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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.

Summary for CLEVIPREX

US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Bulk Api Vendors:	65
Clinical Trials:	11
Patent Applications:	496
Drug Prices:	Drug price information for CLEVIPREX
DailyMed Link:	CLEVIPREX at DailyMed

Generic Entry Opportunity Date for CLEVIPREX

NDA:

022156

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

Ingredient-type	Dihydropyridines
Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

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

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
Chiesi Usa Inc	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008
Chiesi Usa Inc	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-003	Nov 8, 2013

International Patents for CLEVIPREX

Country	Document Number	Estimated Expiration
Spain	2539861
Finland	961914
Czech Republic	9601273

Supplementary Protection Certificates for CLEVIPREX

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