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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Chinese Patent Office
Mallinckrodt
Harvard Business School
QuintilesIMS
Cantor Fitzgerald
Federal Trade Commission
Daiichi Sankyo
UBS

Generated: August 17, 2018

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Nicardipine hydrochloride - Generic Drug Details

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What are the generic drug sources for nicardipine hydrochloride and what is the scope of nicardipine hydrochloride freedom to operate?

Nicardipine hydrochloride is the generic ingredient in eight branded drugs marketed by Chiesi Usa Inc, Ani Pharms Inc, Epic Pharma, Mylan, Watson Labs, Exela Pharma Science, Luitpold Pharms Inc, Mylan Institutional, Navinta Llc, Sun Pharma Global, West-ward Pharms Int, and Wockhardt, and is included in fifteen NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nicardipine hydrochloride has twenty-three patent family members in eleven countries.

There are eleven drug master file entries for nicardipine hydrochloride. Twelve suppliers are listed for this compound.

Medical Subject Heading (MeSH) Categories for nicardipine hydrochloride
Synonyms for nicardipine hydrochloride
1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid methyl 2-[methyl(phenylmethyl)amino]ethyl ester hydrochloride
1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)methyl-2-[methyl(phenylmethyl)amino]-3,5-pyridinedicarboxylic acid ethyl ester hydrochloride
1,4-Dihydro-2,6-dimethyl-4-[3-nitrophenyl]methyl-2-[methyl- (phenyl-methl)amino]-3,5- pyridinedicarboxylic acid ethyl ester
1,4-Dihydro-2,6-dimethyl-4-[3-nitrophenyl]methyl-2-[methyl-(phenyl-methl)amino]-3,5-pyridinedicarboxylic acid ethyl ester
2-(benzyl-methyl-amino)ethyl methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate hydrochloride
2-(Benzyl(methyl)amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)pyridine-3,5-dicarboxylate hydrochloride
2-(benzylmethylamino)ethl methyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride
2-(Benzylmethylamino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylatemonohydrochloride
2-(Benzylmethylamino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride
2-(N-benzyl-N-methylamino)ethyl methyl 2,6-dimethyl-4-(m-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate hydrochloride
2-[benzyl(methyl)amino]ethyl-methyl-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridin-3,5-dicarboxylathydrochlorid
2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic acid O3-methyl ester O5-[2-[methyl-(phenylmethyl)amino]ethyl] ester hydrochloride
3-(2-(benzyl(methyl)amino)ethyl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate hydrochloride
3-{2-[benzyl(methyl)amino]ethyl} 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate hydrochloride
3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 3-methyl 5-[2-[methyl(phenylmethyl)amino]ethyl] ester, hydrochloride (1:1)
3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, methyl 2-(methyl(phenylmethyl)amino)ethyl ester, monohydrochloride
3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-, 2-(benzylmethylamino)ethyl methyl ester, monohydrochloride
4- ?CHLORO- DIFLUORO- METHOXY) ? PHENYLAMINE
5-O-[2-[benzyl(methyl)amino]ethyl] 3-O-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate hydrochloride
5-O-[2-[benzyl(methyl)amino]ethyl] 3-O-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate;hydrochloride
527N843
54527-84-3
69441-18-5
A830225
AC1L253M
AC1Q67X4
AIKVCUNQWYTVTO-UHFFFAOYSA-N
AKOS015994734
AN-40518
Angioglebil
ANW-42546
BC201356
BCP9000988
Bionicard
C25H27N3O6.HCl
Cardene
Cardene In 0.83% Sodium Chloride In Plastic Container
Cardene In 0.86% Sodium Chloride In Plastic Container
Cardene In 4.8% Dextrose In Plastic Container
Cardene In 5.0% Dextrose In Plastic Container
Cardene SR
CAS-54527-84-3
CCG-39033
CCRIS 8508
CHEBI:7551
CHEMBL1200326
CHEMBL3199626
CPD004727071
CS-3684
CTK2F3563
D00617
Dafil
Dagan
DSSTox_CID_26992
DSSTox_GSID_46992
DSSTox_RID_82040
DTXSID9046992
EBD48801
EINECS 259-198-4
EINECS 274-007-4
EU-0100809
FT-0082866
FT-0630671
HMS1569M07
HMS1921H21
HY-12515A
KS-1276
Lincil
Loxen
LP00809
LS-131264
MFCD00057327
MLS000069782
MLS001146898
MLS002153279
MLS002153794
MolPort-003-666-362
N 7510
N0635
NC00578
NCGC00094142-01
NCGC00094142-02
NCGC00094142-03
NCGC00094142-04
NCGC00094142-05
NCGC00256289-01
NCGC00261494-01
NE54503
Nerdipine
Nicardil
Nicardipine (Hydrochloride)
Nicardipine for system suitability, European Pharmacopoeia (EP) Reference Standard
Nicardipine HCl
Nicardipine hydrochloride (JP17/USAN)
Nicardipine hydrochloride [USAN:JAN]
Nicardipine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Nicardipine hydrochloride, powder, >=98%
Nicardipine hydrochloride, United States Pharmacopeia (USP) Reference Standard
nicardipine;
Nicardipinehydrochloride
Nicodel
NSC-757855
NSC757855
O3-methyl O5-[2-[methyl-(phenylmethyl)amino]ethyl] 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate hydrochloride
O5-[2-[benzyl(methyl)amino]ethyl] O3-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate hydrochloride
Opera_ID_357
Perdipina
Perdipine
Perpidine
Pharmakon1600-01501135
Prestwick_590
RS-69216
RS-69216-XX-07-0
RS-69216-XX-07-O
s4181
SAM002564254
SAM002643513
SCHEMBL41845
SMR000058487
SPECTRUM1501135
SR-01000075333
SR-01000075333-1
TN-901
Tox21_301832
Tox21_500809
TR-019279
W-105615
YC 93
YC-93
YC-93 hydrochloride

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
Ani Pharms Inc NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074540-002 Oct 28, 1996 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Institutional NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 090664-001 Nov 17, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Ani Pharms Inc NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074439-001 Dec 10, 1996 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
West-ward Pharms Int NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 078714-001 Dec 28, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-003 Jul 31, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Navinta Llc NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 090125-001 Nov 17, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-001 Feb 21, 1992 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for nicardipine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-003 Feb 21, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-001 Feb 21, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE nicardipine hydrochloride CAPSULE;ORAL 019488-001 Dec 21, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-002 Feb 21, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-001 Feb 21, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for nicardipine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,659,290 Methods of preparing pre-mixed, ready-to-use pharmaceutical compositions ➤ Try a Free Trial
9,370,586 Methods of preparing pre-mixed, ready-to-use pharmaceutical compositions ➤ Try a Free Trial
9,549,994 Compositions of nicardipine and sulfoalkylated .beta.-cyclodextrin ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for nicardipine hydrochloride

Country Document Number Estimated Expiration
China 101484006 ➤ Try a Free Trial
South Korea 20090040258 ➤ Try a Free Trial
Canada 2650922 ➤ Try a Free Trial
New Zealand 572225 ➤ Try a Free Trial
Mexico 2008013405 ➤ Try a Free Trial
Australia 2007237903 ➤ Try a Free Trial
Brazil PI0709617 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Express Scripts
Johnson and Johnson
Cantor Fitzgerald
Harvard Business School
Colorcon
Medtronic
US Department of Justice
US Army

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 verifification 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.