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ISRADIPINE Drug Profile
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Which patents cover Isradipine, and when can generic versions of Isradipine launch?
Isradipine is a drug marketed by Elite Labs Inc, Watson Labs Teva, and Mylan. and is included in three NDAs.
The generic ingredient in ISRADIPINE is isradipine. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the isradipine profile page.
US ANDA Litigation and Generic Entry Outlook for Isradipine
A generic version of ISRADIPINE was approved as isradipine by WATSON LABS TEVA on January 5th, 2006.
Summary for ISRADIPINE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 89 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,236 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ISRADIPINE |
| DailyMed Link: | ISRADIPINE at DailyMed |
Recent Clinical Trials for ISRADIPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Texas at Austin | Early Phase 1 |
| National Institute of Neurological Disorders and Stroke (NINDS) | Phase 3 |
| The Parkinson Study Group | Phase 3 |
Pharmacology for ISRADIPINE
| Drug Class | Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for ISRADIPINE
US Patents and Regulatory Information for ISRADIPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Elite Labs Inc | ISRADIPINE | isradipine | CAPSULE;ORAL | 077169-001 | Apr 24, 2006 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Watson Labs Teva | ISRADIPINE | isradipine | CAPSULE;ORAL | 077317-002 | Jan 5, 2006 | AB | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Elite Labs Inc | ISRADIPINE | isradipine | CAPSULE;ORAL | 077169-002 | Apr 24, 2006 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Watson Labs Teva | ISRADIPINE | isradipine | CAPSULE;ORAL | 077317-001 | Jan 5, 2006 | AB | RX | 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 |
