Patent details

92681 Product Name: Nintédanib, ses tautomères et ses sels, en particulier Nintédanib et ses sels pharmaceutiquement acceptables, en particulier Nintédanib Esilate

Basic Information

Publication number:
92681
Type:
SPC
SPC Type:
Medical
Basic Patent Number:
EP009713470
Legal Status:
Active
Application number:
92681
First applicant's nationality:
Procedural language:
French

Paediatric Extension

SPC Extension Filing Date:
28/09/2023
SPC Extension Agent Name:
ARONOVA S.A.
SPC Extension Status:
Granted
SPC Extension Grant Date:
04/10/2024
SPC Extension Rejection Date:

Marketing Authorization

Marketing Authorization Number:
EU/1/14/954/001-004 Vargatef- nintédanib
Marketing Authorization Type:
Marketing Authorization Date:
25/11/2014
Marketing Authorization Status:
Accepted
Marketing Authorization Country:
Luxembourg (LU)

Dates

Filing date:
16/03/2015
First Marketing Authorization date:
25/11/2014
Grant date:
18/05/2015
Activation date:
09/10/2020
Publication date:
18/05/2015
Lapsed date:
Expiration date:
Renunciation date:
Revocation date:
Annulment date:
Basic SPC Expiration:
09/10/2025
SPC Extension Expiration:
09/04/2026
Rejection date:
Withdrawal date:

Owner

From:
16/03/2015
 
 

Name:
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG
Address:
BINGER STRASSE 173, 55216 INGELHEIM AM RHEIN, Germany (DE)

Agent

Name:
ARONOVA S.A.
From:
16/03/2015
Address:
PO Box 327, 4004, ESCH-SUR-ALZETTE, Luxembourg (LU)
To:

Inventor

1

Name:
WALTER Rainer
Address:
Germany (DE)

2

Name:
TONTSCH-GRUNT Ulrike
Address:
Austria (AT)

3

Name:
VAN MEEL Jacobus
Address:
Austria (AT)

4

Name:
HILBERG Frank
Address:
Austria (AT)

5

Name:
SPEVAK Walter
Address:
Austria (AT)

6

Name:
HECKEL Armin
Address:
Germany (DE)

7

Name:
REDEMANN Norbert
Address:
Germany (DE)

8

Name:
ROTH Gerald, Jürgen
Address:
Germany (DE)

Publication

Bulletin

1

Bulletin Heading:
SPC4
Bulletin edition number:
2019/02
Publication date:
22/02/2019
Description:
Section F : Correction of granted supplementary protection certificates – I9 publication

2

Bulletin Heading:
SPC3
Bulletin edition number:
2020/12
Publication date:
02/11/2020
Description:
Section E : Supplementary Protection certificates entered into force – IA publication

3

Bulletin Heading:
SPCX1
Bulletin edition number:
2023/11
Publication date:
05/10/2023
Description:
Section G : Applications for extensions for pediatric use – I1E publication

4

Bulletin Heading:
SPCX2
Bulletin edition number:
2024/13
Publication date:
05/11/2024
Description:
Section H : Granted extensions for pediatric use of supplementary protection certificates – I2E publication

Annual Fees

Annual Fee Due Date:
Annual Fee Number:
Expected Payer:
Last Annual Fee Payment Date:
21/10/2024
Last Annual Fee Paid Number:
25
Last Annual Fee Paid Amount:
450 Euro
Payer:
DENNEMEYER & CO
Filing date Document type Number of pages
17/01/2018 Incoming Correspondence (Post) 2
03/01/2019 Outgoing Correspondence 1
14/09/2018 Incoming Correspondence (Post) 1
03/01/2019 Publication 1
28/09/2023 Application Form 4
28/09/2023 Marketing authorization 3
28/09/2023 Summary of the product caracteristics 65
28/09/2023 Paediatric investigation plan 5
28/09/2023 Paediatric investigation plan 1
28/09/2023 Marketing authorization 9
28/09/2023 Marketing authorization 10
28/09/2023 Marketing authorization 3
28/09/2023 General Document 4
28/09/2023 Marketing authorization 7
28/09/2023 Marketing authorization 3
28/09/2023 Marketing authorization 8
28/09/2023 General Document 3
28/09/2023 Outgoing Correspondence 1
28/09/2023 Publication 1
04/10/2024 Publication 1
04/10/2024 Certificate 1
28/09/2023 FNET_DC_FRONTPAGE 1
04/10/2024 Outgoing Correspondence 1