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

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Last Updated: October 19, 2019

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Clevidipine - Generic Drug Details

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What are the generic drug sources for clevidipine and what is the scope of patent protection?

Clevidipine is the generic ingredient in one branded drug marketed by Chiesi Usa Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Clevidipine has sixty-six patent family members in thirty-three countries.

There are three drug master file entries for clevidipine. Two suppliers are listed for this compound.

Recent Clinical Trials for clevidipine

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SponsorPhase
University of California, San FranciscoEarly Phase 1
University of ZurichPhase 4
Nationwide Children's HospitalPhase 2/Phase 3

See all clevidipine clinical trials

Recent Litigation for clevidipine

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District Court Litigation
Case NameDate
CHIESI USA, INC. v. AUROBINDO PHARMA USA, INC.2019-10-07

See all clevidipine litigation

Pharmacology for clevidipine
Synonyms for clevidipine
(Butanoyloxy)methyl methyl (4RS)-4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
166432-28-6
167221-71-8
221C718
3-((butyryloxy)methyl) 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarb
3-((butyryloxy)methyl) 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
3-[(Butyryloxy)methyl] 5-Methyl 4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
3,5-Pyridinedicarboxylic acid, 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-, methyl (1-oxobutoxy)methyl ester
4-(2,3-Dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic Acid 3-Methyl 5-[(1-Oxobutoxy)methyl] Ester
4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic Aicd 3-[(Butyryloxy)methyl] 5-Methyl Ester
5-O-(butanoyloxymethyl) 3-O-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
AB01566888_01
AB2000484
ABP001090
AC-24370
AC1L4BI0
AKOS015896325
AMX10159
AN-16754
AS-19935
BCP22687
BDBM50088387
Butyroxymethyl methyl 4-(2',3'-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylat
butyroxymethyl methyl 4-(2',3'-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
C21H23Cl2NO6
C3503
CAS-167221-71-8
CC0258
CHEBI:135738
CHEMBL1237132
Clevelox
Clevidipine (USAN/INN)
Clevidipine [USAN:INN]
Clevidipine butyrate
Clevidipine, Cleviprex
Clevidipine; Methyl (1-oxobutoxy)methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dime thyl-3,5-pyridinedicarboxylate
Cleviprex
Cleviprex (Clevidipine)
Cleviprex (TN)
CS-1427
CTK4D2578
D08892
DB04920
DSSTox_CID_31450
DSSTox_GSID_57661
DSSTox_RID_97336
DTXSID6057661
FT-0659562
FT-0688416
GTPL7468
H 324/38
H-324/38
H324/38
HMS3604H21
HMS3651G10
HY-17436
I06-2062
I14-17270
J-520103
KB-53558
KPBZROQVTHLCDU-UHFFFAOYSA-N
KS-00000XIM
MCULE-6863602192
Methyl (1-oxobutoxy)methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dime thyl-3,5-pyridinedicarboxylate
Methyl (1-oxobutoxy)methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate
METHYL 5-{[(BUTANOYLOXY)METHOXY]CARBONYL}-4-(2,3-DICHLOROPHENYL)-2,6-DIMETHYL-1,4-DIHYDROPYRIDINE-3-CARBOXYLATE
MolPort-020-006-047
NCGC00262928-01
O3-(butanoyloxymethyl) O5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
O5-(butanoyloxymethyl) O3-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
rac-Clevidipine
RL02144
s2080
SCHEMBL115522
SR-01000945183
SR-01000945183-1
SR-01000945183-2
SW220087-1
Tox21_113923
W-5232
Z1691545244
Z1845

US Patents and Regulatory Information for clevidipine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi Usa Inc CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-001 Aug 1, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Chiesi Usa Inc CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Chiesi Usa Inc CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Chiesi Usa Inc CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Chiesi Usa Inc CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-001 Aug 1, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Chiesi Usa Inc CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008 RX Yes Yes   Start Trial   Start Trial Y   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 clevidipine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi Usa Inc CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-001 Aug 1, 2008   Start Trial   Start Trial
Chiesi Usa Inc CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008   Start Trial   Start Trial
Chiesi Usa Inc CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for clevidipine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0726894 C00726894/01 Switzerland   Start Trial PRODUCT NAME: RACEMISCHES CLEVIDIPINBUTYRAT; REGISTRATION NO/DATE: SWISSMEDIC 60117 11.06.2010
0726894 92209 Luxembourg   Start Trial PRODUCT NAME: CLEVIDIPINE SOUS TOUTES LES FORMES PROCURANT UNE PROTECTION A PARTIR DU BREVET DE BASE
0726894 12C0053 France   Start Trial PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: GB - PL 16881/0003 20111123
0726894 1290008-0 Sweden   Start Trial PRODUCT NAME: CLEVIDIPINE; NAT. REG. NO/DATE: 42321 20120120; FIRST REG.: GB PL 16881/0003 20111123
0726894 SPC/GB12/011 United Kingdom   Start Trial PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123
0726894 C300520 Netherlands   Start Trial PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: RVG 104771 20111129; FIRST REGISTRATION: PL 16881/0003 20111123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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