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Sumatriptan - Generic Drug Details
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What are the generic sources for sumatriptan and what is the scope of freedom to operate?
Sumatriptan
is the generic ingredient in ten branded drugs marketed by Glaxosmithkline, Lannett Co Inc, Upsher Smith Labs, Meridian Medcl, 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, 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 forty-two NDAs. There are forty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Sumatriptan has forty-six patent family members in fourteen countries.
There are twenty-four drug master file entries for sumatriptan. Four suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for sumatriptan
| International Patents: | 46 |
| US Patents: | 44 |
| Tradenames: | 10 |
| Applicants: | 35 |
| NDAs: | 42 |
| Drug Master File Entries: | 24 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 45 |
| Clinical Trials: | 102 |
| Patent Applications: | 6,136 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for sumatriptan |
| Drug Sales Revenues: | Drug sales revenues for sumatriptan |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sumatriptan |
| DailyMed Link: | sumatriptan at DailyMed |
Recent Clinical Trials for sumatriptan
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Avanir Pharmaceuticals | Phase 3 |
| Eli Lilly and Company | Phase 1 |
| Montefiore Medical Center | N/A |
Recent Litigation for sumatriptan
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Glaxo Group Ltd. v. Spectrum Pharmaceuticals Inc | 2006-09-08 |
Generic filers with tentative approvals for SUMATRIPTAN
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 50MG BASE | TABLET;ORAL |
| Start Trial | Start Trial | EQ 25MG BASE | TABLET;ORAL |
| Start Trial | Start Trial | EQ 100MG 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
| Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
| Mechanism of Action | Serotonin 1d Receptor Agonists Serotonin 1b Receptor Agonists |
Medical Subject Heading (MeSH) Categories for sumatriptan
Synonyms for sumatriptan
| (3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl)-N-methylmethanesulfonamide |
| (3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl)-N-methylmethanesulfonamide # |
| 1-(3-(2-(dimethylamino)ethyl)-1H-indol-5-yl)-N-methylmethanesulfonamide |
| 1-[3-(2-dimethylaminoethyl)-1H-indol-5-yl]-N-methyl-methanesulfonamide |
| 1-[3-(2-dimethylaminoethyl)-1H-indol-5-yl]-N-methylmethanesulfonamide |
| 1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]-N-methyl-methanesulfonamide |
| 1-{3-[2-(dimethylamino)ethyl]-1H-indol-5-yl}-N-methylmethanesulfonamide |
| 103628-46-2 |
| 103628-48-4 (succinate) |
| 1H-Indole-5-methanesulfonamide, 3-(2-(dimethylamino)ethyl)-N-methyl- |
| 3-(2-(Dimethylamino)ethyl)-N-methyl-1H-indole-5-methanesulfonamide |
| 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole -5-methanesulphonamide |
| 3-[2-(Dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulfonamide |
| 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulphonamide |
| 3-[2-(Dimethylamino)ethyl]-N-methylindole-5-methanesulfonamide |
| 628S462 |
| 8R78F6L9VO |
| AB0016356 |
| AB00698285_14 |
| AB00698285_15 |
| AB00698285-12 |
| AB00698285-13 |
| AC1L1K6B |
| AJ-08373 |
| AKOS015894924 |
| AN-5271 |
| API0004291 |
| AVP 825 |
| AVP-825 |
| AVP825 |
| BCP02237 |
| BDBM50005835 |
| BIDD:GT0248 |
| BRD-K50938287-001-01-7 |
| BRN 6930870 |
| BSPBio_002304 |
| C07319 |
| C14H21N3O2S |
| CAS-103628-46-2 |
| CCG-230331 |
| CHEBI:10650 |
| CHEMBL128 |
| D00451 |
| DB00669 |
| DSSTox_CID_3628 |
| DSSTox_GSID_23628 |
| DSSTox_RID_77118 |
| DTXSID4023628 |
| FT-0631027 |
| GR 43175 |
| GR 43175X |
| GR-43175 |
| GTPL54 |
| HMS2231B21 |
| HMS3369A05 |
| HSDB 7742 |
| I06-0076 |
| Imigran (TN) |
| Imigran Recovery |
| Imitrex (TN) |
| Imitrex Oral |
| Imitrex, Imigran ,Treximet |
| J-001014 |
| KB-217141 |
| KQKPFRSPSRPDEB-UHFFFAOYSA-N |
| L000584 |
| LS-83175 |
| MCULE-3991948648 |
| MLS001195659 |
| MLS001304742 |
| MolPort-002-885-863 |
| NCGC00095838-01 |
| NCGC00095838-02 |
| NCGC00095838-03 |
| NCGC00095838-04 |
| O262 |
| Onzetra Xsail |
| SBI-0206837.P001 |
| SC-18016 |
| SCHEMBL1482 |
| SMR000596517 |
| SPECTRUM1505372 |
| STL451003 |
| Sumatran |
| Sumatriptan (JAN/USP/INN) |
| Sumatriptan [USP:INN:BAN] |
| Sumatriptanum |
| Sumatriptanum [INN-Latin] |
| Sumax |
| Tox21_111528 |
| Tox21_111528_1 |
| UNII-8R78F6L9VO |
| Zecuity |
| Zembrace SymTouch |
| ZINC14360 |
US Patents and Regulatory Information for sumatriptan
| 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 | 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 | |||
| Currax | ONZETRA XSAIL | sumatriptan succinate | POWDER;NASAL | 206099-001 | Jan 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Teva | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 076840-003 | Feb 9, 2009 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva Branded Pharm | ZECUITY | sumatriptan succinate | SYSTEM;IONTOPHORESIS | 202278-001 | Jan 17, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Y | 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 sumatriptan
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-001 | Aug 26, 1997 | Start Trial | Start Trial |
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | Start Trial | Start Trial |
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-001 | Aug 26, 1997 | Start Trial | Start Trial |
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-002 | Aug 26, 1997 | Start Trial | Start Trial |
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | Start Trial | Start Trial |
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sumatriptan
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2012513412 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011014797 | Start Trial |
| New Zealand | 593782 | Start Trial |
| Australia | 2009329952 | Start Trial |
| Spain | 2553862 | Start Trial |
| Mexico | 338110 | 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 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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.