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Isradipine - Generic Drug Details
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What are the generic sources for isradipine and what is the scope of freedom to operate?
Isradipine
is the generic ingredient in three branded drugs marketed by Smithkline Beecham, Elite Labs Inc, Watson Labs Teva, Glaxosmithkline Llc, and Mylan, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for isradipine. Five suppliers are listed for this compound.
Summary for isradipine
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 5 |
| NDAs: | 5 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 89 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,657 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends 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 |
| The Parkinson Study Group | Phase 3 |
| Michael J. Fox Foundation for Parkinson's Research | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs Teva | ISRADIPINE | isradipine | CAPSULE;ORAL | 077317-001 | Jan 5, 2006 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| 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 | |||
| Smithkline Beecham | DYNACIRC | isradipine | CAPSULE;ORAL | 019546-002 | Dec 20, 1990 | DISCN | Yes | 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 |
Expired US Patents for isradipine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-002 | Jun 1, 1994 | Start Trial | Start Trial |
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-002 | Jun 1, 1994 | Start Trial | Start Trial |
| Smithkline Beecham | DYNACIRC | isradipine | CAPSULE;ORAL | 019546-001 | Dec 20, 1990 | Start Trial | Start Trial |
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-001 | Jun 1, 1994 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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