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Last Updated: November 16, 2019

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Sumatriptan succinate - Generic Drug Details

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What are the generic sources for sumatriptan succinate and what is the scope of freedom to operate?

Sumatriptan succinate is the generic ingredient in eight branded drugs marketed by Meridian Medcl, Glaxosmithkline, Antares Pharma Inc, Aurobindo Pharma Ltd, Dr Reddys, Fresenius Kabi Usa, Hikma, Mylan Asi, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Endo Ventures Ltd, Currax, Upsher Smith Labs, Teva Branded Pharm, Apotex Inc, Aurobindo Pharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orchid Hlthcare, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirty-nine NDAs. There are thirty-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan succinate has three hundred and ninety-four patent family members in thirty countries.

There are twenty-four drug master file entries for sumatriptan succinate. Thirty-one suppliers are listed for this compound. There are four tentative approvals for this compound.

Drug Prices for sumatriptan succinate

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Drug Sales Revenue Trends for sumatriptan succinate

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Recent Clinical Trials for sumatriptan succinate

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SponsorPhase
Kimberly-Clark CorporationPhase 1
GlaxoSmithKlinePhase 4
Cady, Roger, M.D.Phase 4

See all sumatriptan succinate clinical trials

Recent Litigation for sumatriptan succinate

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District Court Litigation
Case NameDate
ADAMAS PHARMA, LLC v. SANDOZ INC.2018-05-10
Glaxo Group Ltd. v. Spectrum Pharmaceuticals Inc2006-09-08

See all sumatriptan succinate litigation

Generic filers with tentative approvals for SUMATRIPTAN SUCCINATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 100MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 50MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 25MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Synonyms for sumatriptan succinate
1-(3-(2-(Dimethylamino)ethyl)-1H-indol-5-yl)-N-methylmethanesulfonamide succinate
1-[3-(2-DIMETHYLAMINOETHYL)-1H-INDOL-5-YL]-N-METHYL-METHANESULFONAMIDE SUCCINATE
1-[3-(2-dimethylaminoethyl)-1h-indol-5-yl]-n-methylmethanesulfonamide succinate
1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]-N-methyl-methanesulfonamide; succinic acid
1-{3-[2-(dimethylamino)ethyl]-1H-indol-5-yl}-N-methylmethanesulfonamide butanedioate
1-{3-[2-(dimethylamino)ethyl]-1h-indol-5-yl}-n-methylmethanesulfonamide succinate
1-{3-[2-(dimethylamino)ethyl]-1H-indol-5-yl}-N-methylmethanesulfonamide; butanedioic acid
103628-46-2 (Parent)
103628-48-4
1H-Indole-5-methanesulfonamide, 3-(2-(dimethylamino)ethyl)-N-methyl-, butanedioate (1:1)
3-(2-(Dimethylamino)ethyl)-N-methylindole-5-methanesulfonamide succinate
3-(2-(Dimethylamino)ethyl)-N-methylindole-5-methanesulfonamide succinate (1:1)
3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl-N-methylmethanesulfonamide Succinate
3-[2-(DIMETHYLAMINO)ETHYL]-N-METHYL-1H-INDOLE-5-METHANESULFONAMIDE SUCCINATE
3-[2-(Dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulfonamide,butanedioate(1:1)
628S484
A800771
AB0013192
AB07670
AB2000103
AC-751
AC1L1RX2
AC1Q5VRF
AKOS015900409
Alsuma
Alsuma (TN)
AN-1097
Antibet
API0009779
Arcoiran
AX8017360
BC208270
BCP05168
BG0326
Butanedioic acid, compd. with 3-(2-(dimethylamino)ethyl)-N-methyl-1H-indole-5-methanesulfonamide (1:1)
butanedioic acid; 1-[3-(2-dimethylaminoethyl)-1H-indol-5-yl]-N-methylmethanesulfonamide
butanedioic acid; 1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]-N-methyl-methanesulfonamide
butanedioic acid; 1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide
butanedioic acid;1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide
C14H21N3O2S.C4H6O4
C18H27N3O6S
CCG-100994
CHEBI:64359
CHEMBL1201150
CPD000469158
CS-1884
CTK8F0759
D00676
Diletan
DTXSID60145966
F0001-2411
FT-0651836
GR 43175
GR 43175; GW 102; SN 308
GR 43175C
GR-43175C
H689
HMS2051H04
HMS2090G21
HMS2231K14
HMS3370G19
HMS3393H04
HMS3651E11
HMS3714G05
HY-B0121
I14-0769
Imigran
Imigran;mitrex;Imitrex;Suminat;Sumitrex
Imigrane
Imijekt
Imitrex
Imitrex (TN)
Imitrex Statdose
J8BDZ68989
Jsp000369
KB-217142
KS-1116
LS-45735
MFCD00902856
Micralgin
Migmax
Migratan
Migratriptan
mitrex
MLS001401405
MLS006011969
MolPort-003-850-372
N,N-dimethyl-2-{5-[(methylsulfamoyl)methyl]-1H-indol-3-yl}ethanaminium 3-carboxypropanoate
NC00244
Novelian
NSC-760362
NSC760362
Onzetra Xsail
Permicran
Pharmakon1600-01505372
PORMUFZNYQJOEI-UHFFFAOYSA-N
Q-201772
RT-015829
S0851
s1432
SAM001246579
SC-19151
SCHEMBL41674
SMR000469158
SN-308
SR-01000763688
SR-01000763688-4
ST24026862
succinic acid; sumatriptan
Sumadol
Sumatrin
Sumatriptan (succinate)
Sumatriptan for system suitability, European Pharmacopoeia (EP) Reference Standard
sumatriptan hydrogen succinate
Sumatriptan SDI
Sumatriptan succinate (JAN/USAN)
Sumatriptan succinate [USAN]
Sumatriptan succinate, >=98% (HPLC), solid
Sumatriptan succinate, European Pharmacopoeia (EP) Reference Standard
Sumatriptan succinate, United States Pharmacopeia (USP) Reference Standard
Sumave dosepro (TN)
Sumavel DosePro
Sumigrene
Suminat
Sumitrex
SW197624-3
TL8000157
TO-303S
UNII-J8BDZ68989
Z1551429732
Zecutity (TN)
Zelrix
Zembrace SymTouch
Paragraph IV (Patent) Challenges for SUMATRIPTAN SUCCINATE
Tradename Dosage Ingredient NDA Submissiondate
IMITREX TABLET;ORAL sumatriptan succinate 020132

US Patents and Regulatory Information for sumatriptan succinate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Currax ONZETRA XSAIL sumatriptan succinate POWDER;NASAL 206099-001 Jan 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Currax ONZETRA XSAIL sumatriptan succinate POWDER;NASAL 206099-001 Jan 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Watson Labs SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 076933-003 Aug 10, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Currax ONZETRA XSAIL sumatriptan succinate POWDER;NASAL 206099-001 Jan 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for sumatriptan succinate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Ventures Ltd SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-002 Jun 1, 1995   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-003 Jun 1, 1995   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-001 Dec 28, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.