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
Summary for CLEVIPREX
International Patents: | 26 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 13 |
Patent Applications: | 740 |
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 Generic Entry Opportunity 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
Sponsor | Phase |
---|---|
University of California, San Francisco | Early Phase 1 |
University of Zurich | Phase 4 |
Chiesi Farmaceutici S.p.A. | Phase 4 |
Pharmacology for CLEVIPREX
Drug Class | Dihydropyridine Calcium Channel Blocker |
Mechanism of Action | Calcium Channel Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes 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 See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | See Plans and Pricing | See Plans and Pricing |
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | See Plans and Pricing | See Plans and Pricing |
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | See Plans and Pricing | See Plans and Pricing |
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | See Plans and Pricing | See Plans and Pricing |
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | See Plans and Pricing | See Plans and Pricing |
>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
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2013008601
Estimated Expiration: See Plans and Pricing
Canada
Patent: 14495
Estimated Expiration: See Plans and Pricing
China
Patent: 3237446
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 27173
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 2849
Estimated Expiration: See Plans and Pricing
Patent: 1390541
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 27173
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 87495
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 26295
Estimated Expiration: See Plans and Pricing
Japan
Patent: 40437
Estimated Expiration: See Plans and Pricing
Patent: 26094
Estimated Expiration: See Plans and Pricing
Patent: 37743
Estimated Expiration: See Plans and Pricing
Patent: 14196322
Estimated Expiration: See Plans and Pricing
Patent: 14504259
Estimated Expiration: See Plans and Pricing
Patent: 16183183
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 6537
Estimated Expiration: See Plans and Pricing
Patent: 13004151
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 0465
Estimated Expiration: See Plans and Pricing
Poland
Patent: 27173
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 27173
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1786857
Estimated Expiration: See Plans and Pricing
Patent: 130101080
Estimated Expiration: See Plans and Pricing
Patent: 160032266
Estimated Expiration: See Plans and Pricing
Spain
Patent: 39861
Estimated Expiration: See Plans and Pricing
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) | See Plans and Pricing |
Israel | 111345 | See Plans and Pricing | |
Poland | 181462 | See Plans and Pricing | |
Eurasian Patent Organization | 022849 | ЭМУЛЬСИОННЫЕ КОМПОЗИЦИИ КЛЕВИДИПИНА, СОДЕРЖАЩИЕ ПРОТИВОМИКРОБНЫЕ АГЕНТЫ (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS) | See Plans and Pricing |
Japan | 3759951 | See Plans and Pricing | |
China | 1072934 | See Plans and Pricing | |
Portugal | 2627173 | See Plans and Pricing | |
>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 | See Plans and Pricing | PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123 |
0726894 | 1290008-0 | Sweden | See Plans and Pricing | PRODUCT NAME: CLEVIDIPINE; NAT. REG. NO/DATE: 42321 20120120; FIRST REG.: GB PL 16881/0003 20111123 |
0726894 | 12C0053 | France | See Plans and Pricing | PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: GB - PL 16881/0003 20111123 |
0726894 | C00726894/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: RACEMISCHES CLEVIDIPINBUTYRAT; REGISTRATION NO/DATE: SWISSMEDIC 60117 11.06.2010 |
0726894 | C300520 | Netherlands | See Plans and Pricing | PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: RVG 104771 20111129; FIRST REGISTRATION: PL 16881/0003 20111123 |
0726894 | 92209 | Luxembourg | See Plans and Pricing | PRODUCT NAME: CLEVIDIPINE SOUS TOUTES LES FORMES PROCURANT UNE PROTECTION A PARTIR DU BREVET DE BASE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |