Ivacaftor; lumacaftor - Generic Drug Details

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What are the generic sources for ivacaftor; lumacaftor and what is the scope of patent protection?

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:	36
DailyMed Link:	ivacaftor; lumacaftor at DailyMed

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

Generic Entry Dates for ivacaftor; lumacaftor^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: GRANULE;ORAL
Generic Entry Dates for ivacaftor; lumacaftor^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Qanatpharma Canada LTD	Phase 1
Children's Hospital Medical Center, Cincinnati	N/A
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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-003	Sep 2, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-001	Aug 7, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-001	Aug 7, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-001	Jul 2, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for ivacaftor; lumacaftor

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ivacaftor; lumacaftor

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Country	Patent Number	Title	Estimated Expiration
South Korea	20160040745	3-(6-(1-(2,2-디플루오로벤조[ｄ][1,3]디옥솔-5-일)사이클로프로판카복스아미도)-3-메틸피리딘-2-일)벤조산의 고체 형태 (SOLID FORMS OF 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3]DIOXOL-5-YL)CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID)	⤷ Sign Up
Russian Federation	2012123372	ГЕТЕРОЦИКЛИЧЕСКИЕ МОДУЛЯТОРЫ ТРАНСПОРТЕРОВ АТФ-СВЯЗЫВАЮЩЕЙ КАССЕТЫ	⤷ Sign Up
New Zealand	602838	Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid and administration thereof	⤷ Sign Up
Hong Kong	1150602	-結合彈夾轉運蛋白的調控劑 (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS ATP-)	⤷ Sign Up
Argentina	081760	UNA COMPOSICION FARMACEUTICA PARA ADMINISTRACION ORAL QUE COMPRENDE ACIDO 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3]DIOXOL-5-IL)CICLOPROPANCARBOXAMIDO)-3-METILPIRIDIN-2-IL)BENZOICO, UN METODO PARA PRODUCIR LA MISMA, UNA TABLETA Y UNA FORMA UNITARIA DE DOSIFICACION ORAL QUE LA COMPRENDE Y EL USO DE LA MISMA PARA LA FABRICACION DE UN MEDICAMENTO	⤷ Sign Up
China	101006076	Modulators of ATP-binding cassette transporters	⤷ Sign Up
Japan	5941095		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ivacaftor; lumacaftor

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3170818	2020025	Norway	⤷ Sign Up	PRODUCT NAME: EN KOMBINASJON AV (A) 3-(6-; REG. NO/DATE: EU/1/15/1059 20151210
1773816	CA 2015 00038	Denmark	⤷ Sign Up	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
2404919	132016000049236	Italy	⤷ Sign Up	PRODUCT NAME: LUMACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, O UN SUO ESTERE PROFARMACO(ORKAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1059/001, 20151124
1773816	132016000022519	Italy	⤷ Sign Up	PRODUCT NAME: IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KALYDECO); AUTHORISATION NUMBER(S) AND DATE(S): EU/12/782/001-002, 20120725
3170818	C202030042	Spain	⤷ Sign Up	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
1773816	237 5014-2015	Slovakia	⤷ Sign Up	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
1773816	122015000050	Germany	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 verification 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.