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 Norvium Bioscience, 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. Four suppliers are listed for this compound.
Summary for isradipine
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 119 |
Clinical Trials: | 12 |
Patent Applications: | 7,385 |
Drug Prices: | Drug price trends for isradipine |
What excipients (inactive ingredients) are in isradipine? | isradipine excipients list |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Norvium Bioscience | ISRADIPINE | isradipine | TABLET, EXTENDED RELEASE;ORAL | 201067-002 | Nov 27, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Norvium Bioscience | ISRADIPINE | isradipine | TABLET, EXTENDED RELEASE;ORAL | 201067-001 | Nov 27, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Watson Labs Teva | ISRADIPINE | isradipine | CAPSULE;ORAL | 077317-002 | Jan 5, 2006 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-002 | Jun 1, 1994 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-002 | Jun 1, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Smithkline Beecham | DYNACIRC | isradipine | CAPSULE;ORAL | 019546-001 | Dec 20, 1990 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-001 | Jun 1, 1994 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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