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-four patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for elexacaftor, ivacaftor, tezacaftor; ivacaftor

International Patents:	494
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
Emory University	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	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes			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	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes			Y

International Patents for elexacaftor, ivacaftor, tezacaftor; ivacaftor

Country	Patent Number	Title	Estimated Expiration
Cyprus	1116116
Denmark	1993360
Norway	2328618
Hong Kong	1209318	-二氟苯 二惡茂- -基 -二羥基 -氟代- -羥基- -甲基丙烷- -基 氫-吲哚- -基 環丙烷甲酰胺的藥劑學組合物和其應用 (PHARMACEUTICAL COMPOSITIONS OF (R)-1-(2,2- DIFLURORBENZO[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 AND ADMINISTRATION THEREOF (R)-1-(22-[D][13]-5-)-N-(1-(23-)-6--2- (1--2--2-)-1 --5-))
Cyprus	1123736

Supplementary Protection Certificates for elexacaftor, ivacaftor, tezacaftor; ivacaftor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	PA2015028,C1773816	Lithuania		PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
1773816	617	Finland
1773816	92761	Luxembourg		PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725
2826776	122021000025	Germany		PRODUCT NAME: EINE 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 ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1306 20181031
2826776	CA 2021 00013	Denmark		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) ....; REG. NO/DATE: EU/1/18/1306 20181106