Patent details

92600 Product Name: Sovaldi (sofosbuvir)

Basic Information

Publication number:
92600
Type:
SPC
SPC Type:
Medical
Basic Patent Number:
EP087328183
Legal Status:
Inactive
Application number:
92600
First applicant's nationality:
Procedural language:
French

Paediatric Extension

SPC Extension Filing Date:
22/07/2021
SPC Extension Agent Name:
MARKS & CLERK LLP
SPC Extension Status:
Pending & Published
SPC Extension Grant Date:
SPC Extension Rejection Date:

Marketing Authorization

Marketing Authorization Number:
EU/1/13/894(001-002) - Sovaldi - sofosbuvir
Marketing Authorization Type:
Marketing Authorization Date:
17/01/2014
Marketing Authorization Status:
Accepted
Marketing Authorization Country:

Dates

Filing date:
19/11/2014
First Marketing Authorization date:
17/01/2014
Grant date:
24/11/2015
Activation date:
Publication date:
24/11/2015
Lapsed date:
Expiration date:
Renunciation date:
Revocation date:
Annulment date:
Basic SPC Expiration:
17/01/2029
SPC Extension Expiration:
17/07/2029
Rejection date:
Withdrawal date:

Owner

From:
19/11/2014
 
 

Name:
Gilead Pharmasset LLC
Address:
Gilead Sciences, Inc. 333 Lakeside Drive, Foster City, CA 94404, United States (US)

Agent

Name:
MARKS & CLERK LLP
From:
19/11/2014
Address:
BP 1775, 1017, LUXEMBOURG, Luxembourg (LU)
To:

Inventor

1

Name:
WANG Peiyuan
Address:
United States (US)

2

Name:
NAGARATHNAM Dhanapalan
Address:
United States (US)

3

Name:
SOFIA Michael, Joseph
Address:
United States (US)

4

Name:
DU Jinfa
Address:
United States (US)

Publication

Bulletin

Bulletin Heading:
SPCX1
Bulletin edition number:
2021/09
Publication date:
03/08/2021
Description:
Section G : Applications for extensions for pediatric use – I1E publication

Annual Fees

Annual Fee Due Date:
31/03/2028
Annual Fee Number:
21
Annual Fee Amount:
410 Euro
Expected Payer:
Last Annual Fee Payment Date:
Last Annual Fee Paid Number:
Payer:
Filing date Document type Number of pages
22/07/2021 Summary of the product caracteristics 91
22/07/2021 Marketing authorization 4
22/07/2021 Marketing authorization 3
22/07/2021 Marketing authorization 53
22/07/2021 Application Form 3
22/07/2021 General Document 2
26/07/2021 Publication 1
22/07/2021 Incoming Correspondence (Post) 2
22/07/2021 MA publication 3
26/07/2021 Outgoing Correspondence 1
26/07/2021 FNET_DC_FRONTPAGE 1
22/07/2021 General Document 1
12/08/2022 Request For Change 1
02/09/2022 Outgoing Correspondence 56
04/11/2024 Paediatric investigation plan 1
21/10/2024 Outgoing Correspondence 1
10/02/2025 Administration 1
10/02/2025 Outgoing Correspondence 1