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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 patent protection?
Sumatriptan
is the generic ingredient in ten branded drugs marketed by Glaxosmithkline, Lannett Co Inc, Perrigo Uk Finco, 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, 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 forty-four NDAs. There are forty-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Sumatriptan has sixty-one patent family members in nineteen countries.
There are twenty-four drug master file entries for sumatriptan. Six suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for sumatriptan
International Patents: | 61 |
US Patents: | 47 |
Tradenames: | 10 |
Applicants: | 36 |
NDAs: | 44 |
Drug Master File Entries: | 24 |
Suppliers / Packagers: | 6 |
Bulk Api Vendors: | 48 |
Clinical Trials: | 106 |
Patent Applications: | 5,517 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for sumatriptan |
Drug Sales Revenues: | Drug sales revenues for sumatriptan |
DailyMed Link: | sumatriptan at DailyMed |
Recent Clinical Trials for sumatriptan
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cambridge University Hospitals NHS Foundation Trust | Early Phase 1 |
Pfizer | Phase 1 |
Zagazig University | N/A |
Generic filers with tentative approvals for SUMATRIPTAN
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
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
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 | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 076840-002 | Feb 9, 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 | |||
Upsher Smith Labs | ZEMBRACE SYMTOUCH | sumatriptan succinate | SOLUTION;SUBCUTANEOUS | 208223-001 | Jan 28, 2016 | RX | Yes | 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 | |||
Hikma Pharms | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078298-003 | May 21, 2013 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Fresenius Kabi Usa | SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 079240-001 | Sep 18, 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
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 |
---|---|---|
Israel | 276485 | Start Trial |
World Intellectual Property Organization (WIPO) | 2011014797 | Start Trial |
United Kingdom | 202012086 | Start Trial |
South Africa | 201202168 | Start Trial |
Canada | 3088989 | Start Trial |
Canada | 2748268 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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