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Last Updated: February 28, 2021

DrugPatentWatch Database Preview

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

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Drug patent expirations by year for CLEVIPREX
Drug Prices for CLEVIPREX

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Generic Entry Opportunity Date for CLEVIPREX
Generic Entry Date for CLEVIPREX*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University of California, San FranciscoEarly Phase 1
University of ZurichPhase 4
The Medicines CompanyN/A

See all CLEVIPREX clinical trials

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

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

Supplementary Protection Certificates for CLEVIPREX

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

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Serving leading biopharmaceutical companies globally:

Medtronic
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Harvard Business School
Johnson and Johnson
McKesson
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.