CLEVIDIPINE - Generic Drug Details

What are the generic drug sources for clevidipine and what is the scope of patent protection?

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.

There are three drug master file entries for clevidipine. Two suppliers are listed for this compound.

Summary for CLEVIDIPINE

International Patents:	26
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	27
Patent Applications:	1,263
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLEVIDIPINE
What excipients (inactive ingredients) are in CLEVIDIPINE?	CLEVIDIPINE excipients list
DailyMed Link:	CLEVIDIPINE at DailyMed

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

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 CLEVIDIPINE

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
ProMedica Health System	Phase 3

See all CLEVIDIPINE clinical trials

Pharmacology for CLEVIDIPINE

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

Anatomical Therapeutic Chemical (ATC) Classes for CLEVIDIPINE

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

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	022156-002	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	022156-003	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	022156-001	Aug 1, 2008		RX	Yes	Yes			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
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	022156-003	Nov 8, 2013

International Patents for CLEVIDIPINE

Country	Patent Number	Title	Estimated Expiration
Japan	2014504259
Poland	2627173
Eurasian Patent Organization	201390541	ЭМУЛЬСИОННЫЕ КОМПОЗИЦИИ КЛЕВИДИПИНА, СОДЕРЖАЩИЕ ПРОТИВОМИКРОБНЫЕ АГЕНТЫ
South Korea	101786857
Japan	2014196322	抗菌剤を含むクレビジピン乳化製剤 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)

Supplementary Protection Certificates for CLEVIDIPINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C300520	Netherlands		PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: RVG 104771 20111129; FIRST REGISTRATION: PL 16881/0003 20111123
0726894	12C0053	France		PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: GB - PL 16881/0003 20111123
0726894	SPC/GB12/011	United Kingdom		PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123

CLEVIDIPINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clevidipine

Introduction

Clevidipine, a small molecule drug targeting the L-type calcium channel, has been a significant player in the management of cardiovascular diseases, particularly in the treatment of perioperative hypertension, hypertension, and hypotension. Here, we delve into the market dynamics and financial trajectory of clevidipine, exploring its approval history, mechanism of action, clinical efficacy, cost implications, and market share.

Approval History and Regulatory Acceptance

Clevidipine received its first approval in the United States in August 2008, marking its entry into the market over a decade ago. This approval by regulatory authorities highlights its recognition and acceptance as a viable treatment option for cardiovascular conditions[1].

Mechanism of Action

Clevidipine works by interacting with the L-type calcium channel, which is crucial for regulating calcium ions in smooth muscle cells. By blocking this channel, clevidipine helps to relax and dilate blood vessels, leading to a reduction in blood pressure. This mechanism makes it particularly effective for managing hypertension and hypotension during surgical procedures[1].

Clinical Efficacy

Clinical trials, such as the ECLIPSE trials, have demonstrated the efficacy of clevidipine in managing blood pressure. These trials showed that clevidipine resulted in a shorter time to extubation and a shorter intensive care unit (ICU) stay compared to other intravenous antihypertensives like nitroglycerin, sodium nitroprusside, and nicardipine. This reduced the overall costs associated with ICU stay and extubation time[2].

Cost Implications

Despite its clinical benefits, clevidipine is significantly more expensive than other intravenous antihypertensives. Cost analyses have indicated that while clevidipine may offer cost savings in terms of reduced ICU stay and time to extubation, its acquisition cost is higher. For instance, the acquisition price per milliliter of clevidipine is $1.46, compared to $0.19 for nicardipine and $0.06 for labetalol[3][5].

Cost Savings and Resource Utilization

Studies have shown that the use of clevidipine can lead to cost savings through reduced resource utilization. For example, the ECLIPSE trials found median cost savings of $887 for ICU stay and $34 for time to extubation when using clevidipine compared to pooled comparators. However, these savings are offset by the higher acquisition cost of the drug[2].

Economic Impact in Different Settings

In neurological emergencies and acute hypertension, the economic impact of clevidipine has been evaluated. These analyses suggest that while clevidipine may offer benefits in terms of rapid blood pressure control, its overall economic impact is influenced by its higher cost. The projected market share of clevidipine is increasing, but it still lags behind other antihypertensives like nicardipine in terms of market share[3][5].

Market Share and Competitive Landscape

The market for L-type calcium channel blockers is competitive, with multiple companies involved in research and development. Clevidipine, although gaining traction, still holds a relatively small market share compared to other drugs like nicardipine and labetalol. However, its market share is projected to increase, reaching 39% by the third year in some forecasts[3][5].

Global Development

Japan, China, and the United States are leading countries in the development of drugs targeting the L-type calcium channel. China, in particular, has seen significant progress with several drugs in the approved phase. This global activity indicates a dynamic and evolving market landscape[1].

Financial Trajectory

The financial trajectory of clevidipine is marked by its increasing adoption and market share, despite its higher cost. Here are some key financial aspects:

Acquisition Costs

Clevidipine's higher acquisition cost is a significant factor in its financial trajectory. The cost per milliliter is substantially higher than that of its competitors, which can impact its overall economic viability[3][5].

Cost-Benefit Analysis

While clevidipine offers cost savings in certain areas such as reduced ICU stay and time to extubation, these benefits must be weighed against its higher acquisition cost. This balance is crucial in determining its financial feasibility in different clinical settings[2][4].

Market Growth

The projected increase in clevidipine's market share suggests a positive financial trajectory. As more hospitals and healthcare providers adopt clevidipine for its clinical benefits, its revenue is likely to grow, despite the initial higher costs[3][5].

Conclusion

Clevidipine's market dynamics and financial trajectory are complex, influenced by its clinical efficacy, cost implications, and competitive landscape. While it offers significant clinical benefits and is gaining market share, its higher acquisition cost remains a critical factor in its financial viability.

Key Takeaways

• Approval and Acceptance: Clevidipine was approved in the US in 2008 and is recognized for treating perioperative hypertension, hypertension, and hypotension.
• Mechanism of Action: It targets the L-type calcium channel, relaxing and dilating blood vessels to reduce blood pressure.
• Clinical Efficacy: It reduces ICU stay and time to extubation compared to other antihypertensives.
• Cost Implications: Higher acquisition cost but potential cost savings in resource utilization.
• Market Share: Increasing market share, but still lower than competitors like nicardipine.
• Financial Trajectory: Balanced by higher costs and potential cost savings, with projected market growth.

FAQs

What is the primary mechanism of action of clevidipine?

Clevidipine works by blocking the L-type calcium channel, which helps to relax and dilate blood vessels, reducing blood pressure.

When was clevidipine first approved in the United States?

Clevidipine was first approved in the United States in August 2008.

How does clevidipine compare to other intravenous antihypertensives in terms of cost?

Clevidipine is significantly more expensive than other intravenous antihypertensives like nicardipine and labetalol, but it may offer cost savings through reduced ICU stay and time to extubation.

What are the projected market share trends for clevidipine?

Clevidipine's market share is projected to increase, reaching up to 39% in some forecasts, although it still lags behind other antihypertensives.

Which countries are leading in the development of L-type calcium channel blockers?

Japan, China, and the United States are the leading countries in the development of drugs targeting the L-type calcium channel.

Sources

1. Patsnap Synapse: Clevidipine's R&D Progress and its Mechanism of Action on Drug ...
2. PubMed: A cost analysis of the impact of a new intravenous antihypertensive ...
3. ISPOR: Cost Consequences Analysis of Using Clevidipine in Neurological ...
4. Critical Care Medicine: Clinical evaluation and economic impact of clevidipine at a regional...
5. ISPOR: Cost Consequences Analysis of Using Clevidipine in Acute ...