CLEVIPREX Drug Patent Profile

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

Cleviprex is a drug marketed by Chiesi and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in seventeen countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Cleviprex

Cleviprex was eligible for patent challenges on August 1, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 10, 2031. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CLEVIPREX

International Patents:	26
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	14
Patent Applications:	799
Drug Prices:	Drug price information for CLEVIPREX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLEVIPREX
What excipients (inactive ingredients) are in CLEVIPREX?	CLEVIPREX excipients list
DailyMed Link:	CLEVIPREX at DailyMed

See drug prices for CLEVIPREX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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.

Recent Clinical Trials for CLEVIPREX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Phase 3
University of California, San Francisco	Early Phase 1
University of Zurich	Phase 4

See all CLEVIPREX clinical trials

Pharmacology for CLEVIPREX

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CLEVIPREX

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for CLEVIPREX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLEVIPREX	Injectable Emulsion	clevidipine	25 mg/50 mL and 50 mg/100 mL	022156	1	2019-07-02

US Patents and Regulatory Information for CLEVIPREX

CLEVIPREX is protected by three US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CLEVIPREX

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

Expired US Patents for CLEVIPREX

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

International Patents for CLEVIPREX

When does loss-of-exclusivity occur for CLEVIPREX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Japan

Mexico

New Zealand

Poland

Portugal

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CLEVIPREX around the world.

Country	Patent Number	Title	Estimated Expiration
Egypt	20539	Process for preparing of dihydraphyridines and their use as pharmaceutical compositions in lowering blood pressure
Hungary	T74474
Japan	H09504542
New Zealand	276197	PHARMACEUTICAL EMULSION OF A 4-PHENYL SUBSTITUTED DIHYDROPYRIDINE 3,5-DICARBOXYLIC ACID ESTER DERIVATIVE
Japan	2014196322	抗菌剤を含むクレビジピン乳化製剤 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
South Korea	101786857
New Zealand	275915	4-PHENYL SUBSTITUTED DIHYDROPYRIDINE 3,5-DICARBOXYLIC ACID ESTER DERIVATIVES AND MEDICAMENTS

Supplementary Protection Certificates for CLEVIPREX

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