NICARDIPINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Nicardipine Hydrochloride, and when can generic versions of Nicardipine Hydrochloride launch?

Nicardipine Hydrochloride is a drug marketed by 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-six NDAs.

The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nicardipine Hydrochloride

A generic version of NICARDIPINE HYDROCHLORIDE was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for NICARDIPINE HYDROCHLORIDE

US Patents:	0
Applicants:	22
NDAs:	26
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
Hikma Intl Pharms	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	022276-003	Apr 7, 2016	AP	RX	Yes	Yes
Somerset Theraps Llc	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	INJECTABLE;INJECTION	090664-001	Nov 17, 2009	AP	RX	No	No
Micro Labs	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	INJECTABLE;INJECTION	216420-001	Jul 7, 2023	AP	RX	No	No
Sun Pharm	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	INJECTABLE;INJECTION	078405-001	Nov 17, 2009		DISCN	No	No
Nanjing King Friend	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	INJECTABLE;INJECTION	216819-001	Aug 20, 2025	AP	RX	No	No
Amneal	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	218202-001	Apr 10, 2024	AB	RX	No	No
Pharmobedient	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	074642-002	Jul 18, 1996		DISCN	No	No