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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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: | 799 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CLEVIPREX
*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 |
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of CLEVIPREX is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting CLEVIPREX
Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | 022156-001 | Aug 1, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Brazil
Patent: 2013008601
Patent: formulações de emulsão de clevidipina contendo agentes antimicrobianos
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 14495
Patent: PREPARATIONS DE CLEVIDIPINE EN EMULSION CONTENANT DES AGENTS ANTIMICROBIENS (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 3237446
Patent: Clevidipine emulsion formulations containing antimicrobial agents
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 27173
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2849
Patent: ЭМУЛЬСИОННЫЕ КОМПОЗИЦИИ КЛЕВИДИПИНА, СОДЕРЖАЩИЕ ПРОТИВОМИКРОБНЫЕ АГЕНТЫ (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷ Sign Up
Patent: 1390541
Patent: ЭМУЛЬСИОННЫЕ КОМПОЗИЦИИ КЛЕВИДИПИНА, СОДЕРЖАЩИЕ ПРОТИВОМИКРОБНЫЕ АГЕНТЫ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 27173
Patent: PRÉPARATIONS DE CLÉVIDIPINE EN ÉMULSION CONTENANT DES AGENTS ANTIMICROBIENS (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Hungary
Patent: 26295
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 40437
Estimated Expiration: ⤷ Sign Up
Patent: 26094
Estimated Expiration: ⤷ Sign Up
Patent: 37743
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent: 14504259
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Mexico
Patent: 6537
Patent: FORMULACIONES DE EMULSION DE CLEVIDIPINA QUE CONTIENEN AGENTES ANTIMICROBIANOS. (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS.)
Estimated Expiration: ⤷ Sign Up
Patent: 13004151
Patent: FORMULACIONES DE EMULSION DE CLEVIDIPINA QUE CONTIENEN AGENTES ANTIMICROBIANOS. (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0465
Patent: Clevidipine emulsion formulations containing antimicrobial agents
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 27173
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 27173
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1786857
Estimated Expiration: ⤷ Sign Up
Patent: 130101080
Patent: CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS
Estimated Expiration: ⤷ Sign Up
Patent: 160032266
Patent: 항미생물제를 함유하는 클레비디핀 에멀젼 제제 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 39861
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Taiwan | 279859 | ⤷ Sign Up | |
| Japan | 2014504259 | ⤷ Sign Up | |
| Sweden | 9303657 | ⤷ Sign Up | |
| Norway | 961776 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2012051116 | ⤷ Sign Up | |
| Denmark | 2627173 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CLEVIPREX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0726894 | 92209 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: CLEVIDIPINE SOUS TOUTES LES FORMES PROCURANT UNE PROTECTION A PARTIR DU BREVET DE BASE |
| 0726894 | SPC/GB12/011 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123 |
| 0726894 | C300520 | Netherlands | ⤷ Sign Up | PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: RVG 104771 20111129; FIRST REGISTRATION: PL 16881/0003 20111123 |
| 0726894 | C00726894/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: RACEMISCHES CLEVIDIPINBUTYRAT; REGISTRATION NO/DATE: SWISSMEDIC 60117 11.06.2010 |
| 0726894 | 1290008-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: CLEVIDIPINE; NAT. REG. NO/DATE: 42321 20120120; FIRST REG.: GB PL 16881/0003 20111123 |
| 0726894 | 12C0053 | France | ⤷ Sign Up | PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: GB - PL 16881/0003 20111123 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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