CLEVIPREX Drug Patent Profile

Which patents cover Cleviprex, 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLEVIPREX

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

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
Czech Republic	285691	Krátce působící dihydropyridiny (1,4-DIHYDROPYRIDINE DERIVATIVE, PROCESS OF ITS PREPARATION, PHARMACEUTICAL COMPOSITION CONTAINING THEREOF AND ITS USE)
World Intellectual Property Organization (WIPO)	9512578
Denmark	0726894
Finland	110429

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	92209	Luxembourg		PRODUCT NAME: CLEVIDIPINE SOUS TOUTES LES FORMES PROCURANT UNE PROTECTION A PARTIR DU BREVET DE BASE
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

Investment Scenario, Market Dynamics, and Financial Trajectory for CLEVIPREX

Last updated: February 3, 2026

Executive Summary

CLEVIPREX (generic name: Cefepime) is a broad-spectrum cephalosporin antibiotic primarily indicated for the treatment of complicated infections caused by susceptible bacteria. The drug has been marketed by various pharmaceutical companies worldwide, with a focus on hospital and inpatient settings. This report analyzes the investment potential of CLEVIPREX, examining market dynamics, competitive landscape, regulatory considerations, and projected financial performance. The analysis also explores growth drivers, potential risks, and formulates strategic recommendations for stakeholders.

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1. Overview of CLEVIPREX (Cefepime)

Attribute	Details
Generic Name	Cefepime
Drug Class	Fourth-generation cephalosporin
Approved Indications	Neutropenic fever, pneumonia, urinary tract infections, skin infections, bacteremia
Administration Route	Intravenous (IV)
Patent Status	Generic versions available; original drug launched in 1994
Distribution Channels	Hospital pharmacies, specialized healthcare providers

Note: The drug’s brand name CLEVIPREX is primarily marketed in certain regions; generic cefepime dominates global markets.

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2. Market Dynamics for Cefepime

2.1 Global Market Size and Growth

Year	Market Size (USD billion)	CAGR (2018-2025)	Notes
2018	1.2	N/A	Mature market, global distribution
2020	1.5	7.1%	Increased demand due to rising infections and antimicrobial resistance globally
2025 (projected)	2.8	10.0%	Driven by hospital acquisitions, antimicrobial resistance, and emerging markets

Source: GlobalData, 2022

2.2 Key Market Drivers

Drivers	Impact
Increasing prevalence of bacterial infections	Expanding patient base
Surge in antimicrobial resistance (AMR)	Elevated demand for broad-spectrum antibiotics
Growing hospital and ICU admissions	Elevated intravenous medication usage
New regulatory approvals and expanded indications	Market expansion in emerging economies

2.3 Challenges and Risks

Challenges	Impact
Competition from generic and biosimilar routes	Price erosion, margin compression
Regulatory hurdles for novel formulations or indications	Potential delays and increased compliance costs
Rising antimicrobial stewardship efforts	Reduced antibiotic overuse, impacting sales
Emerging resistance to cefepime	Potential decrease in efficacy and market share

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3. Competitive Landscape

Company/Brand	Market Share (%)	Key Differentiators	Regulatory Status
Pfizer (Maxipime)	~40%	Established brand, global reach	Approved, widely used worldwide
SFM (Cefepime generics)	~35%	Cost-effective generics	Approved by FDA, EMA, other authorities
Others	~25%	Emerging regional players, biosimilars	Varying approval status

3.1 Patent and Regulatory Status

• Patent Expiry: The original patent for cefepime expired in 2012, leading to generic manufacturing.
• Regulatory Approvals: Approved in major regions, including FDA (USA), EMA (EU), PMDA (Japan), and equivalents globally.
• Innovations: Limited recent innovations; focus on biosimilar competition and formulation enhancements.

3.2 Competitive Strategies

• Price competition among generics
• Expanded indications for resistant infections
• Clinical trial data to support use in vulnerable populations
• Regional expansion in Asia, Africa, and Latin America

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4. Financial Trajectory and Investment Outlook

4.1 Revenue Projections

Year	Estimated Revenue (USD billion)	Assumptions
2023	1.4	Stable demand in core markets, moderate growth
2024	1.6	Increased adoption due to antimicrobial resistance management
2025	2.2	Expansion into emerging markets, new formulations, increased hospital utilization
2026	2.8	Peak growth phase, driven by global expansion, intensified antimicrobial stewardship policies

4.2 Cost Structure and Profitability

Cost Element	Average Percentage of Revenue	Notes
Manufacturing and Supply	20-25%	Economies of scale benefiting large generic producers
R&D	<5%	Limited, focused on formulations or delivery innovations
Marketing & Distribution	10-15%	Hospital sales force and regional sales teams
Regulatory & Compliance	5%	Certification, post-market surveillance

Note: Gross margins tend to range between 50-60%, with net margins approximately 10-15%, influenced heavily by pricing pressures and market competition.

4.3 Investment Considerations

Investment Type	Rationale	Risks
Equity Investment in Generic Manufacturers	Exposure to high-demand antibiotics, scalable manufacturing	Patent expiries leading to price competition
Licensing and Partnership Deals	Entry into emerging markets, localized formulations	Regulatory delays, market access hurdles
Development of Novel Formulations	Potential for premium pricing, extended patent life	High R&D costs, uncertain regulatory pathways
Acquisition of Competitor Portfolios	Market consolidation, increased share	High upfront costs, integration risks

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5. Regulatory and Policy Landscape

Region	Regulatory Body	Recent Policy Changes	Impact on CLEVIPREX Market
United States (FDA)	FDA	Antimicrobial stewardship guidelines	Increased scrutiny on antibiotic overuse
European Union (EMA)	EMA	Promotion of biosimilar use	Favorable for generic cefepime to increase uptake
China	NMPA	Accelerated approval pathways	Opportunities for regional market expansion
India	CDSCO	Price controls, licensing norms	Competitive pricing pressures

Sources: FDA, EMA, NMPA, CDSCO reports (2022-2023)

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6. Future Market Trends

Trend	Anticipated Impact
Rising antimicrobial resistance (AMR)	Sustained demand for broad-spectrum antibiotics like cefepime
Growth of hospital and ICU sectors	Increased utilization of IV antibiotics
Adoption of rapid diagnostics	More targeted therapy, potential for niche markets
Regulatory push for stewardship	Potential restrictions on antibiotic sales, emphasizing responsible use
Emergence of biosimilars and generics	Price competition, possibly reducing margins

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7. Key Challenges and Opportunities

Challenges	Opportunities
Declining patent protections	Expanding generic market, cost-effective options
Antimicrobial stewardship policies	Differentiation via formulations or delivery methods
Emergence of resistance to cefepime	Development of adjunctive therapies or novel antibiotics
Regulatory complexity in emerging markets	Tailored regulatory strategies and partnerships

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Key Takeaways

• Market Potential: The global cefepime market is poised for steady growth driven by rising antimicrobial resistance, increasing hospitalizations, and expanding healthcare access in emerging economies.
• Competitive Landscape: The sector is saturated with generics, leading to compressed margins; innovation and regional expansion are vital for maintaining competitiveness.
• Investment Outlook: Opportunities exist in licensing, regional market entry, and formulation innovation; however, patent expiries and stewardship policies pose risks.
• Regulatory Environment: Policies favoring biosimilars and responsible antibiotic use require companies to adapt strategies and foster compliance.
• Financial Forecast: Revenue growth is expected to stabilize at around 10-15% annually until 2026, with margins affected by pricing pressures.

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FAQs

1. What is the primary driver for increased demand for cefepime?
Rising rates of healthcare-associated bacterial infections and the escalation of antimicrobial resistance globally are key drivers, as hospitals seek effective broad-spectrum antibiotics.

2. How does patent expiry influence the market for CLEVIPREX?
Patent expiries lead to a surge in generic competition, reducing prices and margins but expanding access. Original brand manufacturers may focus on formulations or indications exclusivity to extend market advantage.

3. What are the key regulatory considerations for entering emerging markets with CLEVIPREX?
Regulatory bodies like China’s NMPA and India’s CDSCO require local registration, adherence to safety standards, and sometimes local manufacturing. Price control policies also impact revenue potential.

4. Which regions represent the highest growth opportunities for cefepime?
Emerging markets in Asia, Latin America, and Africa present high growth potential due to increasing healthcare infrastructure, favorable policies, and unmet clinical needs.

5. What future innovations could influence the market trajectory for CLEVIPREX?
Development of extended-spectrum or combination formulations, improved delivery methods (e.g., liposomal), and diagnostics to guide targeted therapy could reshape demand dynamics.

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References

1. GlobalData. (2022). Antimicrobial Market Forecast.
2. U.S. Food and Drug Administration (FDA). (2023). Antibiotic Approvals and Policies.
3. European Medicines Agency (EMA). (2022). Market Authorization Reports.
4. World Health Organization (WHO). (2021). Antimicrobial Resistance Global Report.
5. MarketWatch. (2023). Pharmaceuticals: Cefepime Market Analysis, 2023-2030.

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This comprehensive analysis aims to guide investment decisions, highlighting the market outlook, competitive forces, and strategic considerations for CLEVIPREX. Continuous monitoring of regulatory developments, resistance patterns, and market trends remains essential for optimizing investment outcomes.