Patent details
92381 Product Name: Macitentan et ses dérivés pharmaceutiquement acceptables
Basic Information
- Publication number:
- 92381
- Type:
- SPC
- SPC Type:
- Medical
- Basic Patent Number:
- EP019895705
- Legal Status:
- Active
- Application number:
- 92381
- First applicant's nationality:
- Procedural language:
- French
Paediatric Extension
- SPC Extension Filing Date:
- 22/11/2024
- SPC Extension Agent Name:
- OFFICE FREYLINGER S.A.
- SPC Extension Status:
- Granted
- SPC Extension Grant Date:
- 24/11/2025
- SPC Extension Rejection Date:
Marketing Authorization
- Marketing Authorization Number:
- EU/1/13/893 - OPSUMIT - macitentan
- Marketing Authorization Type:
- Marketing Authorization Date:
- 20/12/2013
- Marketing Authorization Status:
- Accepted
- Marketing Authorization Country:
Dates
- Filing date:
- 26/02/2014
- First Marketing Authorization date:
- 20/12/2013
- Grant date:
- 28/04/2014
- Activation date:
- 04/12/2021
- Publication date:
- 28/04/2014
- Lapsed date:
- Expiration date:
- Renunciation date:
- Revocation date:
- Annulment date:
- Basic SPC Expiration:
- 04/12/2026
- SPC Extension Expiration:
- 04/06/2027
- Rejection date:
- Withdrawal date:
Owner
- From:
- 26/02/2014
- Name:
- Actelion Pharmaceuticals Ltd.
- Address:
- Gewerbestrasse 16, 4123 Allschwil, Switzerland (CH)
Agent
- Name:
- OFFICE FREYLINGER S.A.
- From:
- 26/02/2014
- Address:
- Boîte Postale 48, L-8001, STRASSEN, Luxembourg (LU)
- To:
Inventor
1
- Name:
- BOSS Christoph
- Address:
- Switzerland (CH)
2
- Name:
- FISCHLI Walter
- Address:
- Switzerland (CH)
3
- Name:
- CLOZEL Martine
- Address:
- France (FR)
4
- Name:
- BOLLI Martin
- Address:
- Switzerland (CH)
5
- Name:
- WELLER Thomas
- Address:
- Switzerland (CH)
Publication
Bulletin
1
- Bulletin Heading:
- SPCX1
- Bulletin edition number:
- 2024/14
- Publication date:
- 06/12/2024
- Description:
- Section G : Applications for extensions for pediatric use – I1E publication
2
- Bulletin Heading:
- SPC3
- Bulletin edition number:
- 2025/04
- Publication date:
- 04/03/2025
- Description:
- Section E : Supplementary Protection certificates entered into force – IA publication
3
- Bulletin Heading:
- SPCX2
- Bulletin edition number:
- 2025/13
- Publication date:
- 04/12/2025
- Description:
- Section H : Granted extensions for pediatric use of supplementary protection certificates – I2E publication
Annual Fees
- Annual Fee Due Date:
- Annual Fee Number:
- Expected Payer:
- Last Annual Fee Payment Date:
- 28/11/2025
- Last Annual Fee Paid Number:
- 25
- Last Annual Fee Paid Amount:
- 450 Euro
- Payer:
- CPA GLOBAL THE IP PLATFORM
| Filing date | Document type | Number of pages |
|---|---|---|
| 22/11/2024 | Application Form | 3 |
| 22/11/2024 | Paediatric investigation plan | 1 |
| 22/11/2024 | Outgoing Correspondence | 1 |
| 22/11/2024 | General Document | 2 |
| 22/11/2024 | Marketing authorization | 3 |
| 22/11/2024 | Summary of the product caracteristics | 64 |
| 22/11/2024 | Publication | 1 |
| 24/11/2025 | Publication | 1 |
| 24/11/2025 | Certificate | 1 |
| 22/11/2024 | FNET_DC_FRONTPAGE | 1 |
| 24/11/2025 | Outgoing Correspondence | 1 |