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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 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, 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, Apotex Inc, Aurobindo Pharma, 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-seven 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 ninety-four 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: | 394 |
| US Patents: | 37 |
| Tradenames: | 8 |
| Applicants: | 34 |
| NDAs: | 39 |
| Drug Master File Entries: | 24 |
| Suppliers / Packagers: | 32 |
| Bulk Api Vendors: | 92 |
| 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-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) |
| 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 (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 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roxane | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078241-001 | Aug 10, 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 | |||
| Currax | ONZETRA XSAIL | sumatriptan succinate | POWDER;NASAL | 206099-001 | Jan 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-001 | Jun 1, 1995 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Fosun Pharma | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 076976-003 | Aug 10, 2009 | 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 sumatriptan succinate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-003 | Jun 1, 1995 | Start Trial | Start Trial |
| Endo Ventures Ltd | SUMAVEL DOSEPRO | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 022239-001 | Jul 15, 2009 | Start Trial | Start Trial |
| Endo Ventures Ltd | SUMAVEL DOSEPRO | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 022239-001 | Jul 15, 2009 | Start Trial | Start Trial |
| Glaxosmithkline | IMITREX | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-001 | Dec 28, 1992 | Start Trial | Start Trial |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-001 | Jun 1, 1995 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sumatriptan succinate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| United Kingdom | 0114272 | Start Trial |
| Eurasian Patent Organization | 026988 | Start Trial |
| Spain | 2526118 | Start Trial |
| Canada | 2727926 | Start Trial |
| Japan | 2009034534 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.