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Generated: March 23, 2019

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Ivacaftor - Generic Drug Details

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What are the generic sources for ivacaftor and what is the scope of ivacaftor patent protection?

Ivacaftor is the generic ingredient in three branded drugs marketed by Vertex Pharms Inc and Vertex Pharms, and is included in five NDAs. There are thirty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor has one hundred and forty-nine patent family members in twenty-six countries.

There are three drug master file entries for ivacaftor. One supplier is listed for this compound.

Summary for ivacaftor
Synonyms for ivacaftor
1134822-00-6
1174930-71-2
1413431-05-6
1Y740ILL1Z
3-Quinolinecarboxamide, N-(2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl)-1,4-dihydro-4-oxo-
3-Quinolinecarboxamide, N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxo-
4CA-0661
873054-44-5
A25626
AB0008116
AB01565806_02
AB2000007
ABP000259
AC-28324
AK170457
AKOS015994762
AKOS032950001
AN-16981
AOB31714
BC660099
BCP9000799
BCPP000199
BDBM50032693
CHEBI:66901
CHEMBL2010601
CS-0497
D09916
DB08820
DTXSID00236281
EX-7211
EX-A441
FT-0696681
GTPL4342
HMS3654E10
HY-13017
Ivacaftor (USAN/INN)
Ivacaftor (VX-770)
Ivacaftor [USAN:INN]
Ivacaftor D18
Ivacaftor; Kalydeco
ivacaftorum
Kalydeco
Kalydeco (TN)
Kalydeco|||N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxo-3-quinolinecarboxamide
KB-81476
KS-0000063W
LE-0002
MLS006011119
MolPort-009-194-229
N-(2,4-di-tert-butyl-5-hydroxyphenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide
N-(2,4-ditert-butyl-5-hydroxy-phenyl)-4-oxo-1H-quinoline-3-carboxamide
N-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1H-quinoline-3-carboxamide
N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
N-[2,4-Bis(tert-butyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxo-3-quinolinecarboxamide
NCGC00242480-01
PURKAOJPTOLRMP-UHFFFAOYSA-N
QCR-155
QUI135
s1144
SB16815
SC-95534
SCHEMBL351373
SMR004702900
SW219620-1
Tube715
UNII-1Y740ILL1Z
VX 770
VX-770
VX-770 - Ivacaftor
VX-770, Ivacaftor, Kalydeco
VX-770/VX770
VX770
VX770, VX 770, Ivacaftor, 873054-44-5
W-5681
X7565
ZINC52509463

US Patents and Regulatory Information for ivacaftor

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-002 Mar 17, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Vertex Pharms KALYDECO ivacaftor TABLET;ORAL 203188-001 Jan 31, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for ivacaftor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 C20150028 00162 Estonia ➤ Sign Up PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012
1773816 PA2015028 Lithuania ➤ Sign Up PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
1773816 122015000050 Germany ➤ Sign Up PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBONSAEUREAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
1773816 C300748 Netherlands ➤ Sign Up PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816 CR 2015 00038 Denmark ➤ Sign Up PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120725
1773816 35/2015 Austria ➤ Sign Up PRODUCT NAME: N-(5-HYDROXY-2,4DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001, EU/1/12/782/002 (MITTEILUNG) 20120725
1773816 237 5014-2015 Slovakia ➤ Sign Up PRODUCT NAME: N-(5-HYDROXY-2,4-DITERC-BUTYL-FENYL)-4-OXO- -1H-CHINOLIN-3-KARBOXAMID (IVACAFTOR); REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120725
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Chinese Patent Office
Moodys
Julphar
Teva
UBS

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