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Last Updated: April 26, 2024

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, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan, Senores Pharms, 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 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. Sixteen suppliers are listed for this compound.

Summary for NICARDIPINE HYDROCHLORIDE

International Patents:	21
US Patents:	6
Tradenames:	8
Applicants:	16
NDAs:	20
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	16
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
Qingdao Central 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

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 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
Rk Pharma	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	INJECTABLE;INJECTION	090664-001	Nov 17, 2009	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	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	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	⤷ Try a Trial	⤷ Try a Trial
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
>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
Australia	2007237903	Pre-mixed, ready-to-use iv bolus compositions and methods of use	⤷ Try a Trial
New Zealand	572225	Pre-mixed pharmaceutical compositions comprising nicardipine, a tonicity agent, and a buffer	⤷ Try a Trial
Japan	2009534388		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.