Patent details
301105 Product Name: Een combinatie van (a) (R)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluor-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropaancarboxamide of een farmaceutisch aanvaardbaar zout daarvan en (b) N-(5-hydroxy-2,4-ditert-butyl-fenyl)-4-oxo-1H-chinoline-3-carboxamide of een farmaceutisch aanvaardbaar zout daarvan.
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Basic Information
- Publication number:
- 301105
- Type:
- Certificate
- SPC Type:
- Medical
- Basic Patent Number:
- EP2826776
- Status:
- Withdrawn
- Application number:
- 301105
- Procedural language:
- Dutch
- First Applicant Residence Country:
- United States of America (US)
Marketing Authorization
- Marketing Authorization Number:
- EU/1/18/1306
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 06/11/2018
- Marketing Authorization Country:
- European Union (EU)
Dates
- Filing date:
- 21/05/2021
- First Marketing Authorization date:
- 06/11/2018
- Grant date:
- Activation date:
- Lapsed By Non Payment Annual Fee Date:
- Renunciation Date:
- NullificationDate:
- Registration date:
- 25/05/2021
- SPC/SPC Extension Expiration Date:
- Lapsed By Expiration Date:
- Withdrawal date:
- 03/10/2025
- Revocation Date:
- Invalidity Date:
- Withdrawal Market Authorization Date:
- Refusal Date:
Applicant/holder
- From:
- 21/05/2021
- Name:
- Vertex Pharmaceuticals Incorporated
- Address:
- 50 Northern Avenue, BOSTON, MA 02210, United States of America (US)
Agent
1
- Name:
- ir. B.Ch. Ledeboer c.s
- From:
- 09/01/2025
- Address:
- V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
- To:
2
- Name:
- ir. H.A. Witmans c.s.
- From:
- 21/05/2021
- Address:
- V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
- To:
- 09/01/2025
Publication
Bulletin
1
- Bulletin Heading:
- VRV
- Journal edition number:
- 41/25
- Publication date:
- 08/10/2025
- Description:
- Lapse or annulment
2
- Bulletin Heading:
- SPC
- Journal edition number:
- 21/21
- Publication date:
- 26/05/2021
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 06/10/2025 | Outgoing Correspondence | Letter confirmation withdrawal | 1 | /4/2/6/6/8/0800686624/docs/301105_18_301105676949l193.pdf | ||
| 03/10/2025 | Incoming Correspondence Electronic | Withdrawal application | 1 | /4/2/6/6/8/0800686624/docs/301105_17_incomingcorrespondenceelectronic20251006022039372.pdf | ||
| 14/08/2025 | Outgoing Correspondence | Letter to applicant | 1 | /4/2/6/6/8/0800686624/docs/301105_14_301105669668l173.pdf | ||
| 24/06/2025 | Incoming Correspondence Electronic | Accompanying letter incoming document | 8 | /4/2/6/6/8/0800686624/docs/301105_15_incomingcorrespondenceelectronic20250624044821504.pdf | ||
| 24/06/2025 | SPC Documents | Annex SPC | 165 | /4/2/6/6/8/0800686624/docs/301105_16_supplprotectioncertificate20250624044821532.pdf | ||
| 24/03/2025 | Outgoing Correspondence | Letter to applicant | 1 | /4/2/6/6/8/0800686624/docs/301105_13_649115l173.pdf | ||
| 19/03/2025 | Incoming Correspondence Paper | Request extension time-limit modifications | 1 | /4/2/6/6/8/0800686624/docs/301105_11_incomingcorrespondencepaper20250320020027164.pdf | ||
| 24/12/2024 | Outgoing Correspondence | Letter to applicant | 3 | /4/2/6/6/8/0800686624/docs/301105_12_637177l173.pdf | ||
| 12/08/2024 | Outgoing Correspondence | Letter to applicant | 1 | /4/2/6/6/8/0800686624/docs/301105_10_616997l173.pdf | ||
| 09/08/2024 | SPC Documents | Accompanying letter SPC | 1 | /4/2/6/6/8/0800686624/docs/301105_9_supplprotectioncertificate20240812105623067.pdf | ||
| 25/05/2021 | Outgoing Correspondence | Confirmation receipt request | 1 | /4/2/6/6/8/0800686624/docs/301105_1_413388l174.pdf | ||
| 25/05/2021 | SPC Documents | SPC Documents | 3 | /4/2/6/6/8/0800686624/docs/301105_8_supplprotectioncertificate20210525031058644.pdf | ||
| 21/05/2021 | SPC Documents | Marketing Authorization SPC | 3 | /4/2/6/6/8/0800686624/docs/301105_0_supplprotectioncertificate20210521051444637.pdf | ||
| 21/05/2021 | SPC Documents | Annex SPC | 1 | /4/2/6/6/8/0800686624/docs/301105_2_supplprotectioncertificate20210521051444993.pdf | ||
| 21/05/2021 | SPC Documents | Annex SPC | 14 | /4/2/6/6/8/0800686624/docs/301105_3_supplprotectioncertificate20210521051444840.pdf | ||
| 21/05/2021 | SPC Documents | Annex SPC | 68 | /4/2/6/6/8/0800686624/docs/301105_4_supplprotectioncertificate20210521051444901.pdf | ||
| 21/05/2021 | SPC Documents | Annex SPC | 2 | /4/2/6/6/8/0800686624/docs/301105_5_supplprotectioncertificate20210521051444776.pdf | ||
| 21/05/2021 | SPC Documents | Summary of the characteristics of the product | 22 | /4/2/6/6/8/0800686624/docs/301105_6_supplprotectioncertificate20210521051444703.pdf | ||
| 21/05/2021 | SPC Documents | Accompanying letter SPC | 2 | /4/2/6/6/8/0800686624/docs/301105_7_supplprotectioncertificate20210521051444566.pdf |