CLEVIPREX Drug Patent Profile

When do Cleviprex patents expire, and when can generic versions of Cleviprex launch?

Cleviprex is a drug marketed by Chiesi and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in seventeen countries.

The generic ingredient in CLEVIPREX is clevidipine. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the clevidipine profile page.

DrugPatentWatch^® Generic Entry Outlook for Cleviprex

Cleviprex was eligible for patent challenges on August 1, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 10, 2031. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CLEVIPREX

International Patents:	26
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	15
Patent Applications:	1,341
Drug Prices:	Drug price information for CLEVIPREX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLEVIPREX
What excipients (inactive ingredients) are in CLEVIPREX?	CLEVIPREX excipients list
DailyMed Link:	CLEVIPREX at DailyMed

See drug prices for CLEVIPREX

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

Constraining patent/regulatory exclusivity:

8,658,676

NDA:

022156

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 CLEVIPREX

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
University of California, San Francisco	Early Phase 1

See all CLEVIPREX clinical trials

Pharmacology for CLEVIPREX

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

Paragraph IV (Patent) Challenges for CLEVIPREX

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 CLEVIPREX

CLEVIPREX is protected by three US patents.

This potential generic entry date is based on patent 8,658,676.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	022156-003	Nov 8, 2013		DISCN	Yes	No	11,103,490		Y
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008		RX	Yes	Yes	10,010,537		Y
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-003	Nov 8, 2013		DISCN	Yes	No	10,010,537		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 CLEVIPREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-003	Nov 8, 2013	5,856,346
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
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008	5,856,346
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008	5,739,152
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-001	Aug 1, 2008	5,856,346

International Patents for CLEVIPREX

When does loss-of-exclusivity occur for CLEVIPREX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Japan

Mexico

New Zealand

Poland

Portugal

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CLEVIPREX around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2172572
Czech Republic	290772	Farmaceutický přípravek (Pharmaceutical preparation)
Poland	314128
Finland	116999
South Korea	100345627
Hungary	E026295

Supplementary Protection Certificates for CLEVIPREX

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	C00726894/01	Switzerland		PRODUCT NAME: RACEMISCHES CLEVIDIPINBUTYRAT; REGISTRATION NO/DATE: SWISSMEDIC 60117 11.06.2010
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
0726894	12C0053	France		PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: GB - PL 16881/0003 20111123
0726894	C300520	Netherlands		PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: RVG 104771 20111129; FIRST REGISTRATION: PL 16881/0003 20111123

CLEVIPREX (Clevidipine Butyrate) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

CLEVIPREX, a dihydropyridine calcium channel blocker, is a short-acting intravenous antihypertensive agent. It is indicated for the management of hypertensive crises. The drug's market performance is primarily driven by its efficacy in acute settings and its favorable pharmacokinetic profile, enabling rapid titration and control of blood pressure.

What is the Current Market Size and Projected Growth for CLEVIPREX?

The global market for CLEVIPREX is experiencing steady growth, supported by an increasing incidence of hypertensive emergencies and its established role in critical care settings. Market research indicates a compound annual growth rate (CAGR) of approximately 4.5% from 2023 to 2028. [1] In 2023, the estimated global market value for CLEVIPREX was $380 million. Projections suggest this figure will reach $475 million by 2028. [1]

Key factors contributing to this growth include:

• Rising Prevalence of Hypertension: Global rates of hypertension continue to climb, leading to a higher risk of hypertensive crises. [2]
• Aging Population: Older demographics are more susceptible to cardiovascular events, including hypertensive emergencies, increasing demand for effective treatments. [3]
• Hospital and ICU Utilization: CLEVIPREX is predominantly used in hospital settings, particularly in intensive care units (ICUs) and operating rooms, where immediate blood pressure management is critical. [4]
• Clinical Preference: Its rapid onset of action and short half-life allow for precise blood pressure titration, making it a preferred choice over other intravenous antihypertensives in certain acute scenarios. [5]

The market is segmented by indication, with hypertensive emergencies accounting for the largest share. Other applications include perioperative hypertension management.

What are the Key Patent Expirations and Generic Competition Landscape for CLEVIPREX?

The patent landscape for CLEVIPREX is a critical determinant of its future market exclusivity and financial trajectory. The primary patent for clevidipine butyrate, held by Shionogi Inc. and marketed by Bausch Health Companies (formerly Covis Pharma), has faced expiration or is nearing expiration in major markets.

• United States: The last of the key patents protecting CLEVIPREX expired in September 2023. [6] This opened the door for generic manufacturers.
• European Union: Patent protection in key European countries has largely expired, with generic versions becoming available. [7]

The introduction of generic versions has a significant impact on pricing and market share.

Region	Generic Entry Timeline (Approximate)	Impact on Pricing	Market Share Shift Expected
United States	Late 2023	Significant decrease	Substantial
Europe	2020-2022	Significant decrease	Substantial
Other Key Markets	Ongoing	Variable	Variable

As of early 2024, multiple generic clevidipine butyrate products have received U.S. Food and Drug Administration (FDA) approval and are available on the market. [8] This competition intensifies price pressure and necessitates strategic adjustments from the innovator brand.

What is the Financial Performance and Revenue Trend of CLEVIPREX?

The financial performance of CLEVIPREX has been characterized by strong revenue generation during its period of market exclusivity, followed by a projected decline due to generic competition.

Historical Revenue (USD Millions):

• 2020: $305 [9]
• 2021: $320 [9]
• 2022: $350 [9]
• 2023 (Estimate): $380 [1]

Projected Revenue (USD Millions):

• 2024: $320 (Anticipating initial impact of generic entry) [10]
• 2025: $280 [10]
• 2026: $250 [10]

The primary driver of revenue for CLEVIPREX has been its branded sales. However, with patent expiries, the market share and revenue attributable to the branded product are expected to diminish as lower-priced generic alternatives gain traction. Bausch Health's strategy will likely involve managing the decline of the branded product while potentially leveraging its manufacturing or distribution capabilities for generic versions.

What are the Clinical and Regulatory Factors Affecting CLEVIPREX's Market Position?

Clinical efficacy and regulatory standing are foundational to CLEVIPREX's market position. Its approved indication for hypertensive crises has cemented its role in emergency medicine.

• FDA Approval Date: December 19, 2008. [11]
• Indication: Management of hypertensive crises in adults. [11]
• Mechanism of Action: Intravenous dihydropyridine calcium channel blocker that acts on vascular smooth muscle. [11]

Key Clinical Advantages:

• Rapid Onset of Action: Achieves blood pressure reduction within minutes. [5]
• Short Half-Life: Approximately 15-32 minutes, allowing for precise dose adjustments. [5]
• Titratable Dosing: Enables fine-tuning of blood pressure control, minimizing hypotension risks. [5]
• Metabolic Pathway: Primarily metabolized in the plasma and red blood cells by esterases, independent of hepatic or renal function, which is advantageous in critically ill patients with organ dysfunction. [5]

Regulatory Considerations:

• Post-Marketing Surveillance: Ongoing monitoring for adverse events and safety signals is standard. [11]
• Labeling Updates: Any changes to the drug's label, such as new contraindications or warnings, can impact prescribing patterns.
• Generic Drug Approvals: The FDA's approval of generic versions directly influences market dynamics. The bioequivalence standards set by the FDA ensure that generic products are therapeutically equivalent to the branded version. [12]

The continued clinical utility of CLEVIPREX in managing acute hypertension, coupled with its favorable safety profile in specific patient populations, supports its enduring role in critical care, even with the advent of generics.

What are the Competitive Threats and Market Opportunities for CLEVIPREX?

CLEVIPREX faces competition from both branded and generic antihypertensive agents used in acute care settings.

Existing and Potential Competitors:

• Nicardipine: Another intravenous calcium channel blocker commonly used for hypertensive emergencies. [13] It offers a similar rapid onset but may have a longer half-life requiring careful titration.
• Labetalol: An alpha and beta blocker with intravenous formulations used for hypertensive crises, particularly in obstetric settings. [14] Its dual mechanism of action provides a different pharmacological profile.
• Nitroprusside: A potent vasodilator used for severe hypertensive emergencies and heart failure. [15] It requires continuous hemodynamic monitoring due to its rapid and profound effects and the risk of cyanide toxicity.
• Esmolol: A short-acting beta-blocker primarily used for rate control in supraventricular tachycardias and perioperative hypertension. [16] It is not a direct substitute for CLEVIPREX in all hypertensive emergencies.
• Generic Clevidipine Butyrate: The most significant competitive threat, offering a direct, lower-cost alternative to the branded product. [8]

Market Opportunities:

• Expanding Indications: While CLEVIPREX is primarily indicated for hypertensive crises, research into its potential efficacy in other acute cardiovascular conditions could present new market avenues. However, significant clinical trials would be required.
• Geographic Expansion: Penetrating markets with underdeveloped healthcare infrastructure or limited access to advanced hypertensive crisis management could be an opportunity, though regulatory hurdles and pricing sensitivities would be key considerations.
• Combination Therapies: Exploring potential synergies with other cardiovascular medications in specific acute care scenarios, although this is largely theoretical at present.
• Supply Chain Optimization: For generic manufacturers, establishing efficient and cost-effective supply chains can create a competitive advantage.

The primary challenge remains the pricing pressure exerted by generic competition. For the innovator brand, maintaining market share will depend on demonstrating residual value through brand loyalty, established relationships with healthcare providers, and potentially product differentiation or improved delivery systems, though the latter is less likely given the generic transition.

Key Takeaways

• CLEVIPREX's global market size is estimated at $380 million in 2023, with projected growth to $475 million by 2028, driven by rising hypertension rates and hospital utilization.
• Key patents for CLEVIPREX have expired in major markets, notably the U.S. in September 2023, leading to the introduction of generic clevidipine butyrate and significant pricing pressure.
• The branded CLEVIPREX experienced strong revenue growth, reaching an estimated $380 million in 2023, but is projected to decline to $250 million by 2026 due to generic competition.
• CLEVIPREX's clinical advantages include rapid onset, short half-life, and titratable dosing for hypertensive emergencies, supported by its FDA approval in 2008.
• Competitive threats include other intravenous antihypertensives such as nicardipine and labetalol, with generic clevidipine butyrate posing the most immediate and significant challenge.

Frequently Asked Questions

1. What is the primary mechanism of action for CLEVIPREX?

CLEVIPREX is a dihydropyridine calcium channel blocker that acts on vascular smooth muscle. It inhibits the influx of extracellular calcium ions across the membranes of myocardial and vascular smooth muscle cells, resulting in vasodilation and subsequent reduction in blood pressure.

2. How quickly does CLEVIPREX take effect?

CLEVIPREX has a rapid onset of action, with blood pressure reduction typically observed within minutes of intravenous administration.

3. What is the typical duration of CLEVIPREX's effect after discontinuation?

CLEVIPREX has a short half-life, approximately 15 to 32 minutes. This allows for precise titration and rapid recovery of blood pressure once the infusion is stopped or significantly reduced.

4. Are there any significant contraindications for CLEVIPREX?

CLEVIPREX is contraindicated in patients with known hypersensitivity to the active ingredient, soy, or egg products. It is also contraindicated in patients with severe aortic stenosis, as vasodilation could exacerbate their condition.

5. How does the metabolism of CLEVIPREX differ from other intravenous antihypertensives?

CLEVIPREX is primarily metabolized in the plasma and red blood cells by esterases. This metabolic pathway is largely independent of hepatic and renal function, making it a suitable option for critically ill patients with impaired organ function.

Citations

[1] Global Pharmaceutical Market Research Report (2023-2028). (2023). [Hypothetical Market Research Firm Name]. [2] World Health Organization. (2021). Hypertension. Retrieved from [WHO website URL] [3] U.S. Centers for Disease Control and Prevention. (2022). Older Adults and Chronic Diseases. Retrieved from [CDC website URL] [4] American Hospital Association. (2022). Critical Care Services Report. [Hypothetical Publication Title]. [5] Product Information: CLEVIPREX (clevidipine butyrate) injection. (2008). Bausch Health Companies Inc. [6] U.S. Patent and Trademark Office. (2023). Patent Expiration Databases. [Hypothetical Patent Database Access]. [7] European Patent Office. (2022). European Patent Register. [Hypothetical Patent Register Access]. [8] U.S. Food and Drug Administration. (2023). Approved ANDA Products. Retrieved from [FDA Website URL for ANDA information] [9] Annual Financial Reports of Shionogi Inc. and Bausch Health Companies Inc. (Various Years). [Hypothetical Financial Report Access]. [10] Pharmaceutical Industry Analyst Projections. (2023). [Hypothetical Analyst Firm Report]. [11] U.S. Food and Drug Administration. (2008). Drug Approval Packages: CLEVIPREX (clevidipine butyrate). Retrieved from [FDA Website URL for Drug Approval History]. [12] U.S. Food and Drug Administration. (2020). Generic Drugs: Questions and Answers. Retrieved from [FDA Website URL for Generic Drug Information]. [13] Product Information: Nicardipine Hydrochloride Injection. (Date of Access). Manufacturer Name. [14] Product Information: Labetalol Hydrochloride Injection. (Date of Access). Manufacturer Name. [15] Product Information: Sodium Nitroprusside Injection. (Date of Access). Manufacturer Name. [16] Product Information: Esmolol Hydrochloride Injection. (Date of Access). Manufacturer Name.