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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
| International Patents: | 376 |
| US Patents: | 33 |
| Tradenames: | 8 |
| Applicants: | 33 |
| NDAs: | 39 |
| Drug Master File Entries: | 24 |
| Suppliers / Packagers: | 45 |
| Bulk Api Vendors: | 81 |
| 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 25MG BASE | TABLET;ORAL |
| ➤ 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 |
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 | ➤ Try a Free Trial | ||||
| Fosun Pharma | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 076976-002 | Aug 10, 2009 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Mylan | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 077163-001 | Nov 2, 2009 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ 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 |
|---|---|---|---|---|---|---|---|
| Endo Ventures Ltd | SUMAVEL DOSEPRO | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 022239-001 | Jul 15, 2009 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-002 | Jun 1, 1995 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Glaxosmithkline | IMITREX | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-001 | Dec 28, 1992 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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 |
|---|---|---|
| 8,663,158 | Needleless injector drug capsule and a method for filling thereof | ➤ Try a Free Trial |
| 9,138,538 | Device for readying a needle free injector for delivery | ➤ Try a Free Trial |
| 9,629,960 | Needleless injector | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for sumatriptan succinate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Australia | 2008358027 | ➤ Try a Free Trial |
| China | 103228318 | ➤ Try a Free Trial |
| European Patent Office | 1363691 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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