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Last Updated: January 28, 2020

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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 nine patents protecting this drug.

This drug has one hundred and fifty-nine patent family members in twenty-six 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.

US ANDA Litigation and Generic Entry Outlook for Kalydeco

Kalydeco was eligible for patent challenges on January 31, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 20, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for KALYDECO
Drug patent expirations by year for KALYDECO
Drug Prices for KALYDECO

See drug prices 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.

Recent Clinical Trials for KALYDECO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
University of Alabama at BirminghamEarly Phase 1
National Heart, Lung, and Blood Institute (NHLBI)Early Phase 1

See all KALYDECO clinical trials

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
DB08820
DTXSID00236281
EX-7211
EX-A441
FT-0696681
GTPL4342
HMS3654E10
HY-13017
Ivacaftor
Ivacaftor (USAN/INN)
Ivacaftor (VX-770)
Ivacaftor [USAN:INN]
Ivacaftor D18
Ivacaftor; Kalydeco
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
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 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 203188-002 May 20, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-001 Mar 17, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Vertex Pharms KALYDECO ivacaftor TABLET;ORAL 203188-001 Jan 31, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-002 Mar 17, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-002 Mar 17, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for KALYDECO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 1590036-8 Sweden   Start Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/12/782/001 20120725
1773816 PA2015028 Lithuania   Start Trial PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
1773816 35/2015 Austria   Start Trial 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 15C0045 France   Start Trial PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816 CA 2015 00038 Denmark   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Merck
AstraZeneca
Dow
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.