Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 9, 2019

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IMITREX Drug Profile

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When do Imitrex patents expire, and when can generic versions of Imitrex launch?

Imitrex is a drug marketed by Glaxosmithkline and is included in three NDAs.

The generic ingredient in IMITREX is sumatriptan. There are twenty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.

Drug patent expirations by year for IMITREX
Drug Prices for IMITREX

See drug prices for IMITREX

Drug Sales Revenue Trends for IMITREX

See drug sales revenues for IMITREX

Recent Clinical Trials for IMITREX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Kimberly-Clark CorporationPhase 1
SNBL Clinical Pharmacology Center, Inc.Phase 1
CoLucid PharmaceuticalsPhase 1

See all IMITREX clinical trials

Recent Litigation for IMITREX

Identify potential future generic entrants

District Court Litigation
Case NameDate
Glaxo Group Ltd. v. Spectrum Pharmaceuticals Inc2006-09-08

See all IMITREX litigation

Synonyms for IMITREX
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 (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
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 IMITREX
Tradename Dosage Ingredient NDA Submissiondate
IMITREX TABLET;ORAL sumatriptan succinate 020132

US Patents and Regulatory Information for IMITREX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline IMITREX sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-001 Dec 28, 1992 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-002 Feb 1, 2006 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-002 Aug 26, 1997 DISCN No No   Start Trial   Start Trial   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 IMITREX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-002 Jun 1, 1995   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-002 Jun 1, 1995   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-002 Aug 26, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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