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Generated: April 19, 2018

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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 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 Labs Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Injectalia, Mylan Asi, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, Sun Pharma Global, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Endo Ventures Ltd, Avanir Pharms, Dr Reddys Labs Ltd, Teva Branded Pharm, Apotex Inc, Aurobindo Pharma, 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-three 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 seventy-six patent family members in thirty countries.

There are twenty-four drug master file entries for sumatriptan succinate. Forty-five suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for sumatriptan succinate
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-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-?METHYL-?1H-?INDOLE-?5-?METHANESULFONAMIDE-?BUTANEDIOIC ACID
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
AK-56079
AKOS015900409
Alsuma
Alsuma (TN)
AN-1097
Antibet
API0009779
Arcoiran
AX8017360
BC208270
BG0326
Butanedioic acid, compd. with 3-(2-(dimethylamino)ethyl)-N-methyl-1H-indole-5-methanesulfonamide (1:1)
BUTANEDIOIC ACID, COMPOUND 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 43175C
GR-43175 SUCCINATE
GR-43175C
H689
HE274835
HE301771
HMS2051H04
HMS2090G21
HMS2231K14
HMS3370G19
HMS3393H04
HMS3651E11
HY-B0121
I14-0769
Imigran
Imigran;mitrex;Imitrex;Suminat;Sumitrex
Imigrane
Imijekt
Imitrex
Imitrex Statdose
J8BDZ68989
Jsp000369
KB-217142
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
ST24026862
ST51053944
SUCCINIC ACID-1-(3-[2-(DIMETHYLAMINO)ETHYL]-1H-INDOL-5-YL)-N-METHYLMETHANESULFONAMIDE (1:1)
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
TL8000157
TO-303S
UNII-J8BDZ68989
Z1551429732
Zecutity (TN)
Zelrix
Zembrace SymTouch
Tentative approvals for SUMATRIPTAN SUCCINATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free TrialEQ 25MG BASETABLET;ORAL
➤ Try a Free Trial➤ Try a Free TrialEQ 100MG BASETABLET;ORAL
➤ Try a Free Trial➤ Try a Free TrialEQ 50MG BASETABLET;ORAL

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
Dr Reddys Labs Inc SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 090495-001 Jan 29, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Avanir Pharms ONZETRA XSAIL sumatriptan succinate POWDER;INHALATION 206099-001 Jan 27, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 200263-001 Jun 19, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Avanir Pharms ONZETRA XSAIL sumatriptan succinate POWDER;INHALATION 206099-001 Jan 27, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-002 Feb 1, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-003 Dec 23, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-003 Jun 1, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-003 Dec 23, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for sumatriptan succinate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,629,960 Needleless injector ➤ Try a Free Trial
8,555,878 Nasal delivery device ➤ Try a Free Trial
8,596,278 Nasal devices ➤ Try a Free Trial
8,663,158 Needleless injector drug capsule and a method for filling thereof ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Cipla
Federal Trade Commission
Baxter
Moodys
UBS
Citi
McKinsey
Dow

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