CLEVIPREX Drug Patent Profile
✉ Email this page to a colleague
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: | 112 |
Clinical Trials: | 14 |
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
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 |
---|---|
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | Phase 3 |
University of California, San Francisco | Early Phase 1 |
University of Zurich | 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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Clevidipine emulsion formulations containing antimicrobial agents
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>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: ⤷ Try a Trial
Brazil
Patent: 2013008601
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 14495
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3237446
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 27173
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 2849
Estimated Expiration: ⤷ Try a Trial
Patent: 1390541
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 27173
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 87495
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 26295
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 40437
Estimated Expiration: ⤷ Try a Trial
Patent: 26094
Estimated Expiration: ⤷ Try a Trial
Patent: 37743
Estimated Expiration: ⤷ Try a Trial
Patent: 14196322
Estimated Expiration: ⤷ Try a Trial
Patent: 14504259
Estimated Expiration: ⤷ Try a Trial
Patent: 16183183
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 6537
Estimated Expiration: ⤷ Try a Trial
Patent: 13004151
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0465
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 27173
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 27173
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1786857
Estimated Expiration: ⤷ Try a Trial
Patent: 130101080
Estimated Expiration: ⤷ Try a Trial
Patent: 160032266
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 39861
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Egypt | 20539 | Process for preparing of dihydraphyridines and their use as pharmaceutical compositions in lowering blood pressure | ⤷ Try a Trial |
Hungary | T74474 | ⤷ Try a Trial | |
Japan | H09504542 | ⤷ Try a Trial | |
New Zealand | 276197 | PHARMACEUTICAL EMULSION OF A 4-PHENYL SUBSTITUTED DIHYDROPYRIDINE 3,5-DICARBOXYLIC ACID ESTER DERIVATIVE | ⤷ Try a Trial |
Japan | 2014196322 | 抗菌剤を含むクレビジピン乳化製剤 (CLEVIDIPINE EMULSION FORMULATIONS CONTAINING ANTIMICROBIAL AGENTS) | ⤷ Try a Trial |
South Korea | 101786857 | ⤷ Try a Trial | |
New Zealand | 275915 | 4-PHENYL SUBSTITUTED DIHYDROPYRIDINE 3,5-DICARBOXYLIC ACID ESTER DERIVATIVES AND MEDICAMENTS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CLEVIPREX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0726894 | 1290008-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: CLEVIDIPINE; NAT. REG. NO/DATE: 42321 20120120; FIRST REG.: GB PL 16881/0003 20111123 |
0726894 | SPC/GB12/011 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123 |
0726894 | C00726894/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: RACEMISCHES CLEVIDIPINBUTYRAT; REGISTRATION NO/DATE: SWISSMEDIC 60117 11.06.2010 |
0726894 | 12C0053 | France | ⤷ Try a Trial | PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: GB - PL 16881/0003 20111123 |
0726894 | C300520 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: RVG 104771 20111129; FIRST REGISTRATION: PL 16881/0003 20111123 |
0726894 | 92209 | Luxembourg | ⤷ Try a Trial | 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 |