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Last Updated: March 4, 2024

Clevidipine - Generic Drug Details


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What are the generic drug sources for clevidipine and what is the scope of patent protection?

Clevidipine is the generic ingredient in one branded drug marketed by Chiesi and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Clevidipine has twenty-six patent family members in seventeen countries.

There are three drug master file entries for clevidipine. Two suppliers are listed for this compound.

Summary for clevidipine
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for clevidipine
Generic Entry Date for clevidipine*:
Constraining patent/regulatory exclusivity:
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 clevidipine

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

SponsorPhase
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Phase 3
ProMedica Health SystemPhase 3
Shenzhen People's HospitalPhase 3

See all clevidipine clinical trials

Pharmacology for clevidipine
Paragraph IV (Patent) Challenges for CLEVIDIPINE
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 clevidipine

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

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

International Patents for clevidipine

Country Patent Number Title Estimated Expiration
Hungary E026295 ⤷  Try a Trial
Portugal 2627173 ⤷  Try a Trial
Spain 2539861 ⤷  Try a Trial
Canada 2814495 PREPARATIONS DE CLEVIDIPINE EN EMULSION CONTENANT DES AGENTS ANTIMICROBIENS (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS) ⤷  Try a Trial
South Korea 20130101080 CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS ⤷  Try a Trial
Japan 6040437 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for clevidipine

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