SUMATRIPTAN - Generic Drug Details
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What are the generic sources for sumatriptan and what is the scope of patent protection?
Sumatriptan
is the generic ingredient in ten branded drugs marketed by Glaxosmithkline, Cipla, Florida, Lannett Co Inc, Padagis Israel, Tonix Meds, Meridian Medcl, Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Sandoz, Steriscience, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Currax, Teva Branded Pharm, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in forty-seven 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 has ninety-one patent family members in twenty-nine countries.
There are twenty-four drug master file entries for sumatriptan. Ten suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for SUMATRIPTAN
International Patents: | 91 |
US Patents: | 39 |
Tradenames: | 10 |
Applicants: | 38 |
NDAs: | 47 |
Drug Master File Entries: | 24 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 70 |
Clinical Trials: | 115 |
Patent Applications: | 6,169 |
Drug Prices: | Drug price trends for SUMATRIPTAN |
Drug Sales Revenues: | Drug sales revenues for SUMATRIPTAN |
What excipients (inactive ingredients) are in SUMATRIPTAN? | SUMATRIPTAN excipients list |
DailyMed Link: | SUMATRIPTAN at DailyMed |
Recent Clinical Trials for SUMATRIPTAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Radboud University Medical Center | Phase 2 |
Canisius-Wilhelmina Hospital | Phase 2 |
Leiden University Medical Center | Phase 2 |
Generic filers with tentative approvals for SUMATRIPTAN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 100MG BASE | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 50MG BASE | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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
Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Medical Subject Heading (MeSH) Categories for SUMATRIPTAN
Anatomical Therapeutic Chemical (ATC) Classes for SUMATRIPTAN
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Watson Labs | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 076933-002 | Aug 10, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Branded Pharm | ZECUITY | sumatriptan succinate | SYSTEM;IONTOPHORESIS | 202278-001 | Jan 17, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Tonix Meds | TOSYMRA | sumatriptan | SPRAY;NASAL | 210884-001 | Jan 25, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Tonix Meds | TOSYMRA | sumatriptan | SPRAY;NASAL | 210884-001 | Jan 25, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Hikma | SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 200183-001 | Sep 16, 2013 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Steriscience | SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 090314-001 | Jun 10, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Antares Pharma Inc | SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 078319-002 | Dec 10, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-001 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-002 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for SUMATRIPTAN
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Galpharm Healthcare Ltd. | Sumatriptan Galpharm | sumatriptan | EMEA/H/C/002140 |
Refused | yes | no | no | 2012-02-09 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for SUMATRIPTAN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20200121818 | 비강내 에피네프린 제제 및 질환의 치료 방법 | ⤷ Sign Up |
Denmark | 2381773 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2011014797 | ⤷ Sign Up | |
Mexico | 2011006790 | COMPOSICIONES PARA ADMINISTRACION DE FARMACOS. (COMPOSITIONS FOR DRUG ADMINISTRATION.) | ⤷ Sign Up |
South Korea | 101646079 | ⤷ Sign Up | |
Mexico | 2012003519 | FORMULACIONES QUE COMPRENDEN COMPUESTOS DE TRIPTANO. (FORMULATIONS COMPRISING TRIPTAN COMPOUNDS.) | ⤷ Sign Up |
Russian Federation | 2011130526 | КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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