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CLEVIPREX Drug Profile
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When do Cleviprex patents expire, and what generic alternatives are available?
Cleviprex is a drug marketed by Chiesi Usa Inc and is included in one NDA. There are three patents protecting this drug.
This drug has sixty-seven patent family members in thirty-three 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.
US ANDA Litigation and Generic Entry Outlook for Cleviprex
Cleviprex was eligible for patent challenges on August 1st, 2012.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 10th, 2031. This may change due to patent challenges or generic licensing.
There has been one patent litigation case 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.
Summary for CLEVIPREX
| International Patents: | 67 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 12 |
| Patent Applications: | 579 |
| Drug Prices: | Drug price information for CLEVIPREX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CLEVIPREX |
| DailyMed Link: | CLEVIPREX at DailyMed |
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 |
| Duke University | N/A |
Recent Litigation for CLEVIPREX
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| CHIESI USA, INC. v. AUROBINDO PHARMA USA, INC. | 2019-10-07 |
Pharmacology for CLEVIPREX
| Drug Class | Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
Synonyms for CLEVIPREX
| (Butanoyloxy)methyl methyl (4RS)-4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate |
| 166432-28-6 |
| 167221-71-8 |
| 221C718 |
| 3-((butyryloxy)methyl) 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarb |
| 3-((butyryloxy)methyl) 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate |
| 3-[(Butyryloxy)methyl] 5-Methyl 4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate |
| 3,5-Pyridinedicarboxylic acid, 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-, methyl (1-oxobutoxy)methyl ester |
| 4-(2,3-Dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic Acid 3-Methyl 5-[(1-Oxobutoxy)methyl] Ester |
| 4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic Aicd 3-[(Butyryloxy)methyl] 5-Methyl Ester |
| 5-O-(butanoyloxymethyl) 3-O-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate |
| AB01566888_01 |
| AB2000484 |
| ABP001090 |
| AC-24370 |
| AC1L4BI0 |
| AKOS015896325 |
| AMX10159 |
| AN-16754 |
| AS-19935 |
| BCP22687 |
| BDBM50088387 |
| Butyroxymethyl methyl 4-(2',3'-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylat |
| butyroxymethyl methyl 4-(2',3'-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate |
| C21H23Cl2NO6 |
| C3503 |
| CAS-167221-71-8 |
| CC0258 |
| CHEBI:135738 |
| CHEMBL1237132 |
| Clevelox |
| Clevidipine |
| Clevidipine (USAN/INN) |
| Clevidipine [USAN:INN] |
| Clevidipine butyrate |
| Clevidipine, Cleviprex |
| Clevidipine; Methyl (1-oxobutoxy)methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dime thyl-3,5-pyridinedicarboxylate |
| Cleviprex (Clevidipine) |
| Cleviprex (TN) |
| CS-1427 |
| CTK4D2578 |
| D08892 |
| DB04920 |
| DSSTox_CID_31450 |
| DSSTox_GSID_57661 |
| DSSTox_RID_97336 |
| DTXSID6057661 |
| FT-0659562 |
| FT-0688416 |
| GTPL7468 |
| H 324/38 |
| H-324/38 |
| H324/38 |
| HMS3604H21 |
| HMS3651G10 |
| HY-17436 |
| I06-2062 |
| I14-17270 |
| J-520103 |
| KB-53558 |
| KPBZROQVTHLCDU-UHFFFAOYSA-N |
| KS-00000XIM |
| MCULE-6863602192 |
| Methyl (1-oxobutoxy)methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dime thyl-3,5-pyridinedicarboxylate |
| Methyl (1-oxobutoxy)methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate |
| METHYL 5-{[(BUTANOYLOXY)METHOXY]CARBONYL}-4-(2,3-DICHLOROPHENYL)-2,6-DIMETHYL-1,4-DIHYDROPYRIDINE-3-CARBOXYLATE |
| MolPort-020-006-047 |
| NCGC00262928-01 |
| O3-(butanoyloxymethyl) O5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate |
| O5-(butanoyloxymethyl) O3-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate |
| rac-Clevidipine |
| RL02144 |
| s2080 |
| SCHEMBL115522 |
| SR-01000945183 |
| SR-01000945183-1 |
| SR-01000945183-2 |
| SW220087-1 |
| Tox21_113923 |
| W-5232 |
| Z1691545244 |
| Z1845 |
Paragraph IV (Patent) Challenges for CLEVIPREX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CLEVIPREX | EMULSION;INTRAVENOUS | clevidipine | 022156 | 2019-07-02 |
US Patents and Regulatory Information for CLEVIPREX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chiesi Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Chiesi Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Chiesi Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Chiesi Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start 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 Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | Start Trial | Start Trial |
| Chiesi Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | Start Trial | Start Trial |
| Chiesi Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CLEVIPREX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2012051116 | Start Trial |
| Slovakia | 55996 | Start Trial |
| Estonia | 03230 | Start Trial |
| Poland | 2627173 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CLEVIPREX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0726894 | C00726894/01 | Switzerland | Start Trial | PRODUCT NAME: RACEMISCHES CLEVIDIPINBUTYRAT; REGISTRATION NO/DATE: SWISSMEDIC 60117 11.06.2010 |
| 0726894 | 1290008-0 | Sweden | Start Trial | PRODUCT NAME: CLEVIDIPINE; NAT. REG. NO/DATE: 42321 20120120; FIRST REG.: GB PL 16881/0003 20111123 |
| 0726894 | SPC/GB12/011 | United Kingdom | Start Trial | PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123 |
| 0726894 | 92209 | Luxembourg | Start 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 |
