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Generated: October 18, 2018

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KALYDECO Drug Profile

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When do Kalydeco patents expire, and what generic alternatives are available?

Kalydeco is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. There are eight patents protecting this drug.

The generic ingredient in KALYDECO is ivacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor profile page.

Drug patent expirations by year for KALYDECO
Generic Entry Opportunity Date for KALYDECO
Generic Entry Dates for KALYDECO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE;ORAL
Generic Entry Dates for KALYDECO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for KALYDECO
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
D0W7WC
DB08820
DTXSID00236281
EX-7211
EX-A441
FT-0696681
GTPL4342
HE066376
HE399755
HMS3654E10
HY-13017
Ivacaftor
Ivacaftor (USAN/INN)
Ivacaftor (VX-770)
Ivacaftor [USAN:INN]
Ivacaftor-d18
ivacaftorum
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
MFCD17171361
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
SC-95534
SCHEMBL351373
SMR004702900
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 KALYDECO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertex Pharms KALYDECO ivacaftor TABLET;ORAL 203188-001 Jan 31, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-002 Mar 17, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Vertex Pharms KALYDECO ivacaftor TABLET;ORAL 203188-001 Jan 31, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-002 Mar 17, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 KALYDECO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
15/036 Ireland ➤ Try a Free Trial PRODUCT NAME: N-(5-HYDROXYL-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
7 5014-2015 Slovakia ➤ Try a Free Trial 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
2015 00038 Denmark ➤ Try a Free Trial PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723
2015028,C1773816 Lithuania ➤ Try a Free Trial PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Argus Health
Chinese Patent Office
Harvard Business School
Fuji
Farmers Insurance
McKesson
Julphar
Mallinckrodt

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