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Generated: September 17, 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 sumatriptan succinate patent protection?

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, Avanir Pharms, 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-six 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-three patent family members in thirty countries.

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

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
Generic filers with tentative approvals for SUMATRIPTAN SUCCINATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 100MG BASETABLET;ORAL
➤ Sign Up➤ Sign UpEQ 50MG BASETABLET;ORAL
➤ Sign Up➤ Sign UpEQ 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.

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
Endo Ventures Ltd SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-002 Nov 26, 2013 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-003 Dec 23, 1996 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hikma Pharms SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 078298-002 May 21, 2013 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Endo Ventures Ltd SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan Labs Ltd SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 203322-001 Apr 14, 2014 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Endo Ventures Ltd SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan Asi SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 090641-001 Jul 28, 2010 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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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 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-003 Jun 1, 1995 ➤ Sign Up ➤ Sign Up
Endo Ventures Ltd SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-002 Jun 1, 1995 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-001 Dec 28, 1992 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-003 Dec 23, 1996 ➤ Sign Up ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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