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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

International Patents:	149
US Patents:	30
Tradenames:	3
Applicants:	2
NDAs:	5
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	71
Clinical Trials:	90
Patent Applications:	301
Drug Prices:	Drug price information for ivacaftor
DailyMed Link:	ivacaftor at DailyMed

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	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-002	Mar 17, 2015		RX	Yes	Yes			Y
Vertex Pharms	KALYDECO	ivacaftor	TABLET;ORAL	203188-001	Jan 31, 2012		RX	Yes	Yes			Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-001	Aug 7, 2018		RX	Yes	No
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes			Y

International Patents for ivacaftor

Country	Patent Number	Estimated Expiration
Japan	2017061565
Canada	2881078
Denmark	2489659
European Patent Office	3216787
Luxembourg	92761
Canada	2865519
Israel	213158

Supplementary Protection Certificates for ivacaftor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	C20150028 00162	Estonia		PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012
1773816	PA2015028	Lithuania		PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
1773816	122015000050	Germany		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		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		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		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		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