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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 and is included in one NDA. There are three patents protecting this drug.

This drug has sixty-seven patent family members in thirty-three 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.

US ANDA Litigation and 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 has been one patent litigation case 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:	67
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	87
Clinical Trials:	13
Patent Applications:	638
Drug Prices:	Drug price information for CLEVIPREX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLEVIPREX
DailyMed Link:	CLEVIPREX at DailyMed

See drug prices for CLEVIPREX

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.

Recent Clinical Trials for CLEVIPREX

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

Sponsor	Phase
University of California, San Francisco	Early Phase 1
University of Zurich	Phase 4
The Medicines Company	N/A

See all CLEVIPREX clinical trials

Pharmacology for CLEVIPREX

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

Paragraph IV (Patent) Challenges for CLEVIPREX

Tradename	Dosage	Ingredient	NDA	Submissiondate
CLEVIPREX	EMULSION;INTRAVENOUS	clevidipine	022156	2019-07-02

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	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-001	Aug 1, 2008		RX	Yes	Yes			Y	Y
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-003	Nov 8, 2013		DISCN	Yes	No			Y	Y
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008		RX	Yes	Yes			Y	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

Expired US Patents for CLEVIPREX

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

International Patents for CLEVIPREX

Country	Patent Number	Estimated Expiration
Czech Republic	9601338
Eurasian Patent Organization	201390541
Hungary	9601187
Norway	961898
Norway	305656

Supplementary Protection Certificates for CLEVIPREX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0726894	SPC/GB12/011	United Kingdom		PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123
0726894	1290008-0	Sweden		PRODUCT NAME: CLEVIDIPINE; NAT. REG. NO/DATE: 42321 20120120; FIRST REG.: GB PL 16881/0003 20111123
0726894	92209	Luxembourg		PRODUCT NAME: CLEVIDIPINE SOUS TOUTES LES FORMES PROCURANT UNE PROTECTION A PARTIR DU BREVET DE BASE
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