Patent details

92943 Product Name: Ceftolozane ou un sel pharmaceutiquement acceptable, en particulier un sel d'acide sulfurique (ZERBAXA)

Basic Information

Publication number:
92943
Type:
SPC
SPC Type:
Medical
Basic Patent Number:
EP037589199
Legal Status:
Active
Application number:
92943
First applicant's nationality:
Procedural language:
French

Paediatric Extension

SPC Extension Filing Date:
10/11/2022
SPC Extension Agent Name:
OFFICE FREYLINGER S.A.
SPC Extension Status:
Granted
SPC Extension Grant Date:
21/10/2024
SPC Extension Rejection Date:

Marketing Authorization

Marketing Authorization Number:
EU/1/15/1032 - Zerbaxa - ceftolozane/tazobactam
Marketing Authorization Type:
Marketing Authorization Date:
22/09/2015
Marketing Authorization Status:
Accepted
Marketing Authorization Country:

Dates

Filing date:
12/01/2016
First Marketing Authorization date:
22/09/2015
Grant date:
14/03/2016
Activation date:
27/10/2023
Publication date:
14/03/2016
Lapsed date:
Expiration date:
Renunciation date:
Revocation date:
Annulment date:
Basic SPC Expiration:
27/10/2028
SPC Extension Expiration:
27/04/2029
Rejection date:
Withdrawal date:

Owner

From:
12/01/2016
 
 

Name:
Astellas Pharma Inc.
Address:
3-11, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 103-8411, Japan (JP)

Name:
WAKUNAGA PHARMACEUTICAL CO. LTD.
Address:
5-36, Miyahara 4-chome, Yodogawa-ku, Osaka-shi, Osaka 532-0003, Japan (JP)

Agent

Name:
OFFICE FREYLINGER S.A.
From:
12/01/2016
Address:
Boîte Postale 48, L-8001, STRASSEN, Luxembourg (LU)
To:

Inventor

1

Name:
SATOH Kenji, Wakunaga Pharmaceutical Co., Ltd.
Address:
Japan (JP)

2

Name:
OKUDA Shinya, c/o Astellas Pharma Inc.
Address:
Japan (JP)

3

Name:
MISUMI Keiji, Wakunaga Pharmaceutical Co., Ltd.
Address:
Japan (JP)

4

Name:
YAMANAKA Toshio, c/o Astellas Pharma Inc.
Address:
Japan (JP)

5

Name:
KAWABATA Kohji, c/o Astellas Pharma Inc.
Address:
Japan (JP)

6

Name:
ITOH Kenji, Wakunaga Pharmaceutical Co., Ltd.
Address:
Japan (JP)

7

Name:
OHGAKI Masaru, c/o Astellas Pharma Inc.
Address:
Japan (JP)

8

Name:
OHKI Hidenori, c/o Astellas Pharma Inc.
Address:
Japan (JP)

9

Name:
TODA Ayako, c/o Astellas Pharma Inc.
Address:
Japan (JP)

10

Name:
INOUE Satoshi, Wakunaga Pharmaceutical Co., Ltd.
Address:
Japan (JP)

Publication

Bulletin

1

Bulletin Heading:
SPCX1
Bulletin edition number:
2022/13
Publication date:
01/12/2022
Description:
Section G : Applications for extensions for pediatric use – I1E publication

2

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

3

Bulletin Heading:
SPC3
Bulletin edition number:
2025/04
Publication date:
04/03/2025
Description:
Section E : Supplementary Protection certificates entered into force – IA publication

Annual Fees

Annual Fee Due Date:
02/11/2026
Annual Fee Number:
24
Annual Fee Amount:
440 Euro
Expected Payer:
Last Annual Fee Payment Date:
14/10/2025
Last Annual Fee Paid Number:
23
Last Annual Fee Paid Amount:
430 Euro
Payer:
OFFICE FREYLINGER S.A.
Filing date Document type Number of pages
21/10/2024 Publication 1
21/10/2024 Certificate 1
22/10/2024 Outgoing Correspondence 1
10/11/2022 Application Form 3
10/11/2022 Marketing authorization 3
10/11/2022 General Document 2
10/11/2022 Summary of the product caracteristics 37
10/11/2022 Paediatric investigation plan 127
10/11/2022 Paediatric investigation plan 1
10/11/2022 FNET_DC_FRONTPAGE 1
10/11/2022 Publication 1
10/11/2022 Outgoing Correspondence 1