ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - Generic Drug Details

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

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

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	Y
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

International Patents for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

Country	Patent Number	Title	Estimated Expiration
Portugal	3219705
World Intellectual Property Organization (WIPO)	2019152940
Hungary	E032813

Supplementary Protection Certificates for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	PA2015028	Lithuania		PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
2826776	PA2021508	Lithuania		PRODUCT NAME: (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOKSOL-5-IL)-N-(1-(2,3-DIHIDROKSIPROPIL)-6-FLUOR-2-(1-HIDROKSI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL) CIKLOPROPANKARBOKSAMIDO ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS IR (B) N-(5-HIDROKSI-2,4-DITERT-BUTIL-FENIL)-4-OKSO-1H-CHINOLIN-3-KARBOKSAMIDO ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/18/1306 20181031
2826776	C20210011 00330	Estonia		PRODUCT NAME: TESAKAFTOOR/IVAKAFTOOR;REG NO/DATE: EU/1/18/1306 06.11.2018