Ivacaftor; ivacaftor, tezacaftor - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for ivacaftor; ivacaftor, tezacaftor and what is the scope of patent protection?
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-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivacaftor; ivacaftor, tezacaftor has four hundred and fifteen patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for ivacaftor; ivacaftor, tezacaftor
International Patents: | 415 |
US Patents: | 24 |
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
Generic Entry Date for ivacaftor; ivacaftor, tezacaftor*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, TABLET;ORAL |
*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 |
Emory University | 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 |
---|---|---|---|
Croatia | P20180328 | ⤷ Try a Trial | |
Cyprus | 1120045 | ⤷ Try a Trial | |
Hungary | E036165 | ⤷ Try a Trial | |
Spain | 2885181 | ⤷ Try a Trial | |
Spain | 2660143 | ⤷ Try a Trial | |
Mexico | 2021013638 | COMPOSICIONES FARMACEUTICAS PARA EL TRATAMIENTO DE ENFERMEDADES MEDIADAS POR EL REGULADOR DE CONDUCTANCIA DE TRANSMEMBRANA DE FIBROSIS QUISTICA. (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES.) | ⤷ Try a Trial |
>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 | C01773816/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC 62686 13.01.2014 |
2826776 | PA2021508,C2826776 | Lithuania | ⤷ Try a Trial | 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 |
2826776 | 122021000025 | Germany | ⤷ Try a Trial | PRODUCT NAME: EINE 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 ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1306 20181031 |
3170818 | C202030042 | Spain | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINACION DE A) LUMACAFTOR Y B) IVACAFTOR; NATIONAL AUTHORISATION NUMBER: EU/1/15/1059; DATE OF AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1059; DATE OF FIRST AUTHORISATION IN EEA: 20151119 |
1773816 | 122015000050 | Germany | ⤷ Try a Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBONSAEUREAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723 |
1773816 | 300748 | Netherlands | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |