Sumatriptan succinate - Generic Drug Details
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What are the generic drug 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, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, Steriscience, 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, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in forty 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 succinate has four hundred and nineteen patent family members in thirty-one countries.
There are seventeen 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: | 419 |
US Patents: | 39 |
Tradenames: | 8 |
Applicants: | 35 |
NDAs: | 40 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 32 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 26 |
Patent Applications: | 3,921 |
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 |
---|---|
The Second Affiliated Hospital of Kunming Medical University | Phase 3 |
Second Hospital of Jilin University | Phase 3 |
Beijing Friendship Hospital | Phase 3 |
Generic filers with tentative approvals for SUMATRIPTAN SUCCINATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | EQ 100MG BASE | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | EQ 50MG BASE | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | 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 1b Receptor Agonists Serotonin 1d Receptor Agonists |
US Patents and Regulatory Information for sumatriptan succinate
Expired US Patents for sumatriptan succinate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Endo Ventures Ltd | SUMAVEL DOSEPRO | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 022239-001 | Jul 15, 2009 | See Plans and Pricing | See Plans and Pricing |
Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-002 | Jun 1, 1995 | See Plans and Pricing | See Plans and Pricing |
Endo Ventures Ltd | SUMAVEL DOSEPRO | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 022239-001 | Jul 15, 2009 | See Plans and Pricing | See Plans and Pricing |
Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-001 | Jun 1, 1995 | See Plans and Pricing | See Plans and Pricing |
Glaxosmithkline | IMITREX | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-001 | Dec 28, 1992 | See Plans and Pricing | See Plans and Pricing |
Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-001 | Jun 1, 1995 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sumatriptan succinate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4688416 | See Plans and Pricing | |
Japan | 2011524901 | See Plans and Pricing | |
Canada | 2727927 | PHARMACOCINETIQUE D'UNE ADMINISTRATION IONTOPHORETIQUE DE SUMATRIPTAN (PHARMACOKINETICS OF IONTOPHORETIC SUMATRIPTAN ADMINISTRATION) | See Plans and Pricing |
Japan | 4959906 | See Plans and Pricing | |
European Patent Office | 2136865 | ADMINISTRATION NASALE (NASAL DELIVERY) | See Plans and Pricing |
Canada | 2918226 | DISPOSITIF D'ADMINISTRATION NASALE SERVANT A ADMINISTRER UNE SUBSTANCE DANS UNE CAVITE NASALE D'UN SUJET (NASAL DELIVERY DEVICE FOR DELIVERING SUBSTANCE TO A NASAL CAVITY OF A SUBJECT) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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