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Last Updated: February 28, 2021

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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, Navinta Llc, Rk Pharma, Sun Pharma Global, West-ward Pharms Int, and Wockhardt, and is included in fifteen NDAs. There are five 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. Ten suppliers are listed for this compound.

Recent Clinical Trials for nicardipine hydrochloride

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

SponsorPhase
Tianjin Nankai HospitalN/A
Pr. Semir NouiraPhase 3
Damietta UniversityPhase 2

See all nicardipine hydrochloride clinical trials

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 074928-002 Mar 19, 1998 RX No Yes   Start Trial   Start Trial   Start Trial
Ani Pharms Inc NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074439-001 Dec 10, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Chiesi CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 DISCN Yes No   Start Trial   Start Trial   Start Trial
Chiesi CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-004 Nov 7, 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 Y   Start Trial
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-002 Feb 21, 1992 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 nicardipine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992   Start Trial   Start Trial
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-003 Feb 21, 1992   Start Trial   Start Trial
Chiesi CARDENE nicardipine hydrochloride CAPSULE;ORAL 019488-001 Dec 21, 1988   Start Trial   Start Trial
Chiesi CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 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:

Moodys
Express Scripts
Boehringer Ingelheim
Mallinckrodt
Colorcon
McKesson

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