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Last Updated: December 23, 2024

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CLEVIPREX Drug Patent Profile


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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

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CLEVIPREX
Generic Entry Date for CLEVIPREX*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University of California, San DiegoPhase 4
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Phase 3
University of California, San FranciscoEarly Phase 1

See all CLEVIPREX clinical trials

Pharmacology 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CLEVIPREX is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CLEVIPREX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008 ⤷  Subscribe ⤷  Subscribe
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-001 Aug 1, 2008 ⤷  Subscribe ⤷  Subscribe
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013 ⤷  Subscribe ⤷  Subscribe
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-002 Aug 1, 2008 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Patent: 11313852
Patent: Clevidipine emulsion formulations containing antimicrobial agents
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2013008601
Patent: formulações de emulsão de clevidipina contendo agentes antimicrobianos
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 14495
Patent: PREPARATIONS DE CLEVIDIPINE EN EMULSION CONTENANT DES AGENTS ANTIMICROBIENS (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Subscribe

China

Patent: 3237446
Patent: Clevidipine emulsion formulations containing antimicrobial agents
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 27173
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 2849
Patent: ЭМУЛЬСИОННЫЕ КОМПОЗИЦИИ КЛЕВИДИПИНА, СОДЕРЖАЩИЕ ПРОТИВОМИКРОБНЫЕ АГЕНТЫ (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Subscribe

Patent: 1390541
Patent: ЭМУЛЬСИОННЫЕ КОМПОЗИЦИИ КЛЕВИДИПИНА, СОДЕРЖАЩИЕ ПРОТИВОМИКРОБНЫЕ АГЕНТЫ
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 27173
Patent: PRÉPARATIONS DE CLÉVIDIPINE EN ÉMULSION CONTENANT DES AGENTS ANTIMICROBIENS (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 87495
Patent: 含有抗微生物劑的氯維地平乳劑製劑 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 26295
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 40437
Estimated Expiration: ⤷  Subscribe

Patent: 26094
Estimated Expiration: ⤷  Subscribe

Patent: 37743
Estimated Expiration: ⤷  Subscribe

Patent: 14196322
Patent: 抗菌剤を含むクレビジピン乳化製剤 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Subscribe

Patent: 14504259
Estimated Expiration: ⤷  Subscribe

Patent: 16183183
Patent: 抗菌剤を含むクレビジピン乳化製剤 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 6537
Patent: FORMULACIONES DE EMULSION DE CLEVIDIPINA QUE CONTIENEN AGENTES ANTIMICROBIANOS. (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS.)
Estimated Expiration: ⤷  Subscribe

Patent: 13004151
Patent: FORMULACIONES DE EMULSION DE CLEVIDIPINA QUE CONTIENEN AGENTES ANTIMICROBIANOS. (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS.)
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 0465
Patent: Clevidipine emulsion formulations containing antimicrobial agents
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 27173
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 27173
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1786857
Estimated Expiration: ⤷  Subscribe

Patent: 130101080
Patent: CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS
Estimated Expiration: ⤷  Subscribe

Patent: 160032266
Patent: 항미생물제를 함유하는 클레비디핀 에멀젼 제제 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 39861
Estimated Expiration: ⤷  Subscribe

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 290772 Farmaceutický přípravek (Pharmaceutical preparation) ⤷  Subscribe
Spain 2172572 ⤷  Subscribe
European Patent Office 0726894 DIHYDROPYRIDINES A ACTIVITE COURTE (SHORT-ACTING DIHYDROPYRIDINES) ⤷  Subscribe
Japan 3759951 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CLEVIPREX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0726894 SPC/GB12/011 United Kingdom ⤷  Subscribe PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123
0726894 1290008-0 Sweden ⤷  Subscribe PRODUCT NAME: CLEVIDIPINE; NAT. REG. NO/DATE: 42321 20120120; FIRST REG.: GB PL 16881/0003 20111123
0726894 C00726894/01 Switzerland ⤷  Subscribe PRODUCT NAME: RACEMISCHES CLEVIDIPINBUTYRAT; REGISTRATION NO/DATE: SWISSMEDIC 60117 11.06.2010
0726894 C300520 Netherlands ⤷  Subscribe PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: RVG 104771 20111129; FIRST REGISTRATION: PL 16881/0003 20111123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

CLEVIPREX Market Analysis and Financial Projection Experimental

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].

More… ↓

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