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Generated: December 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022156

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NDA 022156 describes CLEVIPREX, which is a drug marketed by Chiesi Usa Inc and is included in one NDA. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the clevidipine profile page.
Summary for 022156
Tradename:CLEVIPREX
Applicant:Chiesi Usa Inc
Ingredient:clevidipine
Patents:3
Generic Entry Opportunity Date for 022156
Generic Entry Date for 022156*:
Constraining patent/regulatory exclusivity:
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 ActionCalcium 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:RXDosage:EMULSION;INTRAVENOUSStrength25MG/50ML (0.5MG/ML)
Approval Date:Aug 1, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 10, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 5, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:CLEVIPREX IS A DIHYDROPYRIDINE CALCIUM CHANNEL BLOCKER INDICATED FOR THE REDUCTION OF BLOOD PRESSURE WHEN ORAL THERAPY IS NOT FEASIBLE OR NOT DESIRABLE
Patent:➤ Sign UpPatent Expiration:Oct 10, 2031Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022156

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

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