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.

The generic ingredient in CLEVIPREX is clevidipine. There is one drug master file entry 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

US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	15
Patent Applications:	1,372
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

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.

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			Y
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-003	Nov 8, 2013		DISCN	Yes	No			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
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

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
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	022156-001	Aug 1, 2008
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008

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
Australia	2011313852
Brazil	112013008601
Canada	2814495
China	103237446
Denmark	2627173
Eurasian Patent Organization	022849
Eurasian Patent Organization	201390541

Supplementary Protection Certificates for CLEVIPREX

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	1290008-0	Sweden		PRODUCT NAME: CLEVIDIPINE; NAT. REG. NO/DATE: 42321 20120120; FIRST REG.: GB PL 16881/0003 20111123
0726894	C00726894/01	Switzerland		PRODUCT NAME: RACEMISCHES CLEVIDIPINBUTYRAT; REGISTRATION NO/DATE: SWISSMEDIC 60117 11.06.2010
0726894	12C0053	France		PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: 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	SPC/GB12/011	United Kingdom		PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123

Last updated: July 19, 2026

CLEVIPREX (clevidipine) Market Dynamics and Financial Trajectory: Exclusivity, Competition, and Revenue Outlook

Executive summary: CLEVIPREX (clevidipine) is an IV, short-acting calcium channel blocker used for rapid blood pressure control in perioperative and hypertensive emergency settings. Its market is driven by hospital utilization patterns (ICU, perioperative anesthesia, stroke/critical care), formulary access, and substitution risk from other IV antihypertensives. Financial trajectory is shaped by (1) the maturity of clevidipine’s clinical positioning versus entrenched comparators, (2) pricing pressure from payer formularies and hospital contracting, and (3) the pathway for generic or lower-cost equivalents depending on Orange Book/patent status at the drug and formulation levels.

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What is CLEVIPREX (clevidipine) used for and how does that shape hospital demand?

Core indications and clinical use

• CLEVIPREX is used for rapid reduction of blood pressure in:
  • perioperative hypertension, and
  • hypertensive emergencies.
• The value proposition is fast titration and quick offset due to clevidipine’s pharmacokinetics, supporting use where clinicians want tight control without prolonged hypotension risk.

Where demand concentrates

• ICU and step-down units managing acute BP control protocols.
• Operating rooms and post-anesthesia care where anesthesia teams implement perioperative hypertension algorithms.
• Stroke/neurologic critical care pathways when “rapid, titratable” BP control is needed.

Demand drivers

• Protocolization: hospitals implement IV antihypertensive order sets for rapid titration, which can stabilize volume for favored agents.
• Staff familiarity: anesthesia/ICU practice patterns often keep a small set of “standard” IV agents stocked.
• Monitored use: clevidipine use requires close BP monitoring, aligning adoption with high-acuity settings rather than outpatient demand.

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How does CLEVIPREX compete against other IV antihypertensives in hospital formularies?

Primary competitive set (therapeutic class and functionality)

• Short-acting IV agents used for titratable BP control include:
  • nicardipine IV,
  • clevidipine’s direct “fast titration” comparator concept,
  • nitroprusside (historically common, with safety constraints),
  • esmolol (rate control context, but sometimes used in perioperative settings),
  • labetalol (IV bolus/infusion protocols in some hospitals),
  • hydralazine (less preferred in titration-dependent protocols, varies by institution).

What wins formularies

• Clinical protocol fit: institutions choose drugs that match their BP targets, monitoring systems, and clinician training.
• Safety profile: agent-specific adverse event considerations influence switching.
• Supply reliability and contracting: hospital purchasing contracts can shift volume even if clinical performance is similar.

Switching dynamics

• In many hospitals, clevidipine is one of a “menu” of titratable agents; switching tends to occur when:
  • another agent gets preferred formulary placement,
  • pricing gaps widen,
  • guideline or institutional protocol updates change titration preferences.

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When does CLEVIPREX lose exclusivity and when can generics enter?

Answer in business terms

• The timing of generic/market entry risk depends on:
  • whether CLEVIPREX has enforceable patents listed in the FDA Orange Book for the approved product and key claim families (composition, formulation, and method-of-use),
  • whether those patents expire first or are protected by pediatric exclusivity or other regulatory exclusivity extensions,
  • whether the product’s label and manufacturing process generate residual barriers (e.g., data exclusivity for specific aspects, or formulation/method patents).

Exclusivity framework that determines launch windows

• Patent expiry: drives Paragraph IV (Hatch-Waxman) incentives for ANDA filers.
• Regulatory exclusivity: can delay generic approvals independent of patent expiry.
• Patent “blocking”: even if some patents expire, remaining listed patents can still block approval for a generic until they expire or are designed around.

Practical market impact

• If no enforceable listed patents remain, generic entry can compress pricing and shift volume quickly in hospital contracts that support substitution.
• If patents remain strong around the product’s key claims, generic entry timing can slip and litigation costs rise, often limiting near-term competitive impact.

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What patents protect CLEVIPREX and how many barriers exist to generic substitution?

How barrier counts typically map to risk

• Generic risk is higher when the listed estate is small and claim scope is narrow.
• Generic risk is lower when there are multiple, overlapping patent families covering:
  • drug substance/composition,
  • specific formulation or excipients,
  • method of use tied to rapid titration protocols or perioperative/hypertensive emergency use,
  • manufacturing/process steps.

What to look for in the Orange Book listing

• Number of Orange Book patents listed for CLEVIPREX (product-level list).
• Patent term end dates.
• Patent claim type (method-of-use vs composition vs formulation).
• Whether multiple patents share a similar expiration window, creating a “single cliff” for entry, or whether they extend protection across several years.

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What is the Orange Book status of CLEVIPREX and what does it mean for ANDA Paragraph IV challenges?

Orange Book mechanics that drive market timing

• An ANDA that includes a Paragraph IV certification asserts non-infringement and/or invalidity for one or more Orange Book-listed patents.
• Patent litigation typically follows; settlements often include “design-around” terms, launch date covenants, or brand/non-brand exclusivity agreements.

Market implication

• If CLEVIPREX has active, late-expiring listed patents, Paragraph IV events are delayed and fewer challengers file.
• If CLEVIPREX’s listed patents are near expiration, the market usually sees:
  • increased ANDA filing activity,
  • heightened settlement frequency,
  • rapid price competition after court outcomes or settlements.

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What CLEVIPREX patent litigation affects competitors and potential generic entry?

How litigation changes competitive outcomes

• Court decisions or settlements can:
  • delay generic approval dates,
  • narrow label or dosing claims,
  • force design-around formulation changes,
  • lead to work-sharing and generic launch at a revised timing.

Typical settlement patterns

• Payment-for-delay type settlements are less common in some later periods, but covenants to refrain from launch until patent expiry remain a standard mechanism.
• Label restrictions can reduce substitution in the exact clinical scenarios that create brand strength (perioperative vs hypertensive emergencies, or specific BP target titration language).

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What formulations of clevidipine are protected, and do they create “design-around” opportunities?

Formulation barriers that affect substitutability

• IV formulation patents can cover:
  • excipient systems,
  • emulsions or delivery vehicles,
  • preparation or reconstitution steps,
  • stability constraints that affect shelf life and dosing.
• If formulation barriers exist, generics may still need bioequivalence and manufacturing controls that preserve comparable performance, increasing cost and execution risk.

Design-around logic

• If a generic can change excipients or manufacturing process without infringing, it may enter sooner even if some method claims remain active.
• If formulation is broadly claimed, design-around can be blocked, extending effective exclusivity.

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How do clinical outcomes, titration speed, and safety profile influence CLEVIPREX pricing power?

Clinical adoption and pricing

• When clinicians treat a drug as protocol-critical for rapid BP control, formulary stakeholders tolerate higher acquisition costs if outcomes or workflow improve.
• If comparable IV agents offer similar titration performance at lower acquisition cost, hospitals negotiate down.

Safety-driven prescribing

• Any adverse event profile that drives monitoring time, infusion interruptions, or switching can affect net utilization.
• Conversely, if clevidipine protocols reduce prolonged hypotension risk compared with alternatives in practice, hospitals may keep it despite price pressure.

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What is the revenue trajectory for CLEVIPREX: growth phases, maturity, and erosion risk?

Trajectory drivers

• Brand maturity: as a drug becomes established, growth tends to stabilize unless:
  • new indications expand use,
  • new sites adopt clevidipine protocols,
  • competitor outages reduce substitution.
• Erosion risk: price and volume pressure increases when:
  • alternative IV agents gain preferred formulary status,
  • contracting shifts from open-market pricing to bundled or GPO-negotiated pricing,
  • generics or authorized generics approach.

Financial endpoints to monitor

• Net sales: affected by
  • unit demand (number of infusions),
  • average net price after rebates/discounts,
  • mix shifts between perioperative and emergency use.
• Gross margin: affected by
  • manufacturing costs,
  • commercial discounting intensity,
  • inventory management pre- and post-competitive events.

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How does hospital contracting influence CLEVIPREX unit economics?

Contracting mechanism

• Hospital systems negotiate IV antihypertensive portfolios via contracting committees, GPO pricing, and PBM-like structures for institutional purchasing.
• For “rapid titration” agents, systems often standardize a small set to simplify training and reduce pharmacy management burden.

What changes in contracting

• Preferential placement of alternative agents can reduce clevidipine volume even if clinical use remains appropriate.
• Contract renegotiations often occur on a recurring schedule, creating periodic sales volatility.

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What generic entry risks exist for CLEVIPREX and how fast would competition likely hit?

Generic entry risk profile

• Higher risk when:
  • Orange Book patent list is small,
  • late-expiring patents do not exist,
  • formulation claims are weak or easy to design around.
• Lower risk when:
  • multiple listed patents span different expiry dates,
  • formulation/method patents are broad,
  • litigation historically has been active.

Speed of market impact

• Hospitals can shift to lower-cost alternatives quickly once FDA approval occurs and contracting allows substitution.
• If substitution is protocol-driven, volume can migrate within a single contracting cycle after a competitive price is established.

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How does CLEVIPREX compare with nicardipine IV and labetalol in commercial competitiveness?

Comparison logic used by procurement

• Administration workflow: infusion setup complexity and monitoring demands.
• Acquisition cost and rebate structure: key to net price.
• Protocol fit: whether existing perioperative pathways default to nicardipine/labetalol versus clevidipine.

Competitive outcome

• CLEVIPREX’s commercial strength is typically supported when:
  • clinical teams rely on its titration profile,
  • pharmacy committees perceive fewer protocol failures and fewer infusion discontinuations.
• Its competitive weakness emerges when:
  • contracting favors cheaper alternatives,
  • clinicians broaden their “first-line” menu to include other IV titratables.

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What does the competitive landscape look like at launch and during price compression?

Before competition

• Brand share is supported by:
  • entrenched hospital protocols,
  • prescriber preference,
  • supply reliability and pharmacy familiarity.

During competition

• Price compression tends to be concentrated in:
  • high-volume perioperative centers,
  • systems with standardized formularies that can switch quickly.

After competition

• Brand volume typically declines with generic or alternative uptake unless:
  • brand retains preferred status through contracting,
  • authorized generics reduce price gaps,
  • label or protocol language restrict substitution.

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Key patents, exclusivity, and timing: what to model for CLEVIPREX financial forecasts

Model variables

• Orange Book: number of listed patents and their individual expiration dates.
• Pediatric exclusivity and any other regulatory exclusivity extensions.
• Likelihood of ANDA Paragraph IV challenges (based on patent strength and claim scope).
• Litigation timelines and settlement terms that can shift launch timing.

Forecast shape

• Base case: continued brand maturity with gradual price erosion and modest volume changes tied to contracting cycles.
• Downside case: generic entry event triggers faster unit declines and sharp net price compression.
• Upside case: entry delayed by remaining patent estate and/or market substitution slower than expected due to protocol lock-in.

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Key Takeaways

• CLEVIPREX demand is anchored in hospital perioperative and ICU protocols for rapid, titratable blood pressure control, making its market largely institutional.
• Competitive pressure is driven less by clinical differentiation alone and more by formulary placement and hospital contracting dynamics.
• The financial trajectory is most sensitive to Orange Book patent estate strength, expiration timing, and any Paragraph IV/litigation outcomes that determine generic entry.
• Generic substitution can be swift at scale once approval and contracting align, typically causing material net price and volume erosion.

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FAQs

1. What hospital units use CLEVIPREX most and how does that affect sales seasonality?
2. How do rebates and hospital contracting typically change CLEVIPREX net price over time?
3. What is the most likely competitive trigger for CLEVIPREX volume loss: formulary switch, pricing, or generic entry?
4. How do Orange Book formulation or method-of-use patents influence design-around strategies for ANDA filers?
5. What label restrictions in litigation settlements most affect CLEVIPREX substitution in perioperative care?

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. Hatch-Waxman Act information and Paragraph IV certification framework. U.S. Food and Drug Administration. https://www.fda.gov/

DrugChatter Q&A for CLEVIPREX

What is cleviprex used for?