Clevidipine - Generic Drug Details

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 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

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

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

Expired US Patents for clevidipine

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

International Patents for clevidipine

Country	Patent Number	Title	Estimated Expiration
Japan	2014196322	抗菌剤を含むクレビジピン乳化製剤 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Eurasian Patent Organization	022849	ЭМУЛЬСИОННЫЕ КОМПОЗИЦИИ КЛЕВИДИПИНА, СОДЕРЖАЩИЕ ПРОТИВОМИКРОБНЫЕ АГЕНТЫ (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
European Patent Office	2627173	PRÉPARATIONS DE CLÉVIDIPINE EN ÉMULSION CONTENANT DES AGENTS ANTIMICROBIENS (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
South Korea	20160032266	항미생물제를 함유하는 클레비디핀 에멀젼 제제 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Japan	2014504259
Denmark	2627173
Denmark	2627173

Supplementary Protection Certificates for clevidipine

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Clevidipine

Last updated: July 28, 2025

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Introduction

Clevidipine, a highly selective dihydropyridine calcium channel blocker, serves as an intravenous antihypertensive agent primarily indicated for acute hypertension management and perioperative blood pressure control. Since its approval by the U.S. Food and Drug Administration (FDA) in 2008, clevidipine’s market trajectory has been shaped by evolving clinical needs, regulatory landscapes, and competitive dynamics within the antihypertensive drug segment. This analysis explores the key drivers influencing its market growth and the financial outlook, underpinning strategic considerations for stakeholders.

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Market Overview and Demand Drivers

Medical Need and Clinical Utility

Clevidipine fills a critical niche in the management of severe hypertension, especially in hospital and critical care settings. Its rapid onset, short duration, and titratability make it preferable over traditional agents like sodium nitroprusside and nicardipine. The increasing prevalence of hypertension—affecting over 1.3 billion adults globally according to the World Health Organization—augments the demand for effective inpatient blood pressure control agents. Moreover, a trend toward precise hemodynamic management during surgery and ICU care bolsters clevidipine’s clinical utility.

Regulatory Environment and Adoption Barriers

Patented and approved primarily in the United States, the drug benefits from a well-defined regulatory framework that has facilitated its acceptance in hospital formularies. However, patent expiry scheduled around 2024 introduces potential generic competition, which could lower prices and impact margins. Additionally, rigorous hospital procurement processes and reimbursement structures influence market penetration.

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Competitive Landscape

Key Competitors

Clevidipine's principal competitors include:

• Nicardipine: An all-in-one alternative with a longer half-life, existing as a generic, thus offering a lower-cost option.
• Sodium Nitroprusside: Still used for rapid blood pressure reduction but associated with cyanide toxicity risks.
• Other emerging agents: Pharmacological innovations in hypertensive crisis management could challenge clevidipine’s market share.

Market Positioning and Differentiators

Clevidipine's exclusivity allows it to command premium pricing based on its safety profile, rapid titratability, and predictable pharmacokinetics. However, the relatively narrow scope of IV use limits widespread adoption outside critical care settings.

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Revenue Generation and Financial Trajectory

Historical Revenue Trends

Initially, annual sales of clevidipine in the U.S. peaked around $88 million in 2015 but experienced fluctuations owing to generic competition and formulary shifts. The drug remains a vital component within the hospitalized hypertensive control market, primarily within the high-acuity segments.

Impact of Patent Expiry and Generics

With patent expiration anticipated in 2024, the entry of generic competitors is imminent. Historically, patent cliffs result in significant price erosion—upward of 70% in some cases—leading to revenue declines for originators. Stakeholders must strategize around potential volume increases due to lower prices versus revenue dilution.

Emerging Markets and Global Revenue

Currently, clevidipine's market is concentrated in the U.S. with limited presence in emerging markets where healthcare budgets and regulatory pathways pose challenges. Expanding into these regions could diversify revenue streams but requires navigating local approval processes and establishing supply chains.

Potential for New Indications and Formulations

Research into expanding clevidipine’s indications—such as perioperative hypertensive crises or hypertensive emergencies—could bolster future revenues. Nevertheless, development costs and regulatory approvals entail considerable risk and timeframes.

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Market Trends and Forecasts

• Projected Growth: The global hospital antihypertensive drugs segment is expected to grow at a CAGR of approximately 4.2% from 2022 to 2030 [1]. Clevidipine's contribution will depend on formulary acceptance, pricing strategies, and generic competition management.
• Price Erosion Risks: Post-patent expiry, generic entry could precipitate a decline in average selling prices (ASPs) by up to 60-70%, impinging on profit margins.
• Innovation and Lifecycle Management: Developing fixed-dose combinations or novel delivery methods might extend product lifecycle value.

Strategic Implications for Stakeholders

• Pharma Manufacturers: Should focus on securing patents for new formulations or indications, reducing cost structures, and engaging in strategic partnerships.
• Investors: Need to monitor patent statuses and formulation pipelines to assess long-term revenue sustainability.
• Healthcare Providers: Must evaluate cost-effectiveness considering emerging generics and alternative therapies.

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Key Takeaways

• The demand for clevidipine is driven by its clinical advantages in critical care, amid a growing global hypertension burden.
• Patent expiration in 2024 is poised to catalyze significant market shifts, primarily due to the entry of generics and resultant price competition.
• Competitive positioning relies on differentiators such as safety profile, rapid onset, and hospital formulary access; these factors are critical amid evolving healthcare expenditure constraints.
• Expanding into emerging markets and pursuing new indications represent opportunities for revenue diversification but require strategic investments.
• Monitoring technological innovations and regulatory developments remains essential for estimating long-term financial trajectories.

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FAQs

1. What factors could affect clevidipine’s market share after patent expiry?
The entry of generic competitors will likely lead to substantial price reductions. Additionally, clinical practice shifts toward alternative agents or emerging therapies could influence prescribing behavior, impacting market share.

2. Is clevidipine approved outside the United States?
Currently, clevidipine’s approval is predominantly in the U.S. The drug faces regulatory and market access challenges in other countries, limiting its global footprint.

3. How does clevidipine compare cost-wise with its competitors?
As a branded, patented drug, clevidipine is generally priced higher than generic alternatives like nicardipine. Post-patent, prices are expected to decline, increasing competitive pressure.

4. Are there ongoing clinical trials to expand clevidipine’s indications?
Yes, some studies explore broader usage in hypertensive emergencies and during various perioperative settings; their outcomes could influence future adoption and revenue.

5. What strategies can pharmaceutical companies adopt to sustain profitability post-patent?
Diversification through new formulations, indications, or partnership-driven marketing, alongside cost optimization for manufacturing, can help maintain margins amid generic competition.

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References:

[1] Future Market Insights, "Hospital Antihypertensive Drugs Market Forecast," 2022.