Patent details

301239 Product Name: etranacogene dezaparvovec (an adeno-associated viral vector containing a codon-optimized Padua derivative of human coagulation factor IX gene for the treatment of hemophilia B)

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Basic Information

Publication number:
301239
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP3581650
Status:
Application Pending
Application number:
301239
Procedural language:
Dutch
First Applicant Residence Country:
Netherlands (NL)

Marketing Authorization

Marketing Authorization Number:
EU/1/22/1715
Marketing Authorization Type:
EEA
Marketing Authorization Date:
23/02/2023
Marketing Authorization Country:
European Union (EU)

Dates

Filing date:
26/07/2023
First Marketing Authorization date:
23/02/2023
Grant date:
Activation date:
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
28/07/2023
SPC/SPC Extension Expiration Date:
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:

Applicant/holder

From:
26/07/2023
 
 

 

Name:
uniQure biopharma B.V.
Address:
Paasheuvelweg 25a, 1105 BP Amsterdam, Netherlands (NL)

Agent

1

Name:
ir. B.Ch. Ledeboer c.s
From:
15/01/2025
Address:
V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
To:

2

Name:
drs. J. Renes
From:
19/01/2024
Address:
Simmons & Simmons LLP Claude Debussylaan 247, 1083 MC, Amsterdam, Netherlands (NL)
To:
15/01/2025

3

Name:
B. Berghuis van Woortman
From:
26/07/2023
Address:
Simmons & Simmons Claude Debussylaan 247, 1082 MC, Amsterdam, Netherlands (NL)
To:
19/01/2024

Publication

Bulletin

Bulletin Heading:
SPC
Journal edition number:
31/23
Publication date:
02/08/2023
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
Filing date Document type Document Description Number of pages File Type
12/03/2025 Incoming Correspondence Paper Accompanying letter incoming document 1 PDF /5/1/9/2/0/0800902915/docs/301239_11_incomingcorrespondencepaper20250312035936201.pdf
12/03/2025 SPC Documents Marketing Authorization SPC 4 PDF /5/1/9/2/0/0800902915/docs/301239_12_supplprotectioncertificate20250312035936231.pdf
28/07/2023 Outgoing Correspondence Confirmation receipt request 2 PDF /5/1/9/2/0/0800902915/docs/301239_2_558545l174.pdf
26/07/2023 SPC Documents Annex SPC 2 PDF /5/1/9/2/0/0800902915/docs/301239_0_supplprotectioncertificate20230728023606693.pdf
26/07/2023 SPC Documents Annex SPC 8 PDF /5/1/9/2/0/0800902915/docs/301239_1_supplprotectioncertificate20230728023606735.pdf
26/07/2023 SPC Documents Annex SPC 2 PDF /5/1/9/2/0/0800902915/docs/301239_3_supplprotectioncertificate20230727033209218.pdf
26/07/2023 Application Form First filed application form 3 PDF /5/1/9/2/0/0800902915/docs/301239_4_applicationform20230727032825581.pdf
26/07/2023 SPC Documents Summary of the characteristics of the product 22 PDF /5/1/9/2/0/0800902915/docs/301239_5_supplprotectioncertificate20230727033352472.pdf
26/07/2023 SPC Documents Accompanying letter SPC 4 PDF /5/1/9/2/0/0800902915/docs/301239_6_supplprotectioncertificate20230727033318035.pdf
26/07/2023 SPC Documents Marketing Authorization SPC 4 PDF /5/1/9/2/0/0800902915/docs/301239_7_supplprotectioncertificate20230727033424815.pdf
26/07/2023 SPC Documents Annex SPC 5 PDF /5/1/9/2/0/0800902915/docs/301239_8_supplprotectioncertificate20230727033501423.pdf
26/07/2023 SPC Documents Annex SPC 18 PDF /5/1/9/2/0/0800902915/docs/301239_9_supplprotectioncertificate20230727033103803.pdf
26/07/2023 SPC Documents Annex SPC 17 PDF /5/1/9/2/0/0800902915/docs/301239_10_supplprotectioncertificate20230727032952843.pdf