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Last Updated: July 19, 2024

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CLEVIPREX Drug Patent 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 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

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Drug patent expirations by year for CLEVIPREX
Drug Prices for CLEVIPREX

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 DiegoPhase 4
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Phase 3
University of California, San FranciscoEarly Phase 1

See all CLEVIPREX clinical trials

Pharmacology for CLEVIPREX
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CLEVIPREX is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

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

Patent: 11313852
Patent: Clevidipine emulsion formulations containing antimicrobial agents
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2013008601
Patent: formulações de emulsão de clevidipina contendo agentes antimicrobianos
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 14495
Patent: PREPARATIONS DE CLEVIDIPINE EN EMULSION CONTENANT DES AGENTS ANTIMICROBIENS (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 3237446
Patent: Clevidipine emulsion formulations containing antimicrobial agents
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 27173
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 2849
Patent: ЭМУЛЬСИОННЫЕ КОМПОЗИЦИИ КЛЕВИДИПИНА, СОДЕРЖАЩИЕ ПРОТИВОМИКРОБНЫЕ АГЕНТЫ (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Sign Up

Patent: 1390541
Patent: ЭМУЛЬСИОННЫЕ КОМПОЗИЦИИ КЛЕВИДИПИНА, СОДЕРЖАЩИЕ ПРОТИВОМИКРОБНЫЕ АГЕНТЫ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 27173
Patent: PRÉPARATIONS DE CLÉVIDIPINE EN ÉMULSION CONTENANT DES AGENTS ANTIMICROBIENS (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 87495
Patent: 含有抗微生物劑的氯維地平乳劑製劑 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 26295
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 40437
Estimated Expiration: ⤷  Sign Up

Patent: 26094
Estimated Expiration: ⤷  Sign Up

Patent: 37743
Estimated Expiration: ⤷  Sign Up

Patent: 14196322
Patent: 抗菌剤を含むクレビジピン乳化製剤 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Sign Up

Patent: 14504259
Estimated Expiration: ⤷  Sign Up

Patent: 16183183
Patent: 抗菌剤を含むクレビジピン乳化製剤 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 6537
Patent: FORMULACIONES DE EMULSION DE CLEVIDIPINA QUE CONTIENEN AGENTES ANTIMICROBIANOS. (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS.)
Estimated Expiration: ⤷  Sign Up

Patent: 13004151
Patent: FORMULACIONES DE EMULSION DE CLEVIDIPINA QUE CONTIENEN AGENTES ANTIMICROBIANOS. (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0465
Patent: Clevidipine emulsion formulations containing antimicrobial agents
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 27173
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 27173
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1786857
Estimated Expiration: ⤷  Sign Up

Patent: 130101080
Patent: CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS
Estimated Expiration: ⤷  Sign Up

Patent: 160032266
Patent: 항미생물제를 함유하는 클레비디핀 에멀젼 제제 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 39861
Estimated Expiration: ⤷  Sign Up

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
Taiwan 279859 ⤷  Sign Up
Brazil 112013008601 formulações de emulsão de clevidipina contendo agentes antimicrobianos ⤷  Sign Up
Poland 314263 ⤷  Sign Up
Australia 8119694 ⤷  Sign Up
New Zealand 275915 4-PHENYL SUBSTITUTED DIHYDROPYRIDINE 3,5-DICARBOXYLIC ACID ESTER DERIVATIVES AND MEDICAMENTS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CLEVIPREX

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

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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.