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Last Updated: November 21, 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, Inforlife, and Cipla, and is included in twenty-four 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-four 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
Ani Pharms NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074540-002 Oct 28, 1996 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chiesi CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-003 Jul 31, 2008 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chiesi CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-003 Jul 31, 2008 AP 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 020005-001 Feb 21, 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
China 101484136 Pre-mixed, ready-to-use pharmaceutical compositions ⤷  Sign Up
China 101484006 Pre-mixed, ready-to-use iv bolus compositions and methods of use ⤷  Sign Up
Canada 2650922 COMPOSITIONS PHARMACEUTIQUES PREMELANGEES PRETES A L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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