IVACAFTOR; IVACAFTOR, TEZACAFTOR - Generic Drug Details
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What are the generic drug sources for ivacaftor; ivacaftor, tezacaftor and what is the scope of freedom to operate?
Ivacaftor; ivacaftor, tezacaftor
is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivacaftor; ivacaftor, tezacaftor has four hundred and eighteen patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for IVACAFTOR; IVACAFTOR, TEZACAFTOR
| International Patents: | 418 |
| US Patents: | 25 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 44 |
| DailyMed Link: | IVACAFTOR; IVACAFTOR, TEZACAFTOR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IVACAFTOR; IVACAFTOR, TEZACAFTOR
*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 IVACAFTOR; IVACAFTOR, TEZACAFTOR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of North Carolina, Chapel Hill | Phase 4 |
| Chiesi USA, Inc. | Phase 4 |
| The Marcus Foundation, Inc. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for IVACAFTOR; IVACAFTOR, TEZACAFTOR
US Patents and Regulatory Information for IVACAFTOR; IVACAFTOR, TEZACAFTOR
International Patents for IVACAFTOR; IVACAFTOR, TEZACAFTOR
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | PI0916877 | ⤷ Sign Up | |
| Denmark | 2464337 | ⤷ Sign Up | |
| Poland | 2502911 | ⤷ Sign Up | |
| Slovenia | 2328618 | ⤷ Sign Up | |
| Portugal | 3424534 | ⤷ Sign Up | |
| Serbia | 61314 | ÄVRSTA DISPERZIJA AMORFNOG OBLIKA (R)-1(2,2-DIFLUOROBENZO(D)(1,3)DIOKSOL-5-IL)-N-(1-(2,3-DIHIDROKSIPROPIL)-6-FLUORO-2-(1-HIDROKSI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL)-CIKLOPROPANKARBOKSAMIDA (SOLID DISPERSION OF AMORPHOUS FORM OF (R)-1(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)-CYCLOPROPANECARBOXAMIDE) | ⤷ Sign Up |
| Japan | 2012107069 | MODULATOR OF ATP-BINDING CASSETTE TRANSPORTER | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IVACAFTOR; IVACAFTOR, TEZACAFTOR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1773816 | 300748 | Netherlands | ⤷ Sign Up | PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE (INN: IVACAFTOR) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
| 2826776 | CR 2021 00013 | Denmark | ⤷ Sign Up | PRODUCT NAME: EN KOMBINATION AF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG (B) ....; REG. NO/DATE: EU/1/18/1306 20181106 |
| 2826776 | 13/2021 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL) CYCLOPROPANCARBOXAMID UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYLPHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID; REGISTRATION NO/DATE: EU/1/18/1306 (MITTEILUNG) 20181106 |
| 2826776 | LUC00207 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106 |
| 1773816 | 1590036-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/12/782/001 20120725 |
| 2826776 | CA 2021 00013 | Denmark | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) ....; REG. NO/DATE: EU/1/18/1306 20181106 |
| 2826776 | PA2021508,C2826776 | Lithuania | ⤷ Sign Up | PRODUCT NAME: (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOKSOL-5-IL)-N-(1-(2,3-DIHIDROKSIPROPIL)-6-FLUOR-2-(1-HIDROKSI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL) CIKLOPROPANKARBOKSAMIDO ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS IR (B) N-(5-HIDROKSI-2,4-DITERT-BUTIL-FENIL)-4-OKSO-1H-CHINOLIN-3-KARBOKSAMIDO ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/18/1306 20181031 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
