NICARDIPINE HYDROCHLORIDE Drug Patent Profile

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Nicardipine Hydrochloride is a drug marketed by Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan, Senores Pharms, Skg Pharma, Am Regent, Eugia Pharma, Hikma Intl Pharms, Micro Labs, Navinta Llc, Rk Pharma, Sun Pharm, West-ward Pharms Int, Wockhardt, and Inforlife. and is included in nineteen NDAs.

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

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

US Patents:	0
Applicants:	17
NDAs:	19
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	52
Patent Applications:	1,573
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NICARDIPINE HYDROCHLORIDE
What excipients (inactive ingredients) are in NICARDIPINE HYDROCHLORIDE?	NICARDIPINE HYDROCHLORIDE excipients list
DailyMed Link:	NICARDIPINE HYDROCHLORIDE at DailyMed

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

Sponsor	Phase
University of Illinois at Chicago	Early Phase 1
Nanjing First Hospital, Nanjing Medical University	N/A
Taian Central Hospital	Phase 3

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

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

NICARDIPINE HYDROCHLORIDE is protected by zero US patents and one FDA Regulatory Exclusivity.

COMPETITIVE GENERIC THERAPY
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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Inforlife	NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	203978-002	Apr 17, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Inforlife	NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	203978-001	Apr 17, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	074439-001	Dec 10, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Skg Pharma	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	218202-002	Apr 10, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rk Pharma	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	INJECTABLE;INJECTION	090664-001	Nov 17, 2009	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bionpharma	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	217555-001	May 3, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	074439-002	Dec 10, 1996		DISCN	No	No	⤷ 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