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Details for Generic Name: sumatriptan succinate

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Sumatriptan succinate is the generic ingredient in eight branded drugs marketed by Teva Pharms Usa, Injectalia, Sagent Strides, Teva Parenteral, Antares Pharma Inc, Mylan Labs Ltd, Bedford, Dr Reddys Labs Ltd, Aurobindo Pharma, Par Pharm, Glaxosmithkline, Watson Labs, Endo Ventures Ltd, Fresenius Kabi Usa, Teva, Sagent Agila, Roxane, Mylan, Dr Reddys Labs Inc, Sun Pharm Inds Ltd, Aurobindo Pharma Ltd, Sun Pharma Global, Apotex Inc, Sandoz, Par Sterile Products, Meridian Medcl, Teva Branded Pharm, Hikma Farmaceutica, Orchid Hlthcare, Wockhardt, Sun Pharm Inds, Hikma Pharms, and Avanir Pharms, and is included in thirty-nine 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.

This ingredient has two hundred and ten patent family members in thirty-three 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:8
Patents:23
Applicants:33
NDAs:39
Drug Master File Entries: see list23
Suppliers / Packaging: see list41

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

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

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

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
Aurobindo Pharma
SUMATRIPTAN SUCCINATE
sumatriptan succinate
TABLET;ORAL078327-001Aug 10, 2009RXNo<disabled><disabled>
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 2009RXYes5,957,886<disabled>Y <disabled>
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-002Nov 26, 2013RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: sumatriptan succinate

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
IMITREX
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-001Dec 28, 19925,037,845*PED<disabled>
Glaxosmithkline
IMITREX STATDOSE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-002Feb 1, 20065,037,845*PED<disabled>
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-002Jun 1, 19954,816,470*PED<disabled>
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International Patent Family for Ingredient: sumatriptan succinate

Country Document Number Publication Date
South Africa9703011May 25, 1998
European Patent Office0813431Aug 29, 2001
European Patent Office2073866Oct 05, 2011
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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