Ivacaftor; lumacaftor - Generic Drug Details

What are the generic drug sources for ivacaftor; lumacaftor and what is the scope of freedom to operate?

Ivacaftor; lumacaftor is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in two NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; lumacaftor has four hundred and fifty-six patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for ivacaftor; lumacaftor

International Patents:	456
US Patents:	21
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	35
DailyMed Link:	ivacaftor; lumacaftor at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ivacaftor; lumacaftor

Dosage:

GRANULE;ORAL

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 ivacaftor; lumacaftor

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

Sponsor	Phase
Children's Hospital Medical Center, Cincinnati	N/A
University of North Carolina	Early Phase 1
University of Miami	Early Phase 1

See all ivacaftor; lumacaftor clinical trials

Pharmacology for ivacaftor; lumacaftor

Drug Class	Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Mechanism of Action	Chloride Channel Activation Potentiators Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inducers Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A Inhibitors P-Glycoprotein Inducers P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ivacaftor; lumacaftor

R07AX	Other respiratory system products
R07A	OTHER RESPIRATORY SYSTEM PRODUCTS
R07	OTHER RESPIRATORY SYSTEM PRODUCTS
R	Respiratory system

R07AX	Other respiratory system products
R07A	OTHER RESPIRATORY SYSTEM PRODUCTS
R07	OTHER RESPIRATORY SYSTEM PRODUCTS
R	Respiratory system

US Patents and Regulatory Information for ivacaftor; lumacaftor

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	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No			Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-001	Aug 7, 2018		RX	Yes	No			Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-001	Jul 2, 2015		RX	Yes	Yes			Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No			Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for ivacaftor; lumacaftor

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Vertex Pharmaceuticals (Ireland) Limited	Orkambi	lumacaftor, ivacaftor	EMEA/H/C/003954 Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene.Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene.	Authorised	no	no	no	2015-11-19

International Patents for ivacaftor; lumacaftor

Country	Patent Number	Title	Estimated Expiration
Australia	2005258320	Modulators of ATP-Binding Cassette transporters
San Marino	T201600174	FORME SOLIDE DI ACIDO 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3]DIOSSOL-5-IL)CICLOPROPANCARBOSSAMMIDO)-3-METILPIRIDIN-2-IL)BENZOICO
Serbia	61408	FARMACEUTSKA KOMPOZICIJA I NJENO ORDINIRANJE (PHARMACEUTICAL COMPOSITION AND ADMINISTRATIONS THEREOF)
China	101356170	Heterocyclic modulators of ATP-binding cassette transporters
Mexico	2012011656	COMPOSICIONES FARMACEUTICAS DE ACIDO 3-(6-(1-(2,2-DIFLUOROBENZO [D][1,3]DIOXOL-5-IL)CICLOPROPANCARBOXAMIDO)-3-METILPIRIDIN-2-IL) BENZOICO Y SU ADMINISTRACION. (PHARMACEUTICAL COMPOSITIONS OF 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIODIN-2-YL)BENZO IC ACID AND ADMINISTRATION THEREOF.)
Japan	5669319
Israel	273332	מאפננים של הובלת קסטות מקושרות atp (אדנוסין טריפוספאט) ותכשירי רוקחות המכילים אותם (Modulators of atp-binding cassette transporters and pharmaceutical compositions containing the same)

Supplementary Protection Certificates for ivacaftor; lumacaftor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3170818	C202030042	Spain		PRODUCT NAME: UNA COMBINACION DE A) LUMACAFTOR Y B) IVACAFTOR; NATIONAL AUTHORISATION NUMBER: EU/1/15/1059; DATE OF AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1059; DATE OF FIRST AUTHORISATION IN EEA: 20151119
2404919	17/2016	Austria		PRODUCT NAME: LUMACAFTOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN ESTER PRODRUG DAVON; REGISTRATION NO/DATE: EU/1/15/1059 (MITTEILUNG) 20151124
3170818	C20200025 00350	Estonia		PRODUCT NAME: LUMAKAFTOOR/IVAKAFTOOR;REG NO/DATE: EU/1/15/1059 24.11.2015
3170818	132020000000103	Italy		PRODUCT NAME: UNA COMBINAZIONE DI (A) LUMACAFTOR E (B) IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ORKAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1059, 20151124
3170818	2090033-8	Sweden		PRODUCT NAME: A COMBINATION OF (A) 3-(6-(1-(2,2-DIFLUOROBENZOD1,3DIOXOL-5-YL)CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID AND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1059 20151124
1773816	617	Finland
1773816	C300748	Netherlands		PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725