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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 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-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor has one hundred and fifty-seven 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

International Patents:	157
US Patents:	33
Tradenames:	3
Applicants:	2
NDAs:	5
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	78
Clinical Trials:	101
Patent Applications:	338
Drug Prices:	Drug price trends for ivacaftor
DailyMed Link:	ivacaftor at DailyMed

See drug prices for ivacaftor

Recent Clinical Trials for ivacaftor

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

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
National Heart, Lung, and Blood Institute (NHLBI)	Early Phase 1
Nottingham University Hospitals Charity	Phase 2

See all ivacaftor clinical trials

Pharmacology for ivacaftor

Drug Class	Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Mechanism of Action	Chloride Channel Activation Potentiators Cytochrome P450 3A4 Inhibitors Cytochrome P450 2C9 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 3A Inhibitors

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	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-002	Mar 17, 2015		RX	Yes	Yes
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	Yes			Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	Yes			Y
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-003	Apr 29, 2019		RX	Yes	No

International Patents for ivacaftor

Country	Patent Number	Estimated Expiration
Hungary	S1500035
Japan	5409010
Hong Kong	1150602
World Intellectual Property Organization (WIPO)	2013130669
Israel	221826

Supplementary Protection Certificates for ivacaftor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	PA2015028,C1773816	Lithuania		PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
1773816	C20150028 00162	Estonia		PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012
1773816	C 2015 027	Romania		PRODUCT NAME: IVACAFTOR SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIAN-(5-HIDROXI-2,4-DITERT-BUTIL-FENIL)-4-OXO-1H-CHINOLIN-3-CARBOXAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/12/782/001, EU/1/12/782/002; DATE OF NATIONAL AUTHORISATION: 20120723; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/782/001, EU/1/12/782/002; DATE OF FIRST AUTHORISATION IN EEA: 20120723
1773816	CA 2015 00038	Denmark		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
1773816	15C0045	France		PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725