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Last Updated: October 19, 2019

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Nisoldipine - Generic Drug Details

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What are the generic sources for nisoldipine and what is the scope of freedom to operate?

Nisoldipine is the generic ingredient in two branded drugs marketed by Mylan and Covis Pharma Bv, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for nisoldipine. Three suppliers are listed for this compound.

Drug Prices for nisoldipine

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Recent Clinical Trials for nisoldipine

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

SponsorPhase
Mylan PharmaceuticalsPhase 1
BayerPhase 4
Steno Diabetes CenterPhase 4

See all nisoldipine clinical trials

Recent Litigation for nisoldipine

Identify potential future generic entrants

District Court Litigation
Case NameDate
Endo Pharmaceuticals Inc. v. Sandoz Inc.2008-08-22
UCB Inc. v. KV Pharmaceutical Company2008-04-18
Sanofi-Aventis v. Wockhardt Limited2008-03-14

See all nisoldipine litigation

Pharmacology for nisoldipine
Medical Subject Heading (MeSH) Categories for nisoldipine
Synonyms for nisoldipine
(.+/-.)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate
(.+/-.)-Nisoldipine
(+-)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate
(+/-)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate
1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic Acid Isobutyl Methyl Ester
1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid methyl 2-methylpropyl ester
2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic acid O3-methyl ester O5-(2-methylpropyl) ester
3-Isobutyl 5-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylate #
3-Isobutyl 5-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
3-methyl 5-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
3-O-methyl 5-O-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester
3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester, (.+/-.)-
3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester, (+-)-
63675-72-9
675N729
A834466
AB0106136
AB01275444_02
AB01275444-01
AB2000270
AC-987
AC1L1IAY
AKOS005563632
AN-6975
Bay k 5552
BAY-k 5552
Bay-k-5552
Baymycard
BBL028683
BC204167
BCP22696
BDBM50101963
BDBM50227259
BIDD:GT0684
BRD-A84465106-001-01-2
BRN 0454188
C07699
C20H24N2O6
CAS-63675-72-9
CCG-100894
CCG-213412
CHEBI:76917
CHEMBL1726
CHEMBL3192341
CHEMBL441428
CPD004727075
CS-1131
CTK8G1888
D00618
DB00401
DL-255
DSSTox_CID_3371
DSSTox_GSID_23371
DSSTox_RID_76999
DTXSID0023371
EINECS 264-407-7
FT-0082489
FT-0601599
GTPL2524
HMS2051O18
HMS2089K20
HMS2093F15
HMS2097E13
HMS2231L20
HMS3393O18
HMS3651K17
HMS3714E13
HY-17402
Isobutyl 1,4-dihydro-5-methoxycarbonyl-2,6-dimethyl-4-(2-nitrophenyl)-3-pyridincarboxylat
Isobutyl Methyl 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate
isobutyl methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
J10291
KM0774
KS-000001QK
KS-5188
LS-131295
MCULE-5009799152
methyl 2-methylpropyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
MFCD00478055
MLS000759498
MLS001424102
MLS002153943
MolPort-003-666-664
N0900
NC00144
NCGC00164633-01
NCGC00164633-02
NCGC00164633-03
NCGC00255136-01
Nisocor
Nisoldipin
Nisoldipina
Nisoldipine (JAN/USAN/INN)
nisoldipine (product)
Nisoldipine [USAN:BAN:INN:JAN]
Nisoldipine [USAN:INN:BAN:JAN]
Nisoldipine, >=98% (HPLC)
Nisoldipine, ~97%
Nisoldipine,(S)
Nisoldipine;
Nisoldipino
Nisoldipino [INN-Spanish]
Nisoldipinum
Nisoldipinum [INN-Latin]
NSC-759106
NSC759106
O3-methyl O5-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
O5-isobutyl O3-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
O5-methyl O3-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
Pharmakon1600-01505390
s1748
SAM001246719
SBI-0206830.P001
SC-18015
SCHEMBL39779
SMR000466370
SR-05000002009
SR-05000002009-1
SR-05000002009-2
SR-05000002009-3
ST24042247
STK631543
Sular
Sular (TN)
SW219237-1
Syscor
Tox21_112251
Tox21_112251_1
Tox21_302365
VKQFCGNPDRICFG-UHFFFAOYSA-N
Z277942268
Zadipina
Zadipina;Bay k 5552;Baymycard;Sular

US Patents and Regulatory Information for nisoldipine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 079051-001 Jul 25, 2008 RX No No   Start Trial   Start Trial   Start Trial
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-001 Feb 2, 1995 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 079051-002 Jul 25, 2008 RX No Yes   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 nisoldipine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-007 Jan 2, 2008   Start Trial   Start Trial
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-004 Feb 2, 1995   Start Trial   Start Trial
Covis Pharma Bv SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-005 Jan 2, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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