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Last Updated: November 30, 2022

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, Epic Pharma, Mylan, Am Regent, Eugia Pharma, Hikma Intl Pharms, Navinta Llc, Rk Pharma, Sun Pharm, West-ward Pharms Int, and Wockhardt, and is included in sixteen 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. Eleven suppliers are listed for this compound.

Recent Clinical Trials for nicardipine hydrochloride

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

SponsorPhase
Nanjing First Hospital, Nanjing Medical UniversityN/A
Qujing first people's HospitalPhase 3
The Affiliated Hospital of Xuzhou Medical 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
Mylan NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074642-001 Jul 18, 1996 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chiesi CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-004 Nov 7, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chiesi CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ani Pharms NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074439-001 Dec 10, 1996 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chiesi CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-005 Nov 7, 2008 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Chiesi CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-004 Nov 7, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Chiesi CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-002 Jul 31, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Chiesi CARDENE nicardipine hydrochloride CAPSULE;ORAL 019488-001 Dec 21, 1988 See Plans and Pricing See Plans and Pricing
Chiesi CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 See Plans and Pricing See Plans and Pricing
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-001 Feb 21, 1992 See Plans and Pricing See Plans and Pricing
Chiesi CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 See Plans and Pricing See Plans and Pricing
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-002 Feb 21, 1992 See Plans and Pricing See Plans and Pricing
Chiesi CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-003 Feb 21, 1992 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for nicardipine hydrochloride

Country Patent Number Title Estimated Expiration
Israel 194799 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2007123984 See Plans and Pricing
Japan 2009534388 See Plans and Pricing
Canada 2650922 COMPOSITIONS PHARMACEUTIQUES PREMELANGEES PRETES A L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS) See Plans and Pricing
Australia 2007240820 Pre-mixed, ready-to-use pharmaceutical compositions See Plans and Pricing
Canada 2649779 COMPOSITIONS EN BOLUS IV PRE-MELANGEES PRETES A L'EMPLOI ET PROCEDES D'UTILISATION (PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OFUSE) See Plans and Pricing
Mexico 2008013407 COMPOSICIONES DE BOLO IV PREMEZCLADAS, LISTAS PARA USO Y METODOS DE USO. (PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OF USE.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Boehringer Ingelheim
Mallinckrodt
Colorcon
McKesson

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