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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
QuintilesIMS
UBS
Harvard Business School
Healthtrust
McKesson
Fish and Richardson
Johnson and Johnson
Teva

Generated: October 20, 2018

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CLEVIPREX Drug Profile

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When do Cleviprex patents expire, and when can generic versions of Cleviprex launch?

Cleviprex is a drug marketed by Chiesi Usa Inc and is included in one NDA. There are three patents protecting this drug.

The generic ingredient in CLEVIPREX is clevidipine. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the clevidipine profile page.

Drug patent expirations by year for CLEVIPREX
Generic Entry Opportunity Date for CLEVIPREX
Generic Entry Date for CLEVIPREX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
EMULSION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for CLEVIPREX
Synonyms for CLEVIPREX
(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
AK163183
AKOS015896325
AMX10159
AN-16754
AS-19935
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
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 (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
HE317022
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
OR074104
rac-Clevidipine
RL02144
s2080
SCHEMBL115522
SR-01000945183
SR-01000945183-1
SR-01000945183-2
Tox21_113923
W-5232
Z1691545244
Z1845

US Patents and Regulatory Information for CLEVIPREX

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Chiesi Usa Inc CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Chiesi Usa Inc CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ 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 CLEVIPREX

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

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Supplementary Protection Certificates for CLEVIPREX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00520 Netherlands ➤ Try a Free Trial PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: RVG 104771 20111129; FIRST REGISTRATION: PL 16881/0003 20111123
C0053 France ➤ Try a Free Trial PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: GB - PL 16881/0003 20111123
209 Luxembourg ➤ Try a Free Trial PRODUCT NAME: CLEVIDIPINE SOUS TOUTES LES FORMES PROCURANT UNE PROTECTION A PARTIR DU BREVET DE BASE
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
QuintilesIMS
UBS
Harvard Business School
Healthtrust
McKesson
Fish and Richardson
Johnson and Johnson
Teva

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.