CLEVIDIPINE - Generic Drug Details

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

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	022156-002	Aug 1, 2008		RX	Yes	Yes			Y
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-001	Aug 1, 2008		RX	Yes	Yes			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	022156-003	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	022156-003	Nov 8, 2013
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008

International Patents for CLEVIDIPINE

Country	Patent Number	Title	Estimated Expiration
Hungary	E026295
Eurasian Patent Organization	201390541
Japan	6326094
Hong Kong	1187495	含有抗微生物劑的氯維地平乳劑製劑 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Mexico	356537	FORMULACIONES DE EMULSION DE CLEVIDIPINA QUE CONTIENEN AGENTES ANTIMICROBIANOS. (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS.)

Supplementary Protection Certificates for CLEVIDIPINE

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

Market Dynamics and Financial Trajectory of Clevidipine

Last updated: February 13, 2026

Clevidipine is an intravenous (IV) dihydropyridine calcium channel blocker indicated for acute hypertension and perioperative blood pressure control. Approved by the FDA in 2008 under brand name Cleviprex, it has a targeted market primarily in hospital and critical care settings.

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Market Size and Growth Drivers

Global Market Estimate

As of 2022, the global intravenous antihypertensive drugs market was valued at approximately $1.2 billion. Clevidipine holds a fractional share but is considered significant within the niche of rapidly acting IV antihypertensives.

Market Penetration Factors

• Clinical Preference: Clevidipine is favored over alternatives such as nicardipine or labetalol for its rapid onset and short half-life.
• Physician Adoption: Limited to hospitals equipped for IV infusion; requires specialized administration.
• Regulatory Environment: Post-approval, it has faced restricted labeling in some regions (e.g., EU), limiting geographic expansion.

Market Growth Drivers

• Increasing prevalence of perioperative hypertension.
• Growing demand for fast-acting blood pressure management solutions in critical care.
• Adoption in surgical settings and hypertensive emergencies.
• Rising surgical volumes globally, especially in Asia-Pacific.

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Competitive Landscape

Competitors	Market Share	Key Attributes
Nicardipine (cardene)	Largest	Longer half-life, more administration flexibility
Labetalol	Significant	Oral and IV options, broader indications
Clevidipine	Niche player	Rapid action, short half-life, infusion control

Clevidipine's unique pharmacokinetic profile diminishes exposure duration, which reduces hypotension risk and makes it suitable for specific clinical scenarios where rapid titration is necessary.

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Regulatory and Reimbursement Factors

• FDA Approval: 2008; considerations included safety profile and administration protocols.
• Market Access: Restricted in some countries due to concerns over lipid emulsion formulation and potential injection site risks.
• Reimbursement: Generally covered under hospital outpatient and inpatient services, though cost considerations limit widespread use.

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Financial Trajectory and Revenue Trends

Historical Revenue Data

• Initial Launch: Estimated at $50 million in 2008.
• 2012-2015: Revenue stabilization around $70 million annually.
• Post-2015: Slight decline attributed to competition and restricted usage.

Current Revenue Outlook

• As of 2022, annual sales estimated between $40 million to $50 million in the U.S.
• Marginal growth expected if regulatory hurdles are addressed and adoption expands in Asia-Pacific.

Pricing and Cost Structure

• Average Price: About $150-$200 per vial in the U.S.
• Cost Factors:
  • Manufacturing complexity due to lipid emulsion formulation.
  • Distribution costs tied to hospital-based use.
  • R&D costs amortized over product life, with ongoing post-marketing commitments.

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Market Challenges and Opportunities

Challenges

• Limited to hospital settings; does not serve outpatient markets.
• Competition from oral antihypertensives for post-stabilization management.
• Regulatory restrictions that vary by region.

Opportunities

• Expansion in emerging markets with increasing surgical volumes.
• Potential label updates for broader indications.
• Strategic partnerships to improve manufacturing efficiency and global distribution.

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Future Outlook and Strategic Considerations

The outlook hinges on regulatory developments and clinical advocacy. Companies could focus on:

• Conducting new clinical trials to demonstrate benefits over competitors in specific populations.
• Targeting high-acuity hospital settings, emphasizing the rapid onset and short duration.
• Addressing regulatory restrictions in Europe and other regions through data submissions.

Revenue projection remains modest unless broader adoption is realized; growth rates are expected to be under 5% annually unless significant market expansion occurs.

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Key Takeaways

• Clevidipine operates within a niche of IV antihypertensive drugs, primarily in hospital settings.
• Market size in 2022 is approximately $50 million in the U.S., with limited global penetration.
• Competition from nicardipine and labetalol influences sales, with price points around $150-$200 per vial.
• Growth opportunities depend on regulatory access, clinical benefits, and geographic expansion.
• Revenue stability currently relies on hospital-based prescriptions, with growth prospects tied to new clinical data and market expansion efforts.

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FAQs

1. What are the primary clinical advantages of clevidipine?
It provides rapid blood pressure control with a short half-life, enabling precise titration and minimizing hypotension risk, making it ideal for critical care and perioperative use.

2. How does clevidipine compare to nicardipine?
Clevidipine has a shorter half-life (about 1 minute) versus nicardipine (which lasts several hours), allowing faster titration. Nicardipine can be more suitable for prolonged infusion scenarios.

3. What are the main regulatory challenges facing clevidipine?
Regulatory restrictions exist in some markets due to lipid emulsion formulation concerns and infusion site reactions, limiting broader international use.

4. Can clevidipine be used outside hospital settings?
No. Its administration requires specialized infusion equipment and monitoring, restricting use to hospital facilities.

5. Are there potential future indications for clevidipine?
While currently limited to hypertension management, research may explore additional indications such as use in hypertensive crises or neurocritical care, contingent on clinical trial evidence.

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References

1. MarketWatch. (2022). "Intravenous antihypertensive drugs market size, share, growth."
2. FDA. (2008). "Approval letter for Cleviprex (clevidipine)."
3. EvaluatePharma. (2022). "Pharmaceutical sales data."
4. GlobalData Healthcare. (2022). "Market analysis: IV antihypertensive drugs."
5. Epocrates. (2022). "Clinical use and pharmacokinetics of clevidipine."