan succinate

Country Document Number Publication Date
Canada2214807Sep 19, 1996
Israel213855Jul 31, 2011
Austria197904Dec 15, 2000
New Zealand593928Mar 28, 2014
JapanH11501549Feb 09, 1999
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Preferred citation:

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

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