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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 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 forty 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 sixteen patent family members in thirty countries.
There are twenty-four drug master file entries for sumatriptan succinate. Thirty-one suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for sumatriptan succinate
International Patents: | 416 |
US Patents: | 40 |
Tradenames: | 8 |
Applicants: | 34 |
NDAs: | 39 |
Drug Master File Entries: | 24 |
Suppliers / Packagers: | 31 |
Bulk Api Vendors: | 102 |
Clinical Trials: | 21 |
Patent Applications: | 2,159 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for sumatriptan succinate |
Drug Sales Revenues: | Drug sales revenues for sumatriptan succinate |
What excipients (inactive ingredients) are in sumatriptan succinate? | sumatriptan succinate excipients list |
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 |
Cady, Roger, M.D. | Phase 4 |
GlaxoSmithKline | Phase 4 |
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-003 | Jun 1, 1995 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-002 | Jun 1, 1995 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Teva Parenteral | SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 078318-002 | Feb 6, 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 STATDOSE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-002 | Feb 1, 2006 | 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sumatriptan succinate
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2012071175 | Start Trial |
Japan | 2005500877 | Start Trial |
China | 1217712 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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