Patent details

300812 Product Name: Lumacaftor 3-{6-{[1-(2,2-difluor-1,3-benzodioxol-5-yl)cyclopropaancarbonyl]amino}-3-methylpyridin-2-yl}benzoëzuur, of een farmaceutisch aanvaardbaar zout daarvan.

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Basic Information

Publication number:
300812
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP2395002
Status:
SPC granted but not yet in force
Application number:
300812
Procedural language:
Dutch
First Applicant Residence Country:
United States of America (US)

Marketing Authorization

Marketing Authorization Number:
EU/1/15/1059
Marketing Authorization Type:
EEA
Marketing Authorization Date:
24/11/2015
Marketing Authorization Country:
European Union (EU)

Dates

Filing date:
18/05/2016
First Marketing Authorization date:
24/11/2015
Grant date:
26/09/2016
Activation date:
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
25/05/2016
SPC/SPC Extension Expiration Date:
23/11/2030
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:

Applicant/holder

From:
25/05/2016
 
 

 

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:
25/05/2016
Address:
V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
To:

Publication

Bulletin

1

Bulletin Heading:
SPC
Journal edition number:
39/16
Publication date:
28/09/2016
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

2

Bulletin Heading:
SPC
Journal edition number:
21/16
Publication date:
25/05/2016
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

Annual Fee

Annual Fee(s) Due Date:
30/11/2026
Annual Fee Number:
21
Annual Fee Amount:
1600 Euro
Last Annual Payment Date:
Last Annual Fee Paid Number:
Payer:
Filing date Document type Document Description Number of pages File Type
26/09/2016 Outgoing Correspondence Decision grant 1 PDF /4/4/7/8/5/0800058744/docs/300812_0_outgoingcorrespondence20160927103040866.pdf
26/09/2016 SPC Documents Certificate SPC 1 PDF /4/4/7/8/5/0800058744/docs/300812_3_supplprotectioncertificate20160927103040948.pdf
20/09/2016 SPC Documents Accompanying letter SPC 1 PDF /4/4/7/8/5/0800058744/docs/300812_2_supplprotectioncertificate20210105055956001.pdf
27/07/2016 Outgoing Correspondence Letter to applicant 3 PDF /4/4/7/8/5/0800058744/docs/300812_8_outgoingcorrespondence20210106033140794.pdf
27/07/2016 SPC Documents Annex SPC 1 PDF /4/4/7/8/5/0800058744/docs/300812_10_supplprotectioncertificate20210106033140884.pdf
31/05/2016 Outgoing Correspondence Outgoing Letter 1 PDF /4/4/7/8/5/0800058744/docs/300812_7_59463l174.pdf
19/05/2016 SPC Documents Marketing Authorization SPC 3 PDF /4/4/7/8/5/0800058744/docs/300812_1_supplprotectioncertificate20160524123831126.pdf
19/05/2016 SPC Documents Annex SPC 2 PDF /4/4/7/8/5/0800058744/docs/300812_4_supplprotectioncertificate20210105055405375.pdf
19/05/2016 SPC Documents Annex SPC 15 PDF /4/4/7/8/5/0800058744/docs/300812_5_supplprotectioncertificate20210105055405449.pdf
19/05/2016 Application Form First filed application form 3 PDF /4/4/7/8/5/0800058744/docs/300812_6_applicationform20160524123830835.pdf
19/05/2016 SPC Documents Summary of the characteristics of the product 23 PDF /4/4/7/8/5/0800058744/docs/300812_9_supplprotectioncertificate20210105055405283.pdf