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Patent details

2018C003 Product name: Dupixent - dupilumab

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Basic information

Application number:
2018C/003
Type:
Certificate
SPC type:
Medical
Basic patent number:
097442925
Status:
Open & Published
Publication number:
2018C003
1rst applicant's nationality:
Procedural language:
French

Paediatric extension

SPC Extension filing date:
20/04/2023
SPC Extension agent/owner name:
KIRKPATRICK
SPC Extension status:
Open & Published
SPC Extension grant date:
SPC Extension Rejection Date:

Marketing authorization

Marketing authorization number:
EU/1/17/1229
Marketing authorization type:
National/EU
Designates country:
No
Marketing authorization date:
28/09/2017
Marketing authorization status:
Accepted
Marketing authorization country:
Belgium (BE)

Dates

Filing date:
08/01/2018
First marketing authorization date:
28/09/2017
Grant date:
Activation date:
BE Publication date:
19/01/2018
Lapsed date:
Expiration date (if granted and all annual fees paid):
Basic SPC Expiration (if granted and all annual fees paid):
28/09/2032
SPC/SPC Extension Expiration (if granted and all annual fees paid):
28/03/2033
Rejection date:
Withdrawal date:

Applicant

Name:
Regeneron Pharmaceuticals, Inc.
Legal Form:
From:
19/01/2018
Address:
777 Old Saw Mill River Road, Tarrytown, NY 10591, United States (US)
To:

Agent

1

Name:
KIRKPATRICK
Legal Form:
S.A.
From:
08/10/2018
Address:
Avenue Wolfers 32, 1310, LA HULPE, Brabant wallon, Belgium (BE)
To:

2

Name:
BLOCH Gérard
Legal Form:
From:
19/01/2018
Address:
-, -, -, Belgium (BE)
To:
08/10/2018

Publication

Bulletin

1

Bulletin heading:
SPC
Journal edition number:
2018/02
Publication date:
28/02/2018
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

2

Bulletin heading:
SPC
Journal edition number:
2023/08
Publication date:
09/05/2023
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

Annual fee

Annual fee(s) Due Date:
31/10/2029
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
08/01/2018 Application Form 3 PDF /5/1/3/4/8/0721684315/docs/2018c003_0_applicationform_20180118_034006016.pdf
19/01/2018 Publication I1 1 PDF /5/1/3/4/8/0721684315/docs/2018c003_1_i1document_20180119_135802392.pdf
19/01/2018 General Document Other 2 PDF /5/1/3/4/8/0721684315/docs/2018c003_2_generaldocument_20180122_024619949.pdf
08/01/2018 General Document Other 6 PDF /5/1/3/4/8/0721684315/docs/2018c003_3_generaldocument_20180118_034006574.pdf
08/01/2018 General Document Other 65 PDF /5/1/3/4/8/0721684315/docs/2018c003_4_generaldocument_20180118_034006352.pdf
08/01/2018 General Document Other 3 PDF /5/1/3/4/8/0721684315/docs/2018c003_5_generaldocument_20180118_034006272.pdf
08/01/2018 General Document Other 3 PDF /5/1/3/4/8/0721684315/docs/2018c003_6_generaldocument_20180118_034006109.pdf
08/01/2018 General Document Other 2 PDF /5/1/3/4/8/0721684315/docs/2018c003_7_generaldocument_20180118_034006440.pdf
08/01/2018 General Document Other 4 PDF /5/1/3/4/8/0721684315/docs/2018c003_8_generaldocument_20180118_034006521.pdf
08/01/2018 General Document Other 10 PDF /5/1/3/4/8/0721684315/docs/2018c003_9_generaldocument_20180118_034006193.pdf
08/10/2018 Request For Change Letter and/or Form requesting a change in the Register 1 PDF /5/1/3/4/8/0721684315/docs/2018c003_10_rfc_20181008_032421542.pdf
19/01/2018 Front Page 1 PDF /5/1/3/4/8/0721684315/docs/2018c003_11_i1frontpage_20180119_135801490.pdf
20/04/2023 General Document Other 287 PDF /5/1/3/4/8/0721684315/docs/2018c003_12_generaldocument_20230421_084607663.pdf
20/04/2023 General Document Other 2 PDF /5/1/3/4/8/0721684315/docs/2018c003_13_generaldocument_20230421_084607506.pdf
20/04/2023 Marketing Authorization 1st Paediatric Marketing Authorization (EU) 3 PDF /5/1/3/4/8/0721684315/docs/2018c003_14_marketingauthorization_20230421_084608330.pdf
20/04/2023 General Document Other 2 PDF /5/1/3/4/8/0721684315/docs/2018c003_15_generaldocument_20230421_084608445.pdf
20/04/2023 Paediatric Investigation Plan Paediatric Investigation Plan (PIP) 1 PDF /5/1/3/4/8/0721684315/docs/2018c003_16_paediatricinvestigationplan_20230421_084608606.pdf
20/04/2023 Application Form 3 PDF /5/1/3/4/8/0721684315/docs/2018c003_17_applicationform_20230421_084608741.pdf
21/04/2023 Publication I1E 1 PDF /5/1/3/4/8/0721684315/docs/2018c003_18_i1edocument_20230421_102721855.pdf
21/04/2023 Outgoing Correspondence 2 PDF /5/1/3/4/8/0721684315/docs/2018c003_19_outgoingcorrespondence_20230426_092646008.pdf
13/03/2023 Request For Change Letter and/or Form requesting a change in the Register 1 PDF /5/1/3/4/8/0721684315/docs/2018c003_20_rfc_20230406_120158427.pdf