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Last Updated: August 6, 2020

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CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER Drug Profile

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Which patents cover Cardene In 4.8% Dextrose In Plastic Container, and when can generic versions of Cardene In 4.8% Dextrose In Plastic Container launch?

Cardene In 4.8% Dextrose In Plastic Container is a drug marketed by Chiesi and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-three patent family members in eleven countries.

The generic ingredient in CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Cardene In 4.8% Dextrose In Plastic Container

A generic version of CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER was approved as nicardipine hydrochloride by MYLAN on July 18th, 1996.

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Summary for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Drug patent expirations by year for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Recent Clinical Trials for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Vanderbilt University Medical CenterPhase 2
National Institute of Neurological Disorders and Stroke (NINDS)Phase 2
University of ZurichPhase 4

See all CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER clinical trials

Paragraph IV (Patent) Challenges for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

US Patents and Regulatory Information for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-002 Jul 31, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Chiesi CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-002 Jul 31, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Chiesi CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-002 Jul 31, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Chiesi CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-002 Jul 31, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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