nicardipine hydrochloride - Profile

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, Amneal, Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Navinta Llc, Pharmobedient, Senores Pharms, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma, Hikma Intl Pharms, Mankind Pharma, Micro Labs, Nanjing King Friend, Qilu Pharm Hainan, Somerset Theraps Llc, Sun Pharm, Inforlife, Caplin, and Cipla, and is included in twenty-nine 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.

Summary for nicardipine hydrochloride

International Patents:	21
US Patents:	6
Tradenames:	10
Applicants:	23
NDAs:	29
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-001	Feb 21, 1992		DISCN	Yes	No
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992		DISCN	Yes	No
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992		DISCN	Yes	No
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988		DISCN	Yes	No
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-002	Dec 21, 1988		DISCN	Yes	No
Amneal	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	218202-001	Apr 10, 2024	AB	RX	No	No
Amneal	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	218202-002	Apr 10, 2024	AB	RX	No	No

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	020005-003	Feb 21, 1992	5,198,226
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	4,880,823
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	3,985,758
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-001	Feb 21, 1992	3,985,758
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	5,164,405
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988	3,985,758
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992	3,985,758

International Patents for nicardipine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2007237903
Australia	2007240820	Pre-mixed, ready-to-use pharmaceutical compositions
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
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.
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)
Canada	2650922	COMPOSITIONS PHARMACEUTIQUES PREMELANGEES PRETES A L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS)
Canada	2895102	COMPOSITIONS PHARMACEUTIQUES PREMELANGEES PRETES A L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS)