clevidipine - Profile

What are the generic 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.

Summary for clevidipine

International Patents:	26
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for clevidipine

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

Constraining patent/regulatory exclusivity:

8,658,676

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.

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	8,658,676		Y
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-001	Aug 1, 2008		RX	Yes	Yes	10,010,537		Y
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-001	Aug 1, 2008		RX	Yes	Yes	11,103,490		Y

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	5,739,152
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-001	Aug 1, 2008	5,739,152
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-003	Nov 8, 2013	5,739,152

International Patents for clevidipine

Country	Patent Number	Title	Estimated Expiration
Poland	2627173
Spain	2539861
World Intellectual Property Organization (WIPO)	2012051116

Supplementary Protection Certificates for clevidipine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	12C0053	France		PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: GB - PL 16881/0003 20111123

Analysis of the Investment Scenario, Market Dynamics, and Financial Trajectory for Clevidipine

Last updated: February 3, 2026

Summary

Clevidipine, an injectable dihydropyridine calcium channel blocker used primarily for acute hypertensive crises and perioperative blood pressure control, presents a niche but growing market opportunity. Its market dynamics are shaped by hypertension treatment trends, regulatory environments, and competitive alternatives. With a projected compound annual growth rate (CAGR) of approximately 4–6% over the next five years, clevidipine's financial trajectory hinges on patent exclusivity, pharmaceutical adoption, and evolving clinical guidelines.

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Overview of Clevidipine

Attribute	Description
Therapeutic Class	Selective arterial vasodilator (calcium channel blocker)
Formulation	Lipid emulsion (intravenous)
Approved Indications	Hypertensive crisis, perioperative hypertension
Regulatory Status	FDA-approved (U.S.), EMA approval (EU)
Patent / Exclusivity Status	Patent expiry in late 2020s; no current exclusivity extensions

Source: [1], [2]

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Market Size and Growth Projections

Current Market Landscape (2023)

Parameter	Value	Notes
Global Acute Hypertension Market	~$2.4 billion	Estimated (Fortune Business Insights, 2022)
Clevidipine's Share	~15%	Approximate, due to niche use cases
Major Competitors	Nicardipine, labetalol, esmolol

Forecast Future Market Growth (2023–2028)

Year	Market Projection	Compound Annual Growth Rate (CAGR)
2023	~$2.4 billion	Base
2028	~$3.0 billion	4.9% (average)

Analysis: The hypertensive crisis management market is expected to grow driven by increasing incidence of hypertension globally, aging populations, and improved critical care protocols.

Market Segment Breakdown

Segment	Estimated Market Share	CAGR (2023–2028)	Notes
Clevidipine	15–20%	~4.5%	Niche but stable segment
Nicardipine	40%	4%	Leading alternative
Labetalol & Esmolol	40%+	5%	Use in alternative scenarios, broad indications

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Investment Scenario Analysis

Factors Influencing Investment Attractiveness

Factor	Impact	Details
Patent Status	Negative	Patent expiration expected by 2024–2026 reduces exclusivity
Pricing Power	Limited	Price pressures due to generic competition
Clinical Adoption	Growing	New guidelines favor intravenous vasodilators in emergencies
Competitive Landscape	Intensifying	Multiple generics, alternative drugs
Regulatory Environment	Stable	Clear pathways, potential for new indications

Market Risks

• Patent Expiry: Diminished pricing power and increased generic competition post-2026.
• Pricing Pressure: Healthcare systems' cost containment strategies.
• Clinical Preference Shift: Adoption of alternative therapies and device-based blood pressure management.
• Supply Chain Constraints: Lipid emulsion manufacturing quality and stability.

Opportunities

• Expanded Indications: Potential for new approvals in related hypertensive conditions.
• Formulation Innovations: Development of sustained-release or combination therapies.
• Geographic Expansion: Emerging markets gaining access to intravenous hypertensive agents.
• Partnerships & Licensing: Collaborations with generic manufacturers or regional distributors.

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Financial Trajectory Projections (2023–2030)

Year	Revenue Estimate	EBITDA Margin	R&D/Marketing Expenses	Net Income	Key Assumptions
2023	~$150–200 million	20–25%	Moderate	$30–50 million	Steady adoption, post-patent expiry
2025	~$120–180 million	15–22%	Increased	$15–30 million	Price competition, generic entries
2028	~$80–130 million	10–18%	High (pipeline investment)	Break-even or slight profit	Market penetration stabilizes
2030	Potential decline or stabilization	Lower margins	Cost containment	Near-zero or negative	Patent expiry effects materialize

Note: These projections are speculative and subject to regulatory, competitive, and clinical factors.

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Comparative Analysis: Clevidipine vs. Alternatives

Parameter	Clevidipine	Nicardipine	Labetalol	Esmolol
Onset of Action	Rapid (2–4 min)	Rapid (5–15 min)	Fast (~5 min)	Rapid (2–5 min)
Duration	Short (15 min)	Moderate (30–60 min)	Moderate	Short
Formulation	Lipid emulsion	Tablet/IV	IV	IV
Efficacy	High	High	High	High
Cost	Higher (pre-generic)	Moderate	Lower	Moderate
Patent Status	Approved, patent expiry upcoming	Generic available	Generic available	Generic available

Implication: Clevidipine holds competitive advantages in rapid-onset, short-duration settings but faces pricing pressures post-patent expiry.

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Regulatory and Policy Factors

• FDA and EMA Approvals: Support for rapid hypertensive crisis management.
• Reimbursement Policies: Coverage varies; hospital formularies influence prescribing.
• Generic Entry: Expected after patent expiration, reducing revenue.

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Comparison with Other Injectable Vasodilators

Aspect	Clevidipine	Nicardipine	Fenoldopam
Marketed By	Multiple generic manufacturers	Multiple	Specialty drug, limited market
Indications	Hypertensive emergencies	Hypertensive emergencies	Hypertensive emergencies, renal protection
Pricing	Premium (pre-generic)	Moderate	High

Observation: The space is highly commoditized post-patent expiry, emphasizing the importance of clinical differentiation and formulary positioning.

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FAQs

1. What are the key factors influencing clevidipine’s market growth?
Market growth depends on clinical guidelines adoption, incidence of hypertensive crises, regulatory approvals of new indications, and the competitive landscape, especially post-patent expiry.

2. How will patent expiry affect clevidipine’s revenues?
Patent expiry will likely lead to increased generic competition, driving down prices and reducing margins, unless the manufacturer develops differentiated formulations or new indications.

3. Are new clinical guidelines favoring clevidipine?
Recent guidelines increasingly recommend intravenous vasodilators like clevidipine for hypertensive emergencies, especially for rapid control, which supports ongoing clinical use.

4. What are the main competitive threats?
Generic versions of nicardipine and labetalol, along with emerging alternative drugs and device-based blood pressure management, threaten market share.

5. How can investors mitigate risks associated with clevidipine’s market decline?
Investors should monitor regulatory developments, pipeline innovations, potential for new indications, and geographic expansion opportunities.

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Key Takeaways

• Market Position: Clevidipine dominates a niche market for rapid, short-term blood pressure control in acute settings but faces imminent patent expiry.
• Growth Outlook: Moderate growth projected (~4–6% CAGR) driven by clinical practice trends; however, revenue prospects diminish post-patent expiry.
• Competitive Dynamics: Increased generic competition will pressure prices and margins; differentiation strategies are crucial.
• Financial Considerations: Revenue decline anticipated post-2024, emphasizing the need for pipeline development and geographic expansion.
• Strategic Implication: Early investment in innovation, pipeline diversification, and strategic alliances can buffer the impact of patent expiration.

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References

[1] Fortune Business Insights. Global Hypertensive Crisis Management Market Report, 2022.
[2] U.S. Food and Drug Administration (FDA). Clevidipine Injection Approval Documents, 2010.