Patent details
300596 Product Name: Insuline degludec.
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Basic Information
- Publication number:
- 300596
- Type:
- Certificate
- SPC Type:
- Medical
- Basic Patent Number:
- EP2107069
- Status:
- SPC in force
- Application number:
- 300596
- Procedural language:
- Dutch
- First Applicant Residence Country:
Paediatric Extension
- SPC Extension Filing Date:
- 13/12/2016
- SPC Extension Agent/Owner Name:
- ir. M.F.J.M. Ketelaars c.s. , NOVO NORDISK A/S
- SPC Extension Status:
- Extension Granted
- SPC Extension Grant Date:
- 01/06/2017
- SPC Extension Request Refusal Date:
- SPC Extension Revocation Date:
Marketing Authorization
1
- Marketing Authorization Number:
- EU/1/12/807/001
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 23/01/2013
- Marketing Authorization Country:
- European Union (EU)
2
- Marketing Authorization Number:
- EU/1/12/807/004
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 23/01/2013
- Marketing Authorization Country:
- European Union (EU)
3
- Marketing Authorization Number:
- EU/1/12/807/005
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 23/01/2013
- Marketing Authorization Country:
- European Union (EU)
4
- Marketing Authorization Number:
- EU/1/12/807/007
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 23/01/2013
- Marketing Authorization Country:
- European Union (EU)
5
- Marketing Authorization Number:
- EU/1/12/807/008
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 23/01/2013
- Marketing Authorization Country:
- European Union (EU)
6
- Marketing Authorization Number:
- EU/1/12/807/009
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 23/01/2013
- Marketing Authorization Country:
- European Union (EU)
7
- Marketing Authorization Number:
- EU/1/12/807/012
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 23/01/2013
- Marketing Authorization Country:
- European Union (EU)
8
- Marketing Authorization Number:
- EU/1/12/807/013
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 23/01/2013
- Marketing Authorization Country:
- European Union (EU)
9
- Marketing Authorization Number:
- EU/1/12/807/015
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 23/01/2013
- Marketing Authorization Country:
- European Union (EU)
Dates
- Filing date:
- 17/06/2013
- First Marketing Authorization date:
- 23/01/2013
- Grant date:
- 01/10/2013
- Activation date:
- 22/07/2024
- Lapsed By Non Payment Annual Fee Date:
- Renunciation Date:
- NullificationDate:
- Registration date:
- 17/06/2013
- SPC/SPC Extension Expiration Date:
- 22/07/2028
- Lapsed By Expiration Date:
- Withdrawal date:
- Revocation Date:
- Invalidity Date:
- Withdrawal Market Authorization Date:
- Refusal Date:
Applicant/holder
- From:
- 17/06/2013
- Name:
- NOVO NORDISK A/S
- Address:
- Novo Allé, 2880 BAGSVÆRD, Denmark (DK)
Agent
- Name:
- ir. M.F.J.M. Ketelaars c.s.
- From:
- 17/06/2013
- Address:
- NLO Postbus 29720, 2502 LS, Den Haag, Netherlands (NL)
- To:
Publication
Bulletin
1
- Bulletin Heading:
- SPC
- Journal edition number:
- 30/24
- Publication date:
- 24/07/2024
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
2
- Bulletin Heading:
- SPC
- Journal edition number:
- 23/17
- Publication date:
- 07/06/2017
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
3
- Bulletin Heading:
- SPC
- Journal edition number:
- 51/16
- Publication date:
- 21/12/2016
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
4
- Bulletin Heading:
- SPC
- Journal edition number:
- 2013/42
- Publication date:
- 16/10/2013
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
5
- Bulletin Heading:
- SPC
- Journal edition number:
- 2013/26
- Publication date:
- 26/06/2013
- 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:
- 23
- Annual Fee Amount:
- 2000 Euro
- Last Annual Payment Date:
- 20/06/2025
- Last Annual Fee Paid Number:
- 22
- Last Annual Fee Paid Amount:
- 1800 Euro
- Payer:
- Anaqua Services
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 13/07/2017 | Outgoing Correspondence | Letter to applicant | 1 | /6/9/5/0/0/0400300596/docs/300596_0_outgoingcorrespondence20170714120942668.pdf | ||
| 13/07/2017 | SPC Documents | Certificate SPC | 1 | /6/9/5/0/0/0400300596/docs/300596_20_supplprotectioncertificate20170714120942768.pdf | ||
| 10/07/2017 | SPC Documents | Accompanying letter SPC | 1 | /6/9/5/0/0/0400300596/docs/300596_19_supplprotectioncertificate20200930052426736.pdf | ||
| 01/06/2017 | Outgoing Correspondence | Decision extension duration | 1 | /6/9/5/0/0/0400300596/docs/300596_6_outgoingcorrespondence20170602034227201.pdf | ||
| 31/01/2017 | SPC Documents | Annex SPC | 3 | /6/9/5/0/0/0400300596/docs/300596_18_supplprotectioncertificate20200930051524934.pdf | ||
| 31/01/2017 | Outgoing Correspondence | Letter to applicant | 1 | /6/9/5/0/0/0400300596/docs/300596_22_outgoingcorrespondence20170201104203988.pdf | ||
| 16/12/2016 | Outgoing Correspondence | Confirmation receipt request for extension | 1 | /6/9/5/0/0/0400300596/docs/300596_24_104000l505.pdf | ||
| 13/12/2016 | SPC Documents | Marketing Authorization SPC | 3 | /6/9/5/0/0/0400300596/docs/300596_2_supplprotectioncertificate20161214064621497.pdf | ||
| 13/12/2016 | SPC Documents | Annex SPC | 1 | /6/9/5/0/0/0400300596/docs/300596_4_supplprotectioncertificate20200930050834316.pdf | ||
| 13/12/2016 | SPC Documents | Summary of the characteristics of the product | 17 | /6/9/5/0/0/0400300596/docs/300596_8_supplprotectioncertificate20161214064621583.pdf | ||
| 13/12/2016 | SPC Documents | Annex SPC | 11 | /6/9/5/0/0/0400300596/docs/300596_9_supplprotectioncertificate20161214064621663.pdf | ||
| 13/12/2016 | Application Form | First filed application form | 3 | /6/9/5/0/0/0400300596/docs/300596_11_applicationform20161214064621261.pdf | ||
| 13/12/2016 | SPC Documents | Accompanying letter SPC | 2 | /6/9/5/0/0/0400300596/docs/300596_13_supplprotectioncertificate20200930050556547.pdf | ||
| 05/01/2016 | SPC Documents | Certificate SPC | 1 | /6/9/5/0/0/0400300596/docs/300596_14_supplprotectioncertificate20200930045424249.pdf | ||
| 05/01/2016 | Outgoing Correspondence | Outgoing Letter | 1 | /6/9/5/0/0/0400300596/docs/300596_15_outgoingcorrespondence20200930045229588.pdf | ||
| 23/11/2015 | SPC Documents | Annex SPC | 7 | /6/9/5/0/0/0400300596/docs/300596_1_supplprotectioncertificate20200930034927383.pdf | ||
| 23/11/2015 | SPC Documents | Accompanying letter SPC | 2 | /6/9/5/0/0/0400300596/docs/300596_5_supplprotectioncertificate20200930034549001.pdf | ||
| 01/10/2013 | SPC Documents | Certificate SPC | 1 | /6/9/5/0/0/0400300596/docs/300596_12_supplprotectioncertificate20200930033844452.pdf | ||
| 01/10/2013 | Outgoing Correspondence | Outgoing Letter | 1 | /6/9/5/0/0/0400300596/docs/300596_21_outgoingcorrespondence20131001.pdf | ||
| 23/09/2013 | SPC Documents | Accompanying letter SPC | 1 | /6/9/5/0/0/0400300596/docs/300596_17_supplprotectioncertificate20200930032552638.pdf | ||
| 28/08/2013 | Outgoing Correspondence | Outgoing Letter | 2 | /6/9/5/0/0/0400300596/docs/300596_7_outgoingcorrespondence20130828.pdf | ||
| 18/06/2013 | Outgoing Correspondence | Outgoing Letter | 1 | /6/9/5/0/0/0400300596/docs/300596_3_outgoingcorrespondence20130618.pdf | ||
| 17/06/2013 | SPC Documents | Marketing Authorization SPC | 4 | /6/9/5/0/0/0400300596/docs/300596_10_supplprotectioncertificate20200930032125075.pdf | ||
| 17/06/2013 | SPC Documents | Summary of the characteristics of the product | 15 | /6/9/5/0/0/0400300596/docs/300596_16_supplprotectioncertificate20200930032000637.pdf | ||
| 17/06/2013 | Application Form | First filed application form | 2 | /6/9/5/0/0/0400300596/docs/300596_23_applicationform20130617.pdf |