ISRADIPINE Drug Patent 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. Four suppliers are listed for this compound. Additional details are available on the isradipine profile page.
DrugPatentWatch® 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 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Clinical Trials: | 12 |
| Patent Applications: | 4,359 |
| 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 |
|---|---|
| Menarini International Operations Luxembourg SA | Phase 4 |
| National Institute on Drug Abuse (NIDA) | Early Phase 1 |
| University of Texas at Austin | Early Phase 1 |
Pharmacology for ISRADIPINE
| Drug Class | Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for ISRADIPINE
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Watson Labs Teva | ISRADIPINE | isradipine | CAPSULE;ORAL | 077317-002 | Jan 5, 2006 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Elite Labs Inc | ISRADIPINE | isradipine | CAPSULE;ORAL | 077169-002 | Apr 24, 2006 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Watson Labs Teva | ISRADIPINE | isradipine | CAPSULE;ORAL | 077317-001 | Jan 5, 2006 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan | ISRADIPINE | isradipine | TABLET, EXTENDED RELEASE;ORAL | 201067-002 | Nov 27, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan | ISRADIPINE | isradipine | TABLET, EXTENDED RELEASE;ORAL | 201067-001 | Nov 27, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
