Details for New Drug Application (NDA): 022156

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NDA 022156 describes CLEVIPREX, which is a drug marketed by Chiesi and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the CLEVIPREX profile page.

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

Summary for 022156

Tradename:	CLEVIPREX
Applicant:	Chiesi
Ingredient:	clevidipine
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022156

Generic Entry Date for 022156^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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 NDA: 022156

Mechanism of Action	Calcium Channel Antagonists

Suppliers and Packaging for NDA: 022156

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156	NDA	Chiesi USA, Inc.	10122-610	10122-610-10	10 CARTON in 1 CARTON (10122-610-10) / 1 VIAL, SINGLE-USE in 1 CARTON (10122-610-01) / 50 mL in 1 VIAL, SINGLE-USE
CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156	NDA	Chiesi USA, Inc.	10122-611	10122-611-10	10 CARTON in 1 CARTON (10122-611-10) / 1 VIAL, SINGLE-USE in 1 CARTON (10122-611-01) / 100 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;INTRAVENOUS			Strength	25MG/50ML (0.5MG/ML)
Approval Date:	Aug 1, 2008	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Oct 10, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Oct 10, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Oct 10, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022156

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

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