You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 18, 2024

Nicardipine hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
Changjiang Shipping General HospitalPhase 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
Glenmark Pharms Ltd NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 216357-002 Dec 16, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma Intl Pharms NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE nicardipine hydrochloride INJECTABLE;INTRAVENOUS 022276-002 Apr 7, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chiesi CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074670-002 Oct 28, 1996 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chiesi CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-004 Nov 7, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 217555-002 May 3, 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 nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 ⤷  Try a Trial ⤷  Try a Trial
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-001 Feb 21, 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 SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-003 Feb 21, 1992 ⤷  Try a Trial ⤷  Try a Trial
Chiesi CARDENE nicardipine hydrochloride CAPSULE;ORAL 019488-001 Dec 21, 1988 ⤷  Try a Trial ⤷  Try a Trial
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-002 Feb 21, 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
South Korea 20090040258 PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2007121483 ⤷  Try a Trial
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) ⤷  Try a Trial
European Patent Office 2018152 COMPOSITIONS PHARMACEUTIQUES PRÉMÉLANGÉES PRÊTES À L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
Brazil PI0710287 composição farmacêutica, método para tratar um indivìduo quanto à pressão sangüìnea elevada, complexo de inclusão, e, métodos para tratar e evitar elevações agudas da pressão sangüinea em um indivìduo humano e para induzir a hipotensão em um indivìduo humano. ⤷  Try a Trial
Japan 2009534409 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.