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Last Updated: November 29, 2022

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
Recent Clinical Trials for clevidipine

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

SponsorPhase
ProMedica Health SystemPhase 3
Shenzhen People's HospitalPhase 3
Nanjing Yoko Biomedical Co., Ltd.Phase 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 022156-001 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 022156-001 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 022156-002 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 clevidipine

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 022156-002 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 022156-001 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 022156-001 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 clevidipine

Country Patent Number Title Estimated Expiration
Australia 2011313852 Clevidipine emulsion formulations containing antimicrobial agents See Plans and Pricing
South Korea 20130101080 CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS See Plans and Pricing
Japan 6326094 See Plans and Pricing
Japan 6040437 See Plans and Pricing
Hungary E026295 See Plans and Pricing
Japan 6437743 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for clevidipine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0726894 C300520 Netherlands See Plans and Pricing PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: RVG 104771 20111129; FIRST REGISTRATION: 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 92209 Luxembourg See Plans and Pricing PRODUCT NAME: CLEVIDIPINE SOUS TOUTES LES FORMES PROCURANT UNE PROTECTION A PARTIR DU BREVET DE BASE
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Colorcon
McKesson

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