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Last Updated: May 28, 2022

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

See drug prices for CLEVIPREX

DrugPatentWatch® Estimated 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
Chiesi Farmaceutici S.p.A.Phase 4

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-001 Aug 1, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-001 Aug 1, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 022156-002 Aug 1, 2008 See Plans and Pricing See Plans and Pricing
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-001 Aug 1, 2008 See Plans and Pricing See Plans and Pricing
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013 See Plans and Pricing See Plans and Pricing
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013 See Plans and Pricing See Plans and Pricing
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-001 Aug 1, 2008 See Plans and Pricing See Plans and Pricing
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008 See Plans and Pricing See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013008601
Estimated Expiration: See Plans and Pricing

Canada

Patent: 14495
Estimated Expiration: See Plans and Pricing

China

Patent: 3237446
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 27173
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2849
Estimated Expiration: See Plans and Pricing

Patent: 1390541
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 27173
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 87495
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 26295
Estimated Expiration: See Plans and Pricing

Japan

Patent: 40437
Estimated Expiration: See Plans and Pricing

Patent: 26094
Estimated Expiration: See Plans and Pricing

Patent: 37743
Estimated Expiration: See Plans and Pricing

Patent: 14196322
Estimated Expiration: See Plans and Pricing

Patent: 14504259
Estimated Expiration: See Plans and Pricing

Patent: 16183183
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6537
Estimated Expiration: See Plans and Pricing

Patent: 13004151
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0465
Estimated Expiration: See Plans and Pricing

Poland

Patent: 27173
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 27173
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1786857
Estimated Expiration: See Plans and Pricing

Patent: 130101080
Estimated Expiration: See Plans and Pricing

Patent: 160032266
Estimated Expiration: See Plans and Pricing

Spain

Patent: 39861
Estimated Expiration: See Plans and Pricing

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
Czech Republic 290772 Farmaceutický přípravek (Pharmaceutical preparation) See Plans and Pricing
Israel 111345 See Plans and Pricing
Poland 181462 See Plans and Pricing
Eurasian Patent Organization 022849 ЭМУЛЬСИОННЫЕ КОМПОЗИЦИИ КЛЕВИДИПИНА, СОДЕРЖАЩИЕ ПРОТИВОМИКРОБНЫЕ АГЕНТЫ (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS) See Plans and Pricing
Japan 3759951 See Plans and Pricing
China 1072934 See Plans and Pricing
Portugal 2627173 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CLEVIPREX

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