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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 four NDAs. There are twenty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are three drug master file entries for ivacaftor. One supplier is listed for this compound.

Summary for ivacaftor

International Patents:	136
US Patents:	26
Tradenames:	3
Applicants:	2
NDAs:	4
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	67
Clinical Trials:	71
Patent Applications:	279
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

D0W7WC

DB08820

DTXSID00236281

EX-7211

EX-A441

FT-0696681

GTPL4342

HE066376

HE399755

HMS3654E10

HY-13017

Ivacaftor (USAN/INN)

Ivacaftor (VX-770)

Ivacaftor [USAN:INN]

Ivacaftor-d18

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

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 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	KALYDECO	ivacaftor	GRANULE;ORAL	207925-001	Mar 17, 2015		RX	Yes	No			Y	Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-001	Jul 2, 2015		RX	Yes	Yes			Y
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-002	Mar 17, 2015		RX	Yes	Yes			Y	Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-001	Jul 2, 2015		RX	Yes	Yes

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Non-Orange Book US Patents for ivacaftor

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
2,014,187,770
8,101,767	Modulators of ATP-binding cassette transporters
8,614,327	Modulators of ATP-binding cassette transporters
8,741,925	Modulators of ATP-binding cassette transporters

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International Patents for ivacaftor

Country	Document Number	Estimated Expiration
Russian Federation	2009142030
South Africa	200700601
Japan	5762940
Canada	2881078

Supplementary Protection Certificates for ivacaftor

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0748	Netherlands		PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE (INN: IVACAFTOR) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
C0045	France		PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
00748	Netherlands		PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
2015028	Lithuania		PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723