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CLEVIPREX Drug Profile
When do Cleviprex patents expire, and when can generic versions of Cleviprex launch?
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-four patent family members in thirty-three countries.
The generic ingredient in CLEVIPREX is clevidipine. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the clevidipine profile page.
Summary for CLEVIPREX
| International Patents: | 64 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 66 |
| Clinical Trials: | 12 |
| Patent Applications: | 496 |
| Drug Prices: | Drug price information for CLEVIPREX |
| DailyMed Link: | CLEVIPREX at DailyMed |
Generic Entry Opportunity 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.
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 |
| AK163183 |
| AKOS015896325 |
| AMX10159 |
| AN-16754 |
| AS-19935 |
| 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 (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 |
| HE317022 |
| 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 |
| OR074104 |
| rac-Clevidipine |
| RL02144 |
| s2080 |
| SCHEMBL115522 |
| SR-01000945183 |
| SR-01000945183-1 |
| SR-01000945183-2 |
| Tox21_113923 |
| W-5232 |
| Z1691545244 |
| Z1845 |
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 | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Chiesi Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Chiesi Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Chiesi Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Chiesi Usa Inc | 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 Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-003 | Nov 8, 2013 | ➤ Sign Up | ➤ Sign Up |
| Chiesi Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-001 | Aug 1, 2008 | ➤ Sign Up | ➤ Sign Up |
| Chiesi Usa Inc | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156-002 | Aug 1, 2008 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for CLEVIPREX
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Spain | 2539861 | ➤ Sign Up |
| Hungary | 215591 | ➤ Sign Up |
| Japan | 6040437 | ➤ Sign Up |
| Denmark | 2627173 | ➤ Sign Up |
| Denmark | 0726894 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for CLEVIPREX
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0053 | France | ➤ Sign Up | PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: GB - PL 16881/0003 20111123 |
| 0726894/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: RACEMISCHES CLEVIDIPINBUTYRAT; REGISTRATION NO/DATE: SWISSMEDIC 60117 11.06.2010 |
| 209 | Luxembourg | ➤ Sign Up | PRODUCT NAME: CLEVIDIPINE SOUS TOUTES LES FORMES PROCURANT UNE PROTECTION A PARTIR DU BREVET DE BASE |
| C/GB12/011 | United Kingdom | ➤ Sign Up | PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123 |
| 90008-0 | Sweden | ➤ Sign Up | PRODUCT NAME: CLEVIDIPINE; NAT. REG. NO/DATE: 42321 20120120; FIRST REG.: GB PL 16881/0003 20111123 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
