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:	1,282
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

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	022156-002	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
Japan	2014196322	抗菌剤を含むクレビジピン乳化製剤 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Norway	961776
World Intellectual Property Organization (WIPO)	9513066

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	C00726894/01	Switzerland		PRODUCT NAME: RACEMISCHES CLEVIDIPINBUTYRAT; REGISTRATION NO/DATE: SWISSMEDIC 60117 11.06.2010
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: CLEVIPREX

Last updated: July 27, 2025

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Introduction

CLEVIPREX, a novel pharmaceutical agent, has garnered attention within the healthcare industry for its promising therapeutic profile. This analysis explores the evolving market landscape, anticipated financial trajectory, competitive positioning, and strategic considerations for stakeholders invested in or evaluating CLEVIPREX’s commercial potential. As a drug in a highly regulated sector, understanding the underlying market dynamics is crucial for making informed investment and development decisions.

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Market Overview

Indication Spectrum and Unmet Needs

CLEVIPREX is positioned within the domain of infectious disease therapeutics, specifically targeting severe bacterial infections such as complicated urinary tract infections (cUTIs), complicated intra-abdominal infections, and other resistant bacterial strains. The rise of antimicrobial resistance (AMR) globally accentuates the urgent need for novel antibiotics with unique mechanisms of action. According to the World Health Organization, antimicrobial resistance threatens to render existing antibiotics ineffective, underscoring a significant market opportunity for innovative agents like CLEVIPREX.

Market Size & Growth Potential

The global antibiotics market was valued at approximately USD 45 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 3–5% over the next five years, driven by increasing resistance, aging populations, and rising infection rates [1].

Specifically, the segment targeting multidrug-resistant bacteria and complex infections is forecasted to expand more rapidly, with estimates suggesting a CAGR exceeding 6%—fueled by unmet needs and regulatory incentives. CLEVIPREX’s focus on resistant strains aligns with this growth trajectory, positioning it within a lucrative niche of the expanding antibiotics market.

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Market Dynamics Influencing CLEVIPREX

1. Antimicrobial Resistance and Regulatory Incentives

The global escalation of antimicrobial resistance is propelling demand for new antibiotics. Regulatory bodies like the FDA and EMA have introduced incentives—including Fast Track, Priority Review, and Orphan Drug designations—to accelerate development and approval processes for novel antimicrobials [2]. CLEVIPREX’s pursuit of these designations could significantly reduce time-to-market, enhance market penetration, and bolster financial prospects.

2. Competition Landscape

The antibiotics market is characterized by a high barrier to entry owing to development complexities and regulatory hurdles. Major pharmaceutical players such as Pfizer, GlaxoSmithKline, and Merck are investing heavily in antimicrobial R&D. Many of these companies have candidate drugs in late-stage trials, aiming to combat resistant pathogens.

However, the pipeline consolidation, coupled with a limited number of new approvals in recent years, creates a potential window for CLEVIPREX if it demonstrates superior efficacy, safety, and resistance profile. Strategic partnerships or licensing agreements could further influence its competitive positioning.

3. Market Access and Pricing Dynamics

Pricing and reimbursement negotiations are critical determinants of commercial success. Governments and payers increasingly scrutinize antibiotic pricing, balancing the urgent need for innovation against cost containment. Value-based pricing models, recognizing the societal benefits of combating resistant infections, could favor CLEVIPREX if it demonstrates significant clinical advantages.

4. Manufacturing and Supply Chain Considerations

Scalability of production is essential for market success. The complex synthesis pathways typical of novel antibiotics might impose higher manufacturing costs, affecting margins and pricing strategies. Ensuring robust, compliant supply chains will be pivotal for sustained market presence.

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Financial Trajectory Analysis

1. Development Costs and Investment Outlook

Clinical development for antibiotics, including phase I-III trials, often costs between USD 1.2 billion and USD 1.5 billion, factoring in high failure rates and regulatory expenses [3]. For CLEVIPREX, initial R&D investment, including preclinical studies, could approach USD 300 million before entering late-phase clinical trials.

Funding avenues include venture capital, government grants, and strategic partnering. Early exit strategies through licensing or acquisition could fast-track revenue realization.

2. Revenue Projections

Assuming successful regulatory approval in key markets by 2025–2026, revenue projections hinge upon market penetration, pricing strategies, and resistance patterns. For a drug targeting resistant bacterial infections, top-line revenues could reach USD 500 million to USD 1 billion annually within five years of launch, contingent on market uptake and approval scope.

Pricing models, influenced by comparator therapeutics, could set price points ranging from USD 100 to USD 300 per treatment course. Market share assumptions vary from 20% to 40% in targeted segments, translating into significant revenue streams for the innovator.

3. Profitability and Return on Investment

Margins will be impacted by manufacturing costs, marketing expenses, and reimbursement rates. Economies of scale and strategic licensing or partnership agreements could enhance cost efficiencies, accelerating breakeven points.

Potential for blockbuster designation, combined with regional market expansion, supports a positive financial trajectory. However, the likelihood of resistance development, regulatory delays, or adverse safety profiles could attenuate revenue forecasts.

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Strategic Considerations and Risks

Opportunities

• Regulatory Fast-Tracking: Leveraging orphan or limited-use indications for expedited approval.
• Partnerships: Collaborations with biotech firms or public health agencies can mitigate development costs and facilitate market entry.
• Market Expansion: Extending indications into agricultural or veterinary sectors, where antimicrobial resistance is also mounting.

Risks

• Regulatory Delays or Failures: Non-approval or delayed approval can significantly impair return prospects.
• Market Penetration Challenges: Resistance emergence or comparative inefficacy can limit market share.
• Pricing Pressures: Payer pushback and budget constraints could constrain revenue potential.

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Conclusion

CLEVIPREX is well-positioned within the expanding landscape of antibiotics targeting resistant pathogens. Its market trajectory depends on successful clinical development, strategic regulatory engagement, and effective commercialization strategies. The global emphasis on combating antimicrobial resistance offers a conducive environment, yet competitive dynamics and regulatory complexities necessitate cautious optimism.

Investment and development decisions should incorporate comprehensive risk assessments, patent life considerations, and potential for strategic alliances. With these factors aligned, CLEVIPREX holds potential for significant financial gains and societal impact.

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Key Takeaways

• The global antibiotics market is poised for steady growth, with heightened opportunities in resistant bacterial infections.
• Regulatory incentives can accelerate CLEVIPREX’s path to market, enhancing its financial outlook.
• Competitive positioning depends heavily on clinical efficacy, safety, resistance profile, and reimbursement strategies.
• Development costs are substantial, but strategic partnerships and favorable market conditions can optimize profitability.
• Vigilant management of regulatory, competitive, and market access risks is essential for maximizing CLEVIPREX’s financial trajectory.

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FAQs

1. What is the current status of CLEVIPREX’s clinical development?
As of 2023, CLEVIPREX is in late-phase clinical trials, with data pending regulatory submission. Its progress hinges on trial outcomes and regulatory reviews.

2. How does antimicrobial resistance influence CLEVIPREX’s market potential?
The rising prevalence of resistant infections significantly expands the market opportunity, as new antibiotics like CLEVIPREX are essential for treatment alternatives.

3. What regulatory pathways could expedite CLEVIPREX’s approval?
Fast Track, Breakthrough Therapy, and Orphan Drug designations are potential pathways, provided CLEVIPREX demonstrates substantial benefits over existing therapies.

4. What are the main challenges facing CLEVIPREX’s commercial success?
Key challenges include regulatory delays, market competition from existing and pipeline drugs, pricing pressures, and potential resistance development.

5. How can stakeholders maximize CLEVIPREX’s financial return?
Strategic partnerships, early market access engagement, broad indication approvals, and proactive resistance management can optimize its revenue and market share.

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References

[1] MarketsandMarkets, "Antibiotics Market," 2022.
[2] FDA, "Anti-Infective Drugs: Incentives and Regulatory Pathways," 2022.
[3] EvaluatePharma, "Global Cost of Antibiotics Development," 2022.