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IMITREX STATDOSE Drug Profile
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When do Imitrex Statdose patents expire, and what generic alternatives are available?
Imitrex Statdose is a drug marketed by Glaxosmithkline and is included in one NDA.
The generic ingredient in IMITREX STATDOSE is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
US ANDA Litigation and Generic Entry Outlook for Imitrex Statdose
A generic version of IMITREX STATDOSE was approved as sumatriptan succinate by WEST-WARD PHARMS INT on February 6th, 2009.
Summary for IMITREX STATDOSE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 99 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,370 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for IMITREX STATDOSE |
| DailyMed Link: | IMITREX STATDOSE at DailyMed |
Recent Clinical Trials for IMITREX STATDOSE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 1 |
| GlaxoSmithKline | Phase 4 |
| Diamond Headache Clinic | Phase 4 |
Pharmacology for IMITREX STATDOSE
| Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
| Mechanism of Action | Serotonin 1d Receptor Agonists Serotonin 1b Receptor Agonists |
US Patents and Regulatory Information for IMITREX STATDOSE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | IMITREX STATDOSE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-002 | Feb 1, 2006 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Glaxosmithkline | IMITREX STATDOSE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-003 | Dec 23, 1996 | AB | RX | Yes | Yes | 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 IMITREX STATDOSE
| 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 |
| Glaxosmithkline | IMITREX STATDOSE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-003 | Dec 23, 1996 | Start Trial | Start Trial |
| Glaxosmithkline | IMITREX STATDOSE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 020080-003 | Dec 23, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for IMITREX STATDOSE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Netherlands | 188642 | Start Trial |
| Ireland | 58122 | Start Trial |
| Israel | 75986 | Start Trial |
| Luxembourg | 86032 | Start Trial |
| Italy | 8548435 | Start Trial |
| Egypt | 17283 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
