Elexacaftor, ivacaftor, tezacaftor; ivacaftor - Generic Drug Details

What are the generic sources for elexacaftor, ivacaftor, tezacaftor; ivacaftor and what is the scope of freedom to operate?

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

Elexacaftor, ivacaftor, tezacaftor; ivacaftor has four hundred and ninety-eight patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for elexacaftor, ivacaftor, tezacaftor; ivacaftor

International Patents:	498
US Patents:	32
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	21
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for elexacaftor, ivacaftor, tezacaftor; ivacaftor
DailyMed Link:	elexacaftor, ivacaftor, tezacaftor; ivacaftor at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for elexacaftor, ivacaftor, tezacaftor; ivacaftor

Dosage:

TABLET, TABLET;ORAL

Dosage:

GRANULES;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 elexacaftor, ivacaftor, tezacaftor; ivacaftor

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 4
Chiesi USA, Inc.	Phase 4
The Marcus Foundation, Inc.	Phase 4

See all elexacaftor, ivacaftor, tezacaftor; ivacaftor clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for elexacaftor, ivacaftor, tezacaftor; ivacaftor

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

US Patents and Regulatory Information for elexacaftor, ivacaftor, tezacaftor; 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	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No			Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No			Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No			Y	Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes			Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No			Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes			Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No

International Patents for elexacaftor, ivacaftor, tezacaftor; ivacaftor

Country	Patent Number	Title	Estimated Expiration
Singapore	10201913603Q	MODULATORS OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR
Canada	2810655	MODULATEURS DE TRANSPORTEURS DE CASSETTE DE LIAISON A L'ATP (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS)
Australia	2010249302	Modulators of ATP-Binding Cassette Transporters
European Patent Office	3812379	FORME CRYSTALLINE D'UN N-(PYRAZOL-4-YL)SULFONYL-6-(PYRAZOL-1-YL)-2-(PYRROLIDIN-1-YL)PYRIDINE-3-CARBOXAMIDE POUR TRAITER LA MUCOVISCIDOSE (CRYSTALLINE FORM OF A N-(PYRAZOL-4-YL)SULFONYL-6-(PYRAZOL-1-YL)-2-(PYRROLIDIN-1-YL)PYRIDINE-3-CARBOXAMIDE FOR TREATING CYSTIC FIBROSIS)
Japan	6964702
Australia	2023208222	Methods of treatment for cystic fibrosis
Croatia	P20170682

Supplementary Protection Certificates for elexacaftor, ivacaftor, tezacaftor; ivacaftor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2826776	13/2021	Austria		PRODUCT NAME: KOMBINATION VON (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL) CYCLOPROPANCARBOXAMID UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYLPHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID; REGISTRATION NO/DATE: EU/1/18/1306 (MITTEILUNG) 20181106
2826776	C202130026	Spain		PRODUCT NAME: UNA COMBINACION DE (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-IL)-N-(1-(2,3-DIHIDROXIPROPIL)-6-FLUORO-2-(1-HIDROXI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL)CICLOPROPANOCARBOXAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO Y(B) N-(5-HIDROXI-2,4-DITERT-BUTIL-FENIL)-4-OXO-1HQUINOLIN-3-CARBOXAMIDA O UNA SALFARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1306; DATE OF AUTHORISATION: 20181031; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1306; DATE OF FIRST AUTHORISATION IN EEA: 20181031
1773816	PA2015028	Lithuania		PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
1773816	C01773816/01	Switzerland		PRODUCT NAME: IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC 62686 13.01.2014
2826776	LUC00207	Luxembourg		PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106
1773816	C300748	Netherlands		PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816	C20150028 00162	Estonia		PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012