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Last Updated: March 28, 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 eight branded drugs marketed by Chiesi, Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan, Senores Pharms, Am Regent, Eugia Pharma, Hikma Intl Pharms, Micro Labs, Navinta Llc, Rk Pharma, Sun Pharm, West-ward Pharms Int, and Wockhardt, and is included in twenty 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. Fifteen suppliers are listed for this compound.

Recent Clinical Trials for nicardipine hydrochloride

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

SponsorPhase
University of Illinois at ChicagoEarly Phase 1
Nanjing First Hospital, Nanjing Medical UniversityN/A
Zhongshan Hospital Xiamen UniversityPhase 3

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
West-ward Pharms Int NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 078714-001 Dec 28, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Micro Labs NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 216420-001 Jul 7, 2023 AP RX No No ⤷  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
Rk Pharma NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 090664-001 Nov 17, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Senores Pharms NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 215377-001 Jul 17, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 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 ⤷  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 SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-003 Feb 21, 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 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 nicardipine hydrochloride

Country Patent Number Title Estimated Expiration
New Zealand 572225 Pre-mixed pharmaceutical compositions comprising nicardipine, a tonicity agent, and a buffer ⤷  Try a Trial
Canada 2650922 COMPOSITIONS PHARMACEUTIQUES PREMELANGEES PRETES A L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
New Zealand 572226 Pre-mixed, ready-to-use IV bolus compositions comprising nicardipine and methods of use ⤷  Try a Trial
Brazil PI0709617 composição farmacêutica, e, métodos para tratar elevações agudas de pressão sangüìnea em um indivìduo humano, para induzir a hipotensão em um indivìduo humano, e para produzir uma composição farmacêutica para administração intravenosa ⤷  Try a Trial
Australia 2007240820 Pre-mixed, ready-to-use pharmaceutical compositions ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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