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Last Updated: November 2, 2024

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 ten branded drugs marketed by Chiesi, Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Norvium Bioscience, Senores Pharms, Skg Pharma, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma Intl Pharms, Micro Labs, Navinta Llc, Rk Pharma, Sun Pharm, West-ward Pharms Int, Wockhardt, and Inforlife, and is included in twenty-three NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nicardipine hydrochloride has twenty-one patent family members in ten countries.

There are eleven drug master file entries for nicardipine hydrochloride. Twenty-two suppliers are listed for this compound.

Summary for NICARDIPINE HYDROCHLORIDE
Recent Clinical Trials for NICARDIPINE HYDROCHLORIDE

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

SponsorPhase
Boston Medical CenterPhase 4
University of Illinois at ChicagoEarly Phase 1
Nanjing First Hospital, Nanjing Medical UniversityN/A

See all NICARDIPINE HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for NICARDIPINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for NICARDIPINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER Injection nicardipine hydrochloride 2.5 mg/mL, 10 mL Ampoules 019734 1 2006-12-27

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 Llc NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074928-001 Mar 19, 1998 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 216357-001 Dec 16, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
West-ward Pharms Int NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 078714-001 Dec 28, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chiesi CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-004 Nov 7, 2008 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Skg Pharma NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 218202-002 Apr 10, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chiesi CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-004 Nov 7, 2008 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Chiesi CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-002 Jul 31, 2008 RX Yes Yes ⤷  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 NICARDIPINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-002 Feb 21, 1992 ⤷  Sign Up ⤷  Sign Up
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-001 Feb 21, 1992 ⤷  Sign Up ⤷  Sign Up
Chiesi CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 ⤷  Sign Up ⤷  Sign Up
Chiesi CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 ⤷  Sign Up ⤷  Sign Up
Chiesi CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 ⤷  Sign Up ⤷  Sign Up
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-002 Feb 21, 1992 ⤷  Sign Up ⤷  Sign Up
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-003 Feb 21, 1992 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NICARDIPINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Japan 2009534388 ⤷  Sign Up
South Korea 20090037388 PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OF USE ⤷  Sign Up
China 101484006 Pre-mixed, ready-to-use iv bolus compositions and methods of use ⤷  Sign Up
European Patent Office 2012788 COMPOSITIONS EN BOLUS IV PRE-MELANGEES PRETES A L'EMPLOI ET PROCEDES D'UTILISATION (PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OF USE) ⤷  Sign Up
European Patent Office 2018152 COMPOSITIONS PHARMACEUTIQUES PRÉMÉLANGÉES PRÊTES À L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS) ⤷  Sign Up
Canada 2895102 COMPOSITIONS PHARMACEUTIQUES PREMELANGEES PRETES A L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS) ⤷  Sign Up
Australia 2007240820 Pre-mixed, ready-to-use pharmaceutical compositions ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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