CARDENE Drug Patent Profile
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When do Cardene patents expire, and when can generic versions of Cardene launch?
Cardene is a drug marketed by Chiesi and is included in three NDAs. There are six patents protecting this drug.
The generic ingredient in CARDENE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cardene
A generic version of CARDENE was approved as nicardipine hydrochloride by ANI PHARMS on October 28th, 1996.
Summary for CARDENE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 173 |
| Clinical Trials: | 8 |
| Patent Applications: | 3,751 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CARDENE |
| What excipients (inactive ingredients) are in CARDENE? | CARDENE excipients list |
| DailyMed Link: | CARDENE at DailyMed |
Recent Clinical Trials for CARDENE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Cincinnati | Phase 2 |
| Vanderbilt University Medical Center | Phase 2 |
| National Institute of Neurological Disorders and Stroke (NINDS) | Phase 2 |
Pharmacology for CARDENE
Anatomical Therapeutic Chemical (ATC) Classes for CARDENE
US Patents and Regulatory Information for CARDENE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chiesi | CARDENE SR | nicardipine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020005-003 | Feb 21, 1992 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chiesi | CARDENE | nicardipine hydrochloride | CAPSULE;ORAL | 019488-001 | Dec 21, 1988 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chiesi | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 019734-002 | Jul 31, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chiesi | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 019734-005 | Nov 7, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
Expired US Patents for CARDENE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chiesi | CARDENE | nicardipine hydrochloride | CAPSULE;ORAL | 019488-001 | Dec 21, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CARDENE
See the table below for patents covering CARDENE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 63810 | ⤷ Try a Trial | |
| France | 2218107 | ⤷ Try a Trial | |
| Spain | 446105 | ⤷ Try a Trial | |
| Japan | S60246313 | INJECTION OF NICARDIPINE HYDROCHLORIDE AND ITS PREPARATION | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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