Patent details
300803 Product Name: Tenofoviralafenamide of een zout of solvaat daarvan, met name tenofoviralafenamidefumaraat.
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Basic Information
- Publication number:
- 300803
- Type:
- Certificate
- SPC Type:
- Medical
- Basic Patent Number:
- EP1301519
- Status:
- SPC in force
- Application number:
- 300803
- Procedural language:
- Dutch
- First Applicant Residence Country:
- United States of America (US)
Paediatric Extension
- SPC Extension Filing Date:
- 04/01/2023
- SPC Extension Agent/Owner Name:
- GILEAD SCIENCES, INC. , ir. H.A. Witmans c.s.
- SPC Extension Status:
- Extension Granted
- SPC Extension Grant Date:
- 06/04/2023
- SPC Extension Request Refusal Date:
- SPC Extension Revocation Date:
Marketing Authorization
1
- Marketing Authorization Number:
- EU/1/15/1061/002
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 23/11/2015
- Marketing Authorization Country:
- European Union (EU)
2
- Marketing Authorization Number:
- EU/1/15/1061/001
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 23/11/2015
- Marketing Authorization Country:
- European Union (EU)
Dates
- Filing date:
- 22/04/2016
- First Marketing Authorization date:
- 23/11/2015
- Grant date:
- 30/06/2016
- Activation date:
- 20/07/2021
- Lapsed By Non Payment Annual Fee Date:
- Renunciation Date:
- NullificationDate:
- Registration date:
- 04/05/2016
- SPC/SPC Extension Expiration Date:
- 19/01/2027
- Lapsed By Expiration Date:
- Withdrawal date:
- Revocation Date:
- Invalidity Date:
- Withdrawal Market Authorization Date:
- Refusal Date:
Applicant/holder
- From:
- 04/05/2016
- Name:
- GILEAD SCIENCES, INC.
- Address:
- 333 Lakeside Drive, FOSTER CITY CA 94404, United States of America (US)
Agent
1
- Name:
- ir. B.Ch. Ledeboer c.s
- From:
- 28/07/2025
- Address:
- V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
- To:
2
- Name:
- ir. H.A. Witmans c.s.
- From:
- 04/05/2016
- Address:
- V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
- To:
- 28/07/2025
Publication
Bulletin
1
- Bulletin Heading:
- SPC
- Journal edition number:
- 15/23
- Publication date:
- 12/04/2023
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
2
- Bulletin Heading:
- SPC
- Journal edition number:
- 03/23
- Publication date:
- 18/01/2023
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
3
- Bulletin Heading:
- SPC
- Journal edition number:
- 29/21
- Publication date:
- 21/07/2021
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
4
- Bulletin Heading:
- SPC
- Journal edition number:
- 27/16
- Publication date:
- 06/07/2016
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
5
- Bulletin Heading:
- SPC
- Journal edition number:
- 18/16
- Publication date:
- 04/05/2016
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
Annual Fee
- Annual Fee(s) Due Date:
- 31/07/2026
- Annual Fee Number:
- 26
- Annual Fee Amount:
- 1300 Euro
- Last Annual Payment Date:
- 01/07/2025
- Last Annual Fee Paid Number:
- 25
- Last Annual Fee Paid Amount:
- 2400 Euro
- Payer:
- Arnold & Siedsma BV
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 06/04/2023 | Certificate | Certificate | 1 | /5/5/9/2/5/0800052955/docs/300803_9_spcxcertificate20230406104904989.pdf | ||
| 06/04/2023 | Outgoing Correspondence | Decision extension duration | 1 | /5/5/9/2/5/0800052955/docs/300803_10_539984l504c.pdf | ||
| 13/01/2023 | Outgoing Correspondence | Confirmation receipt request for extension | 1 | /5/5/9/2/5/0800052955/docs/300803_8_524186l505.pdf | ||
| 04/01/2023 | Application Form | First filed application form | 3 | /5/5/9/2/5/0800052955/docs/300803_11_applicationform20230104033432408.pdf | ||
| 04/01/2023 | SPC Documents | Annex SPC | 1 | /5/5/9/2/5/0800052955/docs/300803_12_supplprotectioncertificate20230104033432481.pdf | ||
| 04/01/2023 | SPC Documents | Marketing Authorization SPC | 3 | /5/5/9/2/5/0800052955/docs/300803_13_supplprotectioncertificate20230104033432507.pdf | ||
| 04/01/2023 | SPC Documents | Annex SPC | 2 | /5/5/9/2/5/0800052955/docs/300803_14_supplprotectioncertificate20230104033432554.pdf | ||
| 04/01/2023 | SPC Documents | Annex SPC | 18 | /5/5/9/2/5/0800052955/docs/300803_15_supplprotectioncertificate20230104033432582.pdf | ||
| 04/01/2023 | SPC Documents | Summary of the characteristics of the product | 41 | /5/5/9/2/5/0800052955/docs/300803_16_supplprotectioncertificate20230104033432525.pdf | ||
| 04/01/2023 | SPC Documents | Annex SPC | 1 | /5/5/9/2/5/0800052955/docs/300803_17_supplprotectioncertificate20230104033432461.pdf | ||
| 30/06/2016 | Outgoing Correspondence | Decision grant | 1 | /5/5/9/2/5/0800052955/docs/300803_0_outgoingcorrespondence20160701045009111.pdf | ||
| 30/06/2016 | SPC Documents | Certificate SPC | 1 | /5/5/9/2/5/0800052955/docs/300803_5_supplprotectioncertificate20210106042257418.pdf | ||
| 04/05/2016 | Outgoing Correspondence | Confirmation receipt request | 1 | /5/5/9/2/5/0800052955/docs/300803_1_outgoingcorrespondence20210106041859851.pdf | ||
| 22/04/2016 | Application Form | First filed application form | 3 | /5/5/9/2/5/0800052955/docs/300803_2_applicationform20160504071628509.pdf | ||
| 22/04/2016 | SPC Documents | SPC Documents | 3 | /5/5/9/2/5/0800052955/docs/300803_3_supplprotectioncertificate20160504071629322.pdf | ||
| 22/04/2016 | SPC Documents | Annex SPC | 2 | /5/5/9/2/5/0800052955/docs/300803_4_supplprotectioncertificate20210106041651724.pdf | ||
| 22/04/2016 | SPC Documents | Summary of the characteristics of the product | 31 | /5/5/9/2/5/0800052955/docs/300803_6_supplprotectioncertificate20210106041651651.pdf | ||
| 22/04/2016 | SPC Documents | Annex SPC | 15 | /5/5/9/2/5/0800052955/docs/300803_7_supplprotectioncertificate20210106041651823.pdf |