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Sumatriptan succinate - Generic Drug Details
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This ingredient has four hundred and fifty patent family members in thirty-seven countries.
There are twenty-three drug master file entries for sumatriptan succinate. Forty-six suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for Generic Name: sumatriptan succinate
| Tradenames: | 8 |
| Patents: | 37 |
| Applicants: | 33 |
| NDAs: | 39 |
| Drug Master File Entries: see list | 23 |
| Suppliers / Packaging: see list | 46 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: sumatriptan succinate
| Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Tentative approvals for SUMATRIPTAN SUCCINATE
| Applicant | Application No. | Form | Dosage |
| <disabled> | <disabled> | TABLET; ORAL | 25MG |
| <disabled> | <disabled> | TABLET; ORAL | 50MG |
| <disabled> | <disabled> | TABLET; ORAL | 100MG |
Clinical Trials for: sumatriptan succinate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Inds | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078295-002 | Aug 10, 2009 | RX | No | ||||||||||||||||||||||
Endo Ventures Ltd | SUMAVEL DOSEPRO | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 022239-001 | Jul 15, 2009 | RX | Yes | 8,343,130 | Oct 18, 2022 | Y | |||||||||||||||||||
Endo Ventures Ltd | SUMAVEL DOSEPRO | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 022239-001 | Jul 15, 2009 | RX | Yes | 7,901,385 | Jul 31, 2026 | Y | |||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: sumatriptan succinate
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-002 | Jun 1, 1995 | 5,037,845*PED | <disabled> | ||||||||||||||||||||||
Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-002 | Jun 1, 1995 | 5,863,559*PED | <disabled> | ||||||||||||||||||||||
Endo Ventures Ltd | SUMAVEL DOSEPRO | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 022239-001 | Jul 15, 2009 | 5,957,886 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: sumatriptan succinate
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,740,014 | Nasal devices | <disabled in preview> | |||||||||||||||||||||||||||
| 8,715,259 | Casing | <disabled in preview> | |||||||||||||||||||||||||||
| 9,072,857 | Nasal delivery device | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Ingredient: sumatriptan succinate
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2002302868 | <disabled in preview> | |||||||||||||||||||||||||||
| China | 1736502 | <disabled in preview> | |||||||||||||||||||||||||||
| Canada | 2918226 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
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