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Last Updated: May 9, 2024

Nicardipine hydrochloride - Generic Drug Details

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What are the generic drug 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, Skg Pharma, 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-one 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. Eighteen suppliers are listed for this compound.

Summary for nicardipine hydrochloride

International Patents:	21
US Patents:	6
Tradenames:	8
Applicants:	17
NDAs:	21
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	52
Patent Applications:	2,733
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

Recent Clinical Trials for nicardipine hydrochloride

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
Xuancheng people's hospital	Phase 3

See all nicardipine hydrochloride clinical trials

Pharmacology for nicardipine hydrochloride

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

Medical Subject Heading (MeSH) Categories for nicardipine hydrochloride

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for nicardipine hydrochloride

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

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

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Glossary

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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
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Bionpharma	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	217555-001	May 3, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Skg Pharma	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	218202-001	Apr 10, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Skg Pharma	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	218202-002	Apr 10, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Eugia Pharma	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	INJECTABLE;INJECTION	211121-001	Apr 8, 2021	AP	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-001	Feb 21, 1992	⤷ Try a Trial	⤷ Try a Trial
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	020005-003	Feb 21, 1992	⤷ Try a Trial	⤷ Try a Trial
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	020005-002	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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007121483		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007123984		⤷ Try a Trial
New Zealand	572225	Pre-mixed pharmaceutical compositions comprising nicardipine, a tonicity agent, and a buffer	⤷ Try a Trial
Japan	2009534409		⤷ Try a Trial
Mexico	2008013405	COMPOSICIONES FARMACEUTICAS PREMEZCLADAS LISTAS PARA USO. (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS.)	⤷ Try a Trial
South Korea	20090040258	PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS	⤷ Try a Trial
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)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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