Patent details

301165 Product Name: diroximelfumaraat

The time of generation of the report may vary depending on the number of the selected files and the pages of each file. If the generation of the consolidated PDF file takes long, you may reduce the number of selected files and proceed with the generation of the PDF in batches.
You have not selected any documents

Basic Information

Publication number:
301165
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP2970101
Status:
SPC granted but not yet in force
Application number:
301165
Procedural language:
Dutch
First Applicant Residence Country:
Ireland (IE)

Marketing Authorization

1

Marketing Authorization Number:
68066
Marketing Authorization Type:
EEA
Marketing Authorization Date:
20/09/2021
Marketing Authorization Country:
Switzerland (CH)

2

Marketing Authorization Number:
EU/1/21/1585
Marketing Authorization Type:
EEA
Marketing Authorization Date:
16/11/2021
Marketing Authorization Country:
European Union (EU)

Dates

Filing date:
17/03/2022
First Marketing Authorization date:
20/09/2021
Grant date:
16/09/2025
Activation date:
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
17/03/2022
SPC/SPC Extension Expiration Date:
19/09/2036
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:

Applicant/holder

From:
17/03/2022
 
 

 

Name:
Alkermes Pharma Ireland Limited
Address:
Connaught House 1 Burlington Road, DUBLIN 4, Ireland (IE)

Agent

1

Name:
ir. B.Ch. Ledeboer c.s
From:
09/01/2025
Address:
V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
To:

2

Name:
ir. H.A. Witmans c.s.
From:
17/03/2022
Address:
V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
To:
09/01/2025

Publication

Bulletin

1

Bulletin Heading:
SPC
Journal edition number:
38/25
Publication date:
17/09/2025
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

2

Bulletin Heading:
SPC
Journal edition number:
12/22
Publication date:
23/03/2022
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

Annual Fee

Annual Fee(s) Due Date:
31/03/2034
Annual Fee Number:
21
Annual Fee Amount:
1600 Euro
Last Annual Payment Date:
Last Annual Fee Paid Number:
Payer:
Filing date Document type Document Description Number of pages File Type
31/10/2025 Incoming Correspondence Electronic Accompanying letter incoming document 1 PDF /8/4/3/6/7/0800776348/docs/301165_10_incomingcorrespondenceelectronic20251031042236840.pdf
31/10/2025 SPC Documents Annex SPC 38 PDF /8/4/3/6/7/0800776348/docs/301165_11_supplprotectioncertificate20251031042236866.pdf
16/09/2025 Outgoing Correspondence Decision grant 1 PDF /8/4/3/6/7/0800776348/docs/301165_8_301165674450l504a.pdf
16/09/2025 Certificate Certificate 1 PDF /8/4/3/6/7/0800776348/docs/301165_9_spcmedcertificate20250916152106310.pdf
17/03/2022 Outgoing Correspondence Confirmation receipt request 1 PDF /8/4/3/6/7/0800776348/docs/301165_0_469032l174.pdf
17/03/2022 Application Form First filed application form 3 PDF /8/4/3/6/7/0800776348/docs/301165_1_applicationform20220317013135701.pdf
17/03/2022 SPC Documents Annex SPC 2 PDF /8/4/3/6/7/0800776348/docs/301165_2_supplprotectioncertificate20220317013748851.pdf
17/03/2022 SPC Documents Annex SPC 15 PDF /8/4/3/6/7/0800776348/docs/301165_3_supplprotectioncertificate20220317013748820.pdf
17/03/2022 SPC Documents Annex SPC 2 PDF /8/4/3/6/7/0800776348/docs/301165_4_supplprotectioncertificate20220317013748795.pdf
17/03/2022 SPC Documents Summary of the characteristics of the product 21 PDF /8/4/3/6/7/0800776348/docs/301165_5_supplprotectioncertificate20220317013748763.pdf
17/03/2022 SPC Documents Marketing Authorization SPC 3 PDF /8/4/3/6/7/0800776348/docs/301165_6_supplprotectioncertificate20220317013748734.pdf
17/03/2022 SPC Documents Accompanying letter SPC 2 PDF /8/4/3/6/7/0800776348/docs/301165_7_supplprotectioncertificate20220317013748709.pdf