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Sumatriptan succinate - Generic Drug Details
What are the generic drug 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 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.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
| US Patents: | 33 |
| Tradenames: | 8 |
| Applicants: | 33 |
| NDAs: | 39 |
| Drug Master File Entries: | 24 |
| Suppliers / Packagers: | 45 |
| Bulk Api Vendors: | 80 |
| Clinical Trials: | 21 |
| Patent Applications: | 1,862 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for sumatriptan succinate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sumatriptan succinate |
| DailyMed Link: | sumatriptan succinate at DailyMed |
Pharmacology for sumatriptan succinate
| Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
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 Trial | EQ 100MG BASE | TABLET;ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | EQ 50MG BASE | TABLET;ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | EQ 25MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | ZECUITY | sumatriptan succinate | SYSTEM;IONTOPHORESIS | 202278-001 | Jan 17, 2013 | DISCN | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ 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 | |||
| Teva Branded Pharm | ZECUITY | sumatriptan succinate | SYSTEM;IONTOPHORESIS | 202278-001 | Jan 17, 2013 | DISCN | Yes | No | ➤ 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 |
Expired US Patents for sumatriptan succinate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-001 | 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 |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-003 | Jun 1, 1995 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for sumatriptan succinate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Poland | 203959 | ➤ Try a Free Trial |
| United Kingdom | 0206560 | ➤ Try a Free Trial |
| European Patent Office | 1363692 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
For more information try a trial or see the plans and pricing
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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