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Patent details

2015C040 Product name: N-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1H-quinoline-3-carboxamide of een farmaceutisch aanvaardbaar zout daarvan

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Basic information

Application number:
2015C/040
Type:
Certificate
SPC type:
Medical
Basic patent number:
057910606
Status:
Active
Publication number:
2015C040
1rst applicant's nationality:
Procedural language:
Dutch

Paediatric extension

SPC Extension filing date:
18/07/2025
SPC Extension agent/owner name:
GEVERS PATENTS , Vertex Pharmaceuticals Incorporated
SPC Extension status:
Open & Published
SPC Extension grant date:
SPC Extension Rejection Date:

Marketing authorization

Marketing authorization number:
EU/1/12/782/001-002
Marketing authorization type:
National/EU
Designates country:
Yes
Marketing authorization date:
25/07/2012
Marketing authorization status:
Accepted
Marketing authorization country:
Belgium (BE)

Dates

Filing date:
06/07/2015
First marketing authorization date:
25/07/2012
Grant date:
08/10/2024
Activation date:
24/06/2025
BE Publication date:
15/07/2015
Lapsed date:
Expiration date (if granted and all annual fees paid):
Basic SPC Expiration (if granted and all annual fees paid):
25/07/2027
SPC/SPC Extension Expiration (if granted and all annual fees paid):
25/01/2028
Rejection date:
Withdrawal date:

Applicant

Name:
Vertex Pharmaceuticals Incorporated
Legal Form:
Inc.
From:
18/07/2025
Address:
50 Northern Avenue, MA 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:
15/07/2015
Address:
Pieter van Reysschootlaan 2, bus 0102, 9051, GENT, Belgium (BE)
To:
28/08/2017

3

Name:
FOX IP LAW
Legal Form:
From:
19/05/2021
Address:
Zonnelaan 19, 9620, ZOTTEGEM, Belgium (BE)
To:
30/05/2023

4

Name:
CAPPUYNS Patricia
Legal Form:
From:
30/05/2023
Address:
Waterloolaan 16 / 05, 1000, BRUSSEL, Belgium (BE)
To:
19/07/2024

5

Name:
CAPPUYNS Patricia
Legal Form:
From:
28/08/2017
Address:
Amelia Earhartlaan 19, bus 0202, 9051, GENT, Belgium (BE)
To:
02/07/2019

6

Name:
CAPPUYNS Patricia
Legal Form:
From:
02/07/2019
Address:
Zonnelaan 19, 9620, ZOTTEGEM, Belgium (BE)
To:
19/05/2021

Publication

Bulletin

1

Bulletin heading:
SPC
Journal edition number:
2024/19
Publication date:
09/12/2024
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

2

Bulletin heading:
SPC
Journal edition number:
2025/12
Publication date:
21/08/2025
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

3

Bulletin heading:
SPC
Journal edition number:
2025/14
Publication date:
04/09/2025
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

Annual fee

Annual fee(s) Due Date:
30/06/2026
Annual fee number:
22
Annual fee amount:
700 Euro
Expected payer:
Last annual fee payment date:
16/05/2025
Last annual fee paid number:
21
Last annual fee paid amount:
650 Euro
Payer:
C.P.A.
Filing date Document type Publication Type Document Description Number of pages File Type
15/07/2015 Publication I1 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_0_i1document_20150715_094204257.pdf
19/05/2021 Outgoing Correspondence Outgoing Correspondence 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_1_134813_pie.rfc.man.not.pdf
06/07/2015 General Document Other 2 PDF /2/1/0/8/4/0721448012/docs/2015c040_2_generaldocument_20150728_031555734.pdf
06/07/2015 General Document Other 35 PDF /2/1/0/8/4/0721448012/docs/2015c040_3_generaldocument_20150714_122811016.pdf
30/05/2023 Request For Change Letter and/or Form requesting a change in the Register 2 PDF /2/1/0/8/4/0721448012/docs/2015c040_4_rfc_20230531_023732345.pdf
23/06/2023 Outgoing Correspondence 2 PDF /2/1/0/8/4/0721448012/docs/2015c040_5_outgoingcorrespondence_20230703_020316355.pdf
30/05/2023 Request For Change Letter and/or Form requesting a change in the Register 2 PDF /2/1/0/8/4/0721448012/docs/2015c040_6_rfc_20231030_033325912.pdf
18/07/2025 General Document Other 3 PDF /2/1/0/8/4/0721448012/docs/2015c040_7_generaldocument_20250719_084535407.pdf
18/07/2025 Application Form 3 PDF /2/1/0/8/4/0721448012/docs/2015c040_8_applicationform_20250719_084537196.pdf
18/07/2025 Paediatric Investigation Plan Paediatric Investigation Plan (PIP) 2 PDF /2/1/0/8/4/0721448012/docs/2015c040_9_paediatricinvestigationplan_20250719_084536661.pdf
18/07/2025 Power Of Attorney Power of attorney 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_10_powerofattorney_20250719_084535614.pdf
18/07/2025 General Document Other 11 PDF /2/1/0/8/4/0721448012/docs/2015c040_11_generaldocument_20250719_084535693.pdf
18/07/2025 General Document Other 89 PDF /2/1/0/8/4/0721448012/docs/2015c040_12_generaldocument_20250719_084535976.pdf
18/07/2025 General Document Other 61 PDF /2/1/0/8/4/0721448012/docs/2015c040_13_generaldocument_20250719_084535807.pdf
18/07/2025 General Document Other 150 PDF /2/1/0/8/4/0721448012/docs/2015c040_14_generaldocument_20250719_084536741.pdf
18/07/2025 Marketing Authorization 1st Paediatric Marketing Authorization (EU) 3 PDF /2/1/0/8/4/0721448012/docs/2015c040_15_marketingauthorization_20250719_084537027.pdf
22/07/2025 Publication I1E 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_16_i1edocument_20250722_103643662.pdf
22/07/2025 Outgoing Correspondence 2 PDF /2/1/0/8/4/0721448012/docs/2015c040_17_outgoingcorrespondence_20250722_033712413.pdf
02/07/2019 Request For Change Letter and/or Form requesting a change in the Register 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_18_rfc_20190704_013410589.pdf
06/07/2015 Power Of Attorney Power of attorney 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_19_powerofattorneyspecific_20150714_122810882.pdf
08/10/2024 Publication I2 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_20_i2document_20241008_151323323.pdf
08/10/2024 Outgoing Correspondence 2 PDF /2/1/0/8/4/0721448012/docs/2015c040_21_outgoingcorrespondence_20241125_101538308.pdf
19/07/2024 Request For Change Other 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_22_rfc_20240720_084538927.pdf
19/07/2024 Outgoing Correspondence 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_23_outgoingcorrespondence_20240720_084538500.pdf
19/07/2024 Request For Change Letter and/or Form requesting a change in the Register 3 PDF /2/1/0/8/4/0721448012/docs/2015c040_24_rfc_20240720_084538605.pdf
19/07/2024 Request For Change Power of attorney deed 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_25_rfc_20240720_084538789.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 2 PDF /2/1/0/8/4/0721448012/docs/2015c040_26_201819_pie.rfc.per.notif.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_27_201821_pie.rfc.man.not.anc.notif.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_28_201822_pie.rfc.man.not.anc.notif.pdf
19/07/2024 Incoming Correspondence (Email) Cover letter 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_29_incomingcorrespondenceelectronic_20240720_084539030.pdf
27/08/2024 Request For Change Other 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_30_rc2024100601_report_20240827.pdf
19/07/2024 Request For Change Letter and/or Form requesting a change in the Register 3 PDF /2/1/0/8/4/0721448012/docs/2015c040_31_rfc_20240720_084538605.pdf
19/07/2024 Request For Change Power of attorney deed 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_32_rfc_20240720_084538789.pdf
19/07/2024 Request For Change Other 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_33_rfc_20240720_084538927.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 2 PDF /2/1/0/8/4/0721448012/docs/2015c040_34_201819_pie.rfc.per.notif.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_35_201821_pie.rfc.man.not.anc.notif.pdf
27/08/2024 Outgoing Correspondence Outgoing Correspondence 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_36_201822_pie.rfc.man.not.anc.notif.pdf
19/07/2024 Incoming Correspondence (Email) Cover letter 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_37_incomingcorrespondenceelectronic_20240720_084539030.pdf
19/07/2024 Outgoing Correspondence Outgoing Correspondence 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_38_outgoingcorrespondence_20240720_084538500.pdf
28/08/2017 Request For Change Letter and/or Form requesting a change in the Register 1 PDF /2/1/0/8/4/0721448012/docs/2015c040_39_rfc_20170829_034139866.pdf
06/07/2015 Application Form 4 PDF /2/1/0/8/4/0721448012/docs/2015c040_40_applicationform_20150714_122810788.pdf