Clevidipine - Generic Drug Details

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What are the generic drug sources for clevidipine and what is the scope of freedom to operate?

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

International Patents:	26
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	27
Patent Applications:	1,263
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for clevidipine
What excipients (inactive ingredients) are in clevidipine?	clevidipine excipients list
DailyMed Link:	clevidipine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for clevidipine

Generic Entry Date for clevidipine^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
University of California, San Diego	Phase 4
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Phase 3
ProMedica Health System	Phase 3

See all clevidipine clinical trials

Pharmacology for clevidipine

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for clevidipine

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

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

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Glossary

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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
>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

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for clevidipine

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Country	Patent Number	Title	Estimated Expiration
Mexico	356537	FORMULACIONES DE EMULSION DE CLEVIDIPINA QUE CONTIENEN AGENTES ANTIMICROBIANOS. (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS.)	⤷ Sign Up
Mexico	2013004151	FORMULACIONES DE EMULSION DE CLEVIDIPINA QUE CONTIENEN AGENTES ANTIMICROBIANOS. (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS.)	⤷ Sign Up
Denmark	2627173		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for clevidipine

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0726894	1290008-0	Sweden	⤷ Sign Up	PRODUCT NAME: CLEVIDIPINE; NAT. REG. NO/DATE: 42321 20120120; FIRST REG.: 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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