Patent details
300748 Product Name: Ivacaftor, of een farmaceutisch aanvaardbaar zout daarvan
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Basic Information
- Publication number:
- 300748
- Type:
- Certificate
- SPC Type:
- Medical
- Basic Patent Number:
- EP1773816
- Status:
- SPC in force
- Application number:
- 300748
- Procedural language:
- Dutch
- First Applicant Residence Country:
Paediatric Extension
- SPC Extension Filing Date:
- 21/07/2025
- SPC Extension Agent/Owner Name:
- Vertex Pharmaceuticals Incorporated , ir. B.Ch. Ledeboer c.s
- SPC Extension Status:
- Extension Granted
- SPC Extension Grant Date:
- 28/08/2025
- SPC Extension Request Refusal Date:
- SPC Extension Revocation Date:
Marketing Authorization
- Marketing Authorization Number:
- EU/1/12/782/001-002
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 25/07/2012
- Marketing Authorization Country:
- European Union (EU)
Dates
- Filing date:
- 06/07/2015
- First Marketing Authorization date:
- 25/07/2012
- Grant date:
- 12/01/2016
- Activation date:
- 24/06/2025
- Lapsed By Non Payment Annual Fee Date:
- Renunciation Date:
- NullificationDate:
- Registration date:
- 10/11/2015
- SPC/SPC Extension Expiration Date:
- 24/01/2028
- Lapsed By Expiration Date:
- Withdrawal date:
- Revocation Date:
- Invalidity Date:
- Withdrawal Market Authorization Date:
- Refusal Date:
Applicant/holder
- From:
- 06/07/2015
- Name:
- Vertex Pharmaceuticals Incorporated
- Address:
- 50 Northern Avenue, BOSTON, MA 02210, United States of America (US)
Agent
- Name:
- ir. B.Ch. Ledeboer c.s
- From:
- 06/07/2015
- Address:
- V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
- To:
Opposition
Objection/ Appeal
- Request Number:
- 000034
- Filling Date:
- 23/02/2016
- Requestor For Appeal Name:
- Vertex Pharmaceuticals Incorporated
- Reason:
- SPC Application Rejected
- Type:
- Objection
- Status:
- Completed
- Decision:
- Accepted
- Decision Issued Date:
- 20/09/2016
- Decision Summary:
Publication
Bulletin
1
- Bulletin Heading:
- SPC
- Journal edition number:
- 36/25
- Publication date:
- 03/09/2025
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
2
- Bulletin Heading:
- SPC
- Journal edition number:
- 30/25
- Publication date:
- 28/07/2025
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
3
- Bulletin Heading:
- SPC
- Journal edition number:
- 26/25
- Publication date:
- 25/06/2025
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
4
- Bulletin Heading:
- VB2
- Journal edition number:
- 38/16
- Publication date:
- 21/09/2016
- Description:
- Requests for restoration and notices of objection, notices of appeal to Court, notices of appeal to Council of State ex NL Patent Law 1995 in respect of which a decision has been taken. Oppositon(s) decisions ex European Patent Convention
5
- Bulletin Heading:
- VB1
- Journal edition number:
- 09/16
- Publication date:
- 02/03/2016
- Description:
- Requests for restoration and notices of objection, notices of appeal to Court, notices of appeal to Council of State ex NL Patent Law 1995. Opposition(s) filed ex European Patent Convention
6
- Bulletin Heading:
- SPC
- Journal edition number:
- 02/16
- Publication date:
- 13/01/2016
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
7
- Bulletin Heading:
- SPC
- Journal edition number:
- 46/15
- Publication date:
- 11/11/2015
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
8
- Bulletin Heading:
- SPC
- Journal edition number:
- 2015/29
- Publication date:
- 15/07/2015
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
Other
- Note:
Annual Fee
- Annual Fee(s) Due Date:
- 30/06/2026
- Annual Fee Number:
- 22
- Annual Fee Amount:
- 1800 Euro
- Last Annual Payment Date:
- 29/05/2025
- Last Annual Fee Paid Number:
- 21
- Last Annual Fee Paid Amount:
- 1600 Euro
- Payer:
- Computer Packages Inc. (CPI)
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 28/08/2025 | Outgoing Correspondence | Decision extension duration | 1 | /8/4/7/0/0/0400300748/docs/300748_42_300748671651l504c.pdf | ||
| 28/08/2025 | Certificate | Certificate | 1 | /8/4/7/0/0/0400300748/docs/300748_43_spcxcertificate20250828122915119.pdf | ||
| 26/08/2025 | SPC Documents | Annex SPC | 7 | /8/4/7/0/0/0400300748/docs/300748_38_supplprotectioncertificate20250826024113567.pdf | ||
| 26/08/2025 | SPC Documents | Annex SPC | 1 | /8/4/7/0/0/0400300748/docs/300748_39_supplprotectioncertificate20250826024113582.pdf | ||
| 26/08/2025 | SPC Documents | Annex SPC | 1 | /8/4/7/0/0/0400300748/docs/300748_40_supplprotectioncertificate20250826024113575.pdf | ||
| 26/08/2025 | Incoming Correspondence Paper | Incoming Correspondence Paper | 1 | /8/4/7/0/0/0400300748/docs/300748_41_incomingcorrespondencepaper20250826024113538.pdf | ||
| 07/08/2025 | SPC Documents | Annex SPC | 2 | /8/4/7/0/0/0400300748/docs/300748_20_supplprotectioncertificate20250808012801783.pdf | ||
| 22/07/2025 | Outgoing Correspondence | Confirmation receipt request for extension | 2 | /8/4/7/0/0/0400300748/docs/300748_21_300748666054l505.pdf | ||
| 21/07/2025 | Application Form | First filed application form | 3 | /8/4/7/0/0/0400300748/docs/300748_22_applicationform20250722100528578.pdf | ||
| 21/07/2025 | SPC Documents | Annex SPC | 74 | /8/4/7/0/0/0400300748/docs/300748_23_supplprotectioncertificate20250722100528672.pdf | ||
| 21/07/2025 | SPC Documents | Annex SPC | 3 | /8/4/7/0/0/0400300748/docs/300748_24_supplprotectioncertificate20250722100528664.pdf | ||
| 21/07/2025 | SPC Documents | Annex SPC | 3 | /8/4/7/0/0/0400300748/docs/300748_25_supplprotectioncertificate20250722100528685.pdf | ||
| 21/07/2025 | SPC Documents | Annex SPC | 89 | /8/4/7/0/0/0400300748/docs/300748_26_supplprotectioncertificate20250722100528633.pdf | ||
| 21/07/2025 | SPC Documents | Marketing Authorization SPC | 3 | /8/4/7/0/0/0400300748/docs/300748_27_supplprotectioncertificate20250722100528646.pdf | ||
| 21/07/2025 | SPC Documents | Summary of the characteristics of the product | 56 | /8/4/7/0/0/0400300748/docs/300748_28_supplprotectioncertificate20250722100528655.pdf | ||
| 21/07/2025 | SPC Documents | Accompanying letter SPC | 4 | /8/4/7/0/0/0400300748/docs/300748_29_supplprotectioncertificate20250722100528618.pdf | ||
| 21/07/2025 | SPC Documents | Summary of the characteristics of the product | 62 | /8/4/7/0/0/0400300748/docs/300748_30_supplprotectioncertificate20250722102310842.pdf | ||
| 21/07/2025 | SPC Documents | Annex SPC | 3 | /8/4/7/0/0/0400300748/docs/300748_31_supplprotectioncertificate20250722102310850.pdf | ||
| 21/07/2025 | SPC Documents | Annex SPC | 85 | /8/4/7/0/0/0400300748/docs/300748_32_supplprotectioncertificate20250722102310859.pdf | ||
| 21/07/2025 | SPC Documents | Marketing Authorization SPC | 3 | /8/4/7/0/0/0400300748/docs/300748_33_supplprotectioncertificate20250722102310826.pdf | ||
| 21/07/2025 | SPC Documents | Annex SPC | 1 | /8/4/7/0/0/0400300748/docs/300748_34_supplprotectioncertificate20250722102310812.pdf | ||
| 21/07/2025 | SPC Documents | Annex SPC | 61 | /8/4/7/0/0/0400300748/docs/300748_35_supplprotectioncertificate20250722123422499.pdf | ||
| 21/07/2025 | SPC Documents | Annex SPC | 8 | /8/4/7/0/0/0400300748/docs/300748_36_supplprotectioncertificate20250722123422455.pdf | ||
| 21/07/2025 | SPC Documents | Annex SPC | 2 | /8/4/7/0/0/0400300748/docs/300748_37_supplprotectioncertificate20250722123422481.pdf | ||
| 20/09/2016 | SPC Documents | Certificate SPC | 1 | /8/4/7/0/0/0400300748/docs/300748_5_supplprotectioncertificate20160920120136645.pdf | ||
| 20/09/2016 | Appeal | Decision appeal procedure | 3 | /8/4/7/0/0/0400300748/docs/300748_6_appeal20160920113910756.pdf | ||
| 08/09/2016 | Incoming Correspondence Paper | Accompanying letter incoming document | 1 | /8/4/7/0/0/0400300748/docs/300748_14_incomingcorrespondencepaper20210319114717005.pdf | ||
| 14/07/2016 | Appeal | Subsequently filed documents appeal procedure | 3 | /8/4/7/0/0/0400300748/docs/300748_19_appeal20160714023534572.pdf | ||
| 25/05/2016 | SPC Documents | Subsequently filed documents | 3 | /8/4/7/0/0/0400300748/docs/300748_1_supplprotectioncertificate20160527072054623.pdf | ||
| 24/05/2016 | SPC Documents | Subsequently filed documents | 3 | /8/4/7/0/0/0400300748/docs/300748_2_supplprotectioncertificate20160527072053990.pdf | ||
| 12/04/2016 | Appeal | Subsequently filed documents appeal procedure | 1 | /8/4/7/0/0/0400300748/docs/300748_16_appeal20160714023831939.pdf | ||
| 24/02/2016 | Appeal | Request appeal | 2 | /8/4/7/0/0/0400300748/docs/300748_3_appeal20160229040831291.pdf | ||
| 23/02/2016 | Appeal | Request appeal | 2 | /8/4/7/0/0/0400300748/docs/300748_18_appeal20160229040942516.pdf | ||
| 14/01/2016 | Outgoing Correspondence | Decision grant | 2 | /8/4/7/0/0/0400300748/docs/300748_15_outgoingcorrespondence20201207041237689.pdf | ||
| 12/01/2016 | SPC Documents | Annex SPC | 8 | /8/4/7/0/0/0400300748/docs/300748_0_supplprotectioncertificate20201207040933425.pdf | ||
| 12/01/2016 | SPC Documents | Certificate SPC | 1 | /8/4/7/0/0/0400300748/docs/300748_13_supplprotectioncertificate20201207040601437.pdf | ||
| 09/07/2015 | Outgoing Correspondence | Outgoing Letter | 1 | /8/4/7/0/0/0400300748/docs/300748_17_outgoingcorrespondence20150709.pdf | ||
| 07/07/2015 | SPC Documents | Marketing Authorization SPC | 4 | /8/4/7/0/0/0400300748/docs/300748_4_supplprotectioncertificate20201207040300363.pdf | ||
| 07/07/2015 | SPC Documents | Annex SPC | 1 | /8/4/7/0/0/0400300748/docs/300748_7_supplprotectioncertificate20201207040113878.pdf | ||
| 07/07/2015 | Application Form | First filed application form | 3 | /8/4/7/0/0/0400300748/docs/300748_8_applicationform20150707.pdf | ||
| 07/07/2015 | SPC Documents | Accompanying letter SPC | 1 | /8/4/7/0/0/0400300748/docs/300748_9_supplprotectioncertificate20201207034745263.pdf | ||
| 07/07/2015 | SPC Documents | Annex SPC | 3 | /8/4/7/0/0/0400300748/docs/300748_10_supplprotectioncertificate20201207035855133.pdf | ||
| 07/07/2015 | SPC Documents | Summary of the characteristics of the product | 16 | /8/4/7/0/0/0400300748/docs/300748_11_supplprotectioncertificate20201207035855062.pdf | ||
| 07/07/2015 | SPC Documents | Annex SPC | 15 | /8/4/7/0/0/0400300748/docs/300748_12_supplprotectioncertificate20201207035855228.pdf |