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