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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
AstraZeneca
McKinsey
Boehringer Ingelheim
Queensland Health
Harvard Business School
Express Scripts
US Department of Justice
Merck

Generated: June 22, 2018

DrugPatentWatch Database Preview

KALYDECO Drug Profile

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Which patents cover Kalydeco, 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.

This drug has one hundred and thirty-six patent family members in twenty-five countries.

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.
Summary for KALYDECO
International Patents:136
US Patents:8
Applicants:2
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 67
Clinical Trials: 19
Patent Applications: 196
DailyMed Link:KALYDECO at DailyMed
Drug patent expirations by year for KALYDECO
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 ➤ 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 Y Y ➤ 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 Y ➤ Try a Free Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-001 Mar 17, 2015 RX Yes No ➤ 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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Non-Orange Book US Patents for KALYDECO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,741,925 Modulators of ATP-binding cassette transporters ➤ Try a Free Trial
9,139,530 Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide ➤ Try a Free Trial
8,829,204 Modulators of ATP-binding cassette transporters ➤ Try a Free Trial
9,090,619 Modulators of ATP-binding cassette transporters ➤ Try a Free Trial
Patent No. Title Estimated Patent 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
2015028 Lithuania ➤ Try a Free Trial PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
00748 Netherlands ➤ Try a Free Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Fish and Richardson
Daiichi Sankyo
Healthtrust
Johnson and Johnson
Argus Health
Cerilliant
Harvard Business School
Baxter

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