Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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AstraZeneca
Merck
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Last Updated: December 14, 2019

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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 freedom to operate?

Nicardipine hydrochloride is the generic ingredient in eight branded drugs marketed by Chiesi Usa Inc, Ani Pharms Inc, Epic Pharma, Mylan, Exela Pharma Science, Luitpold, 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. Seven suppliers are listed for this compound.

Recent Clinical Trials for nicardipine hydrochloride

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

SponsorPhase
National Institute of Neurological Disorders and Stroke (NINDS)Phase 2
Vanderbilt University Medical CenterPhase 2
Assiut UniversityEarly Phase 1

See all nicardipine hydrochloride clinical trials

Recent Litigation for nicardipine hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Cornerstone Biopharma Inc. v. Exela Pharma Sciences LLC2013-07-24
Endo Pharmaceuticals Inc., and Grunenthal GbmH v. Teva Pharmaceuticals USA, Inc., and Barr Laboratories, Inc.2012-11-05
Purdue Pharma LP v. Sandoz Inc.2012-10-10

See all nicardipine hydrochloride litigation

PTAB Litigation
PetitionerDate
Sandoz Inc.2014-10-01

See all nicardipine hydrochloride litigation

Medical Subject Heading (MeSH) Categories for nicardipine hydrochloride
Synonyms for nicardipine 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
BCP05610
BCP9000988
Bionicard
C25H27N3O6.HCl
Cardene
Cardene (TN)
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 hydrochloride,(S)
nicardipine;
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
SR-01000075333-5
SW196762-3
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
Epic Pharma NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074928-001 Mar 19, 1998 AB RX No No   Start Trial   Start Trial   Start Trial
Exela Pharma Science NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 022276-001 Jul 24, 2008 RX No No   Start Trial   Start Trial   Start Trial
Luitpold NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 090534-001 Nov 17, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Chiesi Usa Inc CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-002 Jul 31, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Epic Pharma NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074928-002 Mar 19, 1998 AB RX No No   Start Trial   Start Trial   Start 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

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

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Express Scripts
Merck
Dow
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