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Last Updated: August 8, 2020

DrugPatentWatch Database Preview

NICARDIPINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for nicardipine hydrochloride and what is the scope of patent protection?

Nicardipine hydrochloride is the generic ingredient in eight branded drugs marketed by Chiesi, Ani Pharms Inc, Epic Pharma, Mylan, Am Regent, Exela Pharma Science, Mylan Institutional, Navinta Llc, Sun Pharma Global, West-ward Pharms Int, and Wockhardt, and is included in fifteen NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nicardipine hydrochloride has twenty-three patent family members in eleven countries.

There are eleven drug master file entries for nicardipine hydrochloride. Nine suppliers are listed for this compound.

Recent Clinical Trials for NICARDIPINE HYDROCHLORIDE

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SponsorPhase
Damietta UniversityPhase 2
Kafrelsheikh UniversityPhase 2
Kafrelsheikh UniversityPhase 3

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Medical Subject Heading (MeSH) Categories for NICARDIPINE HYDROCHLORIDE

US Patents and Regulatory Information for NICARDIPINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epic Pharma NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074928-001 Mar 19, 1998 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074642-002 Jul 18, 1996 AB RX No Yes   Start Trial   Start Trial   Start Trial
Chiesi CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-005 Nov 7, 2008 DISCN Yes No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074540-002 Oct 28, 1996 DISCN No 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 NICARDIPINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-003 Feb 21, 1992   Start Trial   Start Trial
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-001 Feb 21, 1992   Start Trial   Start Trial
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-002 Feb 21, 1992   Start Trial   Start Trial
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-003 Feb 21, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Medtronic
Merck
Boehringer Ingelheim
McKesson

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