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IMITREX STATDOSE Drug Profile
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Which patents cover Imitrex Statdose, and when can generic versions of Imitrex Statdose launch?
Imitrex Statdose is a drug marketed by Glaxosmithkline and is included in one NDA.
The generic ingredient in IMITREX STATDOSE is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
US ANDA Litigation and Generic Entry Outlook for Imitrex Statdose
A generic version of IMITREX STATDOSE was approved as sumatriptan succinate by TEVA PHARMS USA on January 17th, 2020.
Summary for IMITREX STATDOSE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 92 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,342 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for IMITREX STATDOSE |
| DailyMed Link: | IMITREX STATDOSE at DailyMed |
Recent Clinical Trials for IMITREX STATDOSE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 1 |
| Diamond Headache Clinic | Phase 4 |
| GlaxoSmithKline | Phase 4 |
Pharmacology for IMITREX STATDOSE
| Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
| Mechanism of Action | Serotonin 1d Receptor Agonists Serotonin 1b Receptor Agonists |
Synonyms for IMITREX STATDOSE
| 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) |
| 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 |
US Patents and Regulatory Information for IMITREX STATDOSE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | IMITREX STATDOSE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-002 | Feb 1, 2006 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Glaxosmithkline | IMITREX STATDOSE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-003 | Dec 23, 1996 | AB | RX | Yes | Yes | 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 STATDOSE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | IMITREX STATDOSE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-002 | Feb 1, 2006 | Start Trial | Start Trial |
| Glaxosmithkline | IMITREX STATDOSE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-003 | Dec 23, 1996 | Start Trial | Start Trial |
| Glaxosmithkline | IMITREX STATDOSE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-003 | Dec 23, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
