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Sumatriptan succinate - Generic Drug Details
What are the generic sources for sumatriptan succinate and what is the scope of 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, Fresenius Kabi Usa, Hikma, Mylan Asi, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Endo Ventures Ltd, Currax, Upsher Smith Labs, Teva Branded Pharm, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, 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-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Sumatriptan succinate has four hundred and ten patent family members in thirty countries.
There are twenty-four drug master file entries for sumatriptan succinate. Thirty-two suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for sumatriptan succinate
| International Patents: | 410 |
| US Patents: | 39 |
| Tradenames: | 8 |
| Applicants: | 34 |
| NDAs: | 39 |
| Drug Master File Entries: | 24 |
| Suppliers / Packagers: | 32 |
| Bulk Api Vendors: | 93 |
| Clinical Trials: | 21 |
| Patent Applications: | 2,034 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for sumatriptan succinate |
| Drug Sales Revenues: | Drug sales revenues for sumatriptan succinate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sumatriptan succinate |
| DailyMed Link: | sumatriptan succinate at DailyMed |
Recent Clinical Trials for sumatriptan succinate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kimberly-Clark Corporation | Phase 1 |
| GlaxoSmithKline | Phase 4 |
| Cady, Roger, M.D. | Phase 4 |
Recent Litigation for sumatriptan succinate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ADAMAS PHARMA, LLC v. SANDOZ INC. | 2018-05-10 |
| Glaxo Group Ltd. v. Spectrum Pharmaceuticals Inc | 2006-09-08 |
Generic filers with tentative approvals for SUMATRIPTAN SUCCINATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 100MG BASE | TABLET;ORAL |
| Start Trial | Start Trial | EQ 50MG BASE | TABLET;ORAL |
| Start Trial | Start Trial | EQ 25MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for sumatriptan succinate
| Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
| Mechanism of Action | Serotonin 1d Receptor Agonists Serotonin 1b Receptor Agonists |
Synonyms for sumatriptan succinate
| 1-(3-(2-(Dimethylamino)ethyl)-1H-indol-5-yl)-N-methylmethanesulfonamide succinate |
| 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 |
| 103628-48-4 |
| 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 SUCCINATE |
| 3-[2-(DiMethylaMino)ethyl]-N-Methyl-1H-indole-5-MethanesulfonaMide,butanedioate |
| 628S484 |
| A800771 |
| AB0013192 |
| AB07670 |
| AB2000103 |
| AC-751 |
| AK-56079 |
| AKOS015900409 |
| Alsuma |
| Alsuma (TN) |
| Antibet |
| API0009779 |
| Arcoiran |
| AX8017360 |
| BCP05168 |
| BG0326 |
| Butanedioic acid, compd. with 3-(2-(dimethylamino)ethyl)-N-methyl-1H-indole-5-methanesulfonamide (1:1) |
| 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 43175C |
| GR-43175C |
| GW 102 |
| H689 |
| HMS2051H04 |
| HMS2090G21 |
| HMS2231K14 |
| HMS3370G19 |
| HMS3393H04 |
| HMS3414A11 |
| HMS3651E11 |
| HMS3678A11 |
| HMS3714G05 |
| HMS3747O17 |
| HY-B0121 |
| Imigran |
| Imigran;mitrex;Imitrex;Suminat;Sumitrex |
| Imigrane |
| Imijekt |
| Imitrex |
| Imitrex (TN) |
| Imitrex Statdose |
| J8BDZ68989 |
| KS-1116 |
| LS-45735 |
| MFCD00902856 |
| Micralgin |
| Migmax |
| Migratan |
| Migratriptan |
| mitrex |
| MLS001401405 |
| MLS006011969 |
| 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 |
| Q10374626 |
| RT-015829 |
| S0851 |
| s1432 |
| SAM001246579 |
| SC-19151 |
| SCHEMBL41674 |
| SMR000469158 |
| SN 308 |
| SN-308 |
| SR-01000763688 |
| SR-01000763688-4 |
| ST24026862 |
| 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 |
| Sumatriptan-succinate |
| Sumave dosepro (TN) |
| Sumavel DosePro |
| Sumigrene |
| Suminat |
| Sumitrex |
| SW197624-3 |
| TO-303S |
| UNII-J8BDZ68989 |
| Z1551429732 |
| Zecutity (TN) |
| Zelrix |
| Zembrace SymTouch |
Paragraph IV (Patent) Challenges for SUMATRIPTAN SUCCINATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| IMITREX | TABLET;ORAL | sumatriptan succinate | 020132 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Sterile Products | SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 077871-001 | Jul 9, 2009 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan Labs Ltd | SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 203322-001 | Apr 14, 2014 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sandoz Inc | SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 078067-001 | Feb 6, 2009 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Currax | ONZETRA XSAIL | sumatriptan succinate | POWDER;NASAL | 206099-001 | Jan 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Mylan | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 077744-003 | Aug 10, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Zydus | SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 090310-001 | Aug 11, 2010 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-003 | Jun 1, 1995 | AB | RX | Yes | 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 sumatriptan succinate
International Patents for sumatriptan succinate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2644269 | Start Trial |
| South Korea | 20010103036 | Start Trial |
| Eurasian Patent Organization | 200802146 | Start Trial |
| Mexico | 358061 | Start Trial |
| Canada | 2935569 | Start Trial |
| European Patent Office | 1853338 | Start Trial |
| Singapore | 11201405179V | Start Trial |
| >Country | >Patent 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 verification 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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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