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Patent details

2021C517 Product name: "Symkevi - tezacaftor/ivacaftor"; een combinatie van (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 of een vanuit farmaceutisch oogpunt geschikt zout daarvan en (b) N-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1H-quinoline-3-carboxamide of een vanuit farmaceutisch oogpunt geschikt zout daarvan.

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Basic information

Application number:
2021C/517
Type:
Certificate
SPC type:
Medical
Basic patent number:
141729913
Status:
Open & Published
Publication number:
2021C517
1rst applicant's nationality:
Procedural language:
Dutch

Marketing authorization

Marketing authorization number:
EU/1/18/1306
Marketing authorization type:
National/EU
Designates country:
No
Marketing authorization date:
06/11/2018
Marketing authorization status:
Accepted
Marketing authorization country:
Belgium (BE)

Dates

Filing date:
21/05/2021
First marketing authorization date:
06/11/2018
Grant date:
Activation date:
BE Publication date:
25/05/2021
Lapsed date:
Expiration date (if granted and all annual fees paid):
Basic SPC Expiration (if granted and all annual fees paid):
06/11/2033
SPC/SPC Extension Expiration (if granted and all annual fees paid):
06/11/2033
Rejection date:
Withdrawal date:

Applicant

Name:
Vertex Pharmaceuticals Incorporated
Legal Form:
«Incorporated » vennootschap naar Amerikaans recht
From:
25/05/2021
Address:
50 Northern Avenue, 02210, Boston, United States (US)
To:

Agent

1

Name:
GEVERS PATENTS
Legal Form:
From:
19/07/2024
Address:
De Kleetlaan 7A, 1831, DIEGEM, Belgium (BE)
To:

2

Name:
CAPPUYNS Patricia
Legal Form:
From:
25/05/2021
Address:
Waterloolaan 16 / 05, 1000, BRUSSEL, Belgium (BE)
To:
24/10/2022

3

Name:
FOX IP LAW
Legal Form:
From:
24/10/2022
Address:
Zonnelaan 19, 9620, ZOTTEGEM, Belgium (BE)
To:
19/07/2024

Publication

Bulletin

Bulletin heading:
SPC
Journal edition number:
2021/10
Publication date:
28/06/2021
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

Annual fee

Annual fee(s) Due Date:
31/03/2031
Annual fee number:
21
Annual fee amount:
650 Euro
Expected payer:
Last annual fee payment date:
Last annual fee paid number:
Payer:
Filing date Document type Publication Type Document Description Number of pages File Type
25/05/2021 Front Page 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_0_i1frontpage_20210525_092444799.pdf
21/05/2021 General Document Other 68 PDF /4/0/3/5/2/0722125304/docs/2021c517_1_generaldocument_20210522_084819668.pdf
24/10/2022 Request For Change Letter and/or Form requesting a change in the Register 2 PDF /4/0/3/5/2/0722125304/docs/2021c517_2_rfc_20230310_040657252.pdf
25/05/2021 Publication I1 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_3_i1document_20210525_092445406.pdf
21/05/2021 MA Official Publication Official Publication of 1st Marketing Authorization 13 PDF /4/0/3/5/2/0722125304/docs/2021c517_4_maofficialpublication_20210522_084828623.pdf
09/06/2021 Outgoing Correspondence 2 PDF /4/0/3/5/2/0722125304/docs/2021c517_5_outgoingcorrespondence_20210609_022449969.pdf
21/05/2021 Abstract Product Characteristics Abstract of the characteristics of the product 19 PDF /4/0/3/5/2/0722125304/docs/2021c517_6_abstractproductcharacteristics_20210522_084823248.pdf
21/05/2021 General Document Other 122 PDF /4/0/3/5/2/0722125304/docs/2021c517_7_generaldocument_20210522_084818109.pdf
21/05/2021 Power Of Attorney Power of attorney 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_8_powerofattorney_20210522_084822355.pdf
24/10/2022 Request For Change Letter and/or Form requesting a change in the Register 2 PDF /4/0/3/5/2/0722125304/docs/2021c517_9_rfc_20221026_101533170.pdf
21/05/2021 Application Form 3 PDF /4/0/3/5/2/0722125304/docs/2021c517_10_applicationform_20210522_084831050.pdf
21/05/2021 Marketing Authorization 1st Marketing Authorization (EU) 42 PDF /4/0/3/5/2/0722125304/docs/2021c517_11_marketingauthorization_20210522_084825511.pdf
19/07/2024 Request For Change Letter and/or Form requesting a change in the Register 3 PDF /4/0/3/5/2/0722125304/docs/2021c517_12_rfc_20240720_084538605.pdf
19/07/2024 Request For Change Power of attorney deed 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_13_rfc_20240720_084538789.pdf
19/07/2024 Request For Change Other 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_14_rfc_20240720_084538927.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 2 PDF /4/0/3/5/2/0722125304/docs/2021c517_15_201819_pie.rfc.per.notif.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_16_201821_pie.rfc.man.not.anc.notif.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_17_201822_pie.rfc.man.not.anc.notif.pdf
19/07/2024 Incoming Correspondence (Email) Cover letter 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_18_incomingcorrespondenceelectronic_20240720_084539030.pdf
19/07/2024 Outgoing Correspondence 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_19_outgoingcorrespondence_20240720_084538500.pdf
27/08/2024 Request For Change Other 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_20_rc2024100601_report_20240827.pdf
19/07/2024 Request For Change Letter and/or Form requesting a change in the Register 3 PDF /4/0/3/5/2/0722125304/docs/2021c517_21_rfc_20240720_084538605.pdf
19/07/2024 Request For Change Power of attorney deed 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_22_rfc_20240720_084538789.pdf
19/07/2024 Request For Change Other 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_23_rfc_20240720_084538927.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 2 PDF /4/0/3/5/2/0722125304/docs/2021c517_24_201819_pie.rfc.per.notif.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_25_201821_pie.rfc.man.not.anc.notif.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_26_201822_pie.rfc.man.not.anc.notif.pdf
19/07/2024 Incoming Correspondence (Email) Cover letter 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_27_incomingcorrespondenceelectronic_20240720_084539030.pdf
19/07/2024 Outgoing Correspondence Outgoing Correspondence 1 PDF /4/0/3/5/2/0722125304/docs/2021c517_28_outgoingcorrespondence_20240720_084538500.pdf