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:	113
Clinical Trials:	15
Patent Applications:	1,027
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

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	5,739,152
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-001	Aug 1, 2008	5,739,152
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-003	Nov 8, 2013	5,856,346
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	Aug 1, 2008	5,739,152
Chiesi	CLEVIPREX	clevidipine	EMULSION;INTRAVENOUS	022156-002	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
Poland	2627173
Japan	6437743
Slovakia	55996	SHORT-ACTING DIHYDROPYRIDINES
Japan	6326094
Japan	3712209

Supplementary Protection Certificates for CLEVIPREX

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

Market Dynamics and Financial Trajectory for Cleviprex

Overview of Cleviprex

Cleviprex, also known as clevidipine, is a late-generation dihydropyridine calcium channel antagonist used primarily for the management of acute elevation of blood pressure in perioperative settings. Its fast-acting and reliable properties make it a valuable treatment option in hospitals.

Market Size and Forecast

The global Cleviprex market is projected to experience significant growth over the forecast period. As of 2024, the market size was valued at USD 356.74 million and is expected to reach USD 496.71 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.66% during the forecast period of 2024-2031[2].

Key Drivers of Market Growth

Increasing Demand for Effective Hypertension Treatment

The rising prevalence of hypertension globally is a major driver for the Cleviprex market. As hypertension rates continue to increase, the demand for fast-acting and reliable treatment options like Cleviprex is expected to grow. Cleviprex's ability to reduce blood pressure quickly and effectively, particularly in perioperative settings, makes it an attractive option for healthcare professionals[2].

Favorable Reimbursement Policies

Favorable reimbursement policies in many countries have significantly contributed to the market adoption of Cleviprex. The coverage of Cleviprex by healthcare systems and insurance providers makes it an accessible treatment option for patients who need it, thereby boosting its market growth[2].

Advantages Over Other Medications

Cleviprex does not rely on the kidneys for metabolism, which is a significant advantage, especially for patients with impaired kidney function. This characteristic, combined with its fast-acting nature and suitability for intravenous administration, enhances its market appeal[2].

Market Segmentation

By Type

The Cleviprex market is segmented based on the purity of the drug, with categories including Purity >98% and Purity <98%. The Purity <98% segment is expected to grow considerably due to the high demand for high-quality medicines that meet strict purity standards[2].

By Application

The market is segmented into pharmaceutical intermediates, chemical intermediates, and other applications. The pharmaceutical intermediates segment dominated the market in 2021, driven by the increasing development by key players and rising government initiatives in the pharmaceutical industry[2].

By Geography

Geographically, the Cleviprex market is classified into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. North America dominated the market in 2021 and is expected to maintain its position due to the presence of several key market players and advanced pharmaceutical infrastructure in the region[2].

Financial Performance and Key Players

Market Value and Growth

The financial trajectory of Cleviprex is marked by steady growth, with the market expected to reach USD 496.71 million by 2031. This growth is driven by increasing demand and favorable market conditions[2].

Key Players

Chiesi Farmaceutici is one of the main players in the Cleviprex market. Other notable companies include AdooQ BioScience, Boc Sciences, AK Scientific, Nova Chemistry, and Toronto Research Chemicals. These companies are involved in various activities such as product launches, mergers and acquisitions, business expansions, and partnerships that contribute to the market's growth[2][4].

Regulatory and Pricing Dynamics

Voluntary Compliance Undertakings (VCUs)

In Canada, Chiesi USA, Inc. agreed to offset excess revenues generated by Cleviprex and reduce its price to comply with the Patented Medicine Prices Review Board (PMPRB) guidelines. This agreement ensures that the price of Cleviprex remains within the PMPRB’s guidelines in future periods[3].

Clinical Efficacy and Safety

Clinical Studies

Cleviprex has been evaluated in several clinical studies, including ESCAPE-1, ESCAPE-2, VELOCITY, and ACCELERATE. These studies have demonstrated its efficacy in reducing blood pressure quickly and effectively in various clinical settings. For example, in the ESCAPE-1 study, 92.5% of patients on Cleviprex achieved treatment success, defined as a reduction of systolic blood pressure by ≥15% from baseline within 30 minutes[5].

Safety Profile

While Cleviprex is generally well-tolerated, it can have side effects such as headache, nausea, chest discomfort, and vomiting. Serious adverse events are relatively rare, with an incidence of 8.7% in the safety population of one study[5].

Challenges and Restraints

Side Effects and Adverse Events

Despite its benefits, Cleviprex can cause side effects such as atrial fibrillation, acute renal failure, and nausea, particularly in the perioperative context. These side effects can hinder market growth. Additionally, cardiac arrest, myocardial infarction, syncope, and dyspnea are possible side effects in individuals with severe or essential hypertension[2].

Key Takeaways

• Market Growth: The Cleviprex market is projected to grow at a CAGR of 4.66% from 2024 to 2031.
• Key Drivers: Increasing demand for effective hypertension treatment, favorable reimbursement policies, and advantages over other medications.
• Market Segmentation: Segmented by type, application, and geography, with North America dominating the market.
• Financial Performance: Steady growth driven by increasing demand and favorable market conditions.
• Regulatory Dynamics: Compliance with pricing guidelines through VCUs in regions like Canada.
• Clinical Efficacy: Proven efficacy in clinical studies with a strong safety profile.

FAQs

Q: What is the primary use of Cleviprex?

A: Cleviprex is primarily used for the management of acute elevation of blood pressure in perioperative settings.

Q: What is the projected market size of Cleviprex by 2031?

A: The Cleviprex market is projected to reach USD 496.71 million by 2031[2].

Q: Which region dominates the Cleviprex market?

A: North America dominates the Cleviprex market due to the presence of several key market players and advanced pharmaceutical infrastructure[2].

Q: What are the common side effects of Cleviprex?

A: Common side effects include headache, nausea, chest discomfort, and vomiting. Serious adverse events are relatively rare[5].

Q: How does Cleviprex compare to other hypertension medications?

A: Cleviprex does not rely on the kidneys for metabolism, making it a valuable option for patients with impaired kidney function. It also has a fast-acting nature and is suitable for intravenous administration[2].

Sources

1. Market Research Intellect - Clevidipine Market Size, Share, Outlook, Analysis and Forecast[1].
2. Verified Market Research - Cleviprex Market Size, Share, Scope, Trends, Analysis & Forecast[2].
3. Canada.ca - PMPRB NEWSletter: June 2023, Volume 27, Issue 1[3].
4. Valuates Reports - Global Clevidipine Market Research Report 2024[4].
5. Cleviprex.com - Efficacy | CLEVIPREX® (clevidipine)[5].

Last updated: 2024-12-16