Volunteer for clinical trials for elexacaftor, ivacaftor, tezacaftor; ivacaftor at ClinicalTrialExchange

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Elexacaftor, ivacaftor, tezacaftor; ivacaftor - Generic Drug Details

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What are the generic drug 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 one NDA. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for elexacaftor, ivacaftor, tezacaftor; ivacaftor

International Patents:	418
US Patents:	21
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	16
DailyMed Link:	elexacaftor, ivacaftor, tezacaftor; ivacaftor at DailyMed

Recent Clinical Trials for elexacaftor, ivacaftor, tezacaftor; ivacaftor

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

Sponsor	Phase
Children's Hospital Medical Center, Cincinnati	N/A
University of Southern California	Phase 4
Teagasc	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
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes
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	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No
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	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No			Y

International Patents for elexacaftor, ivacaftor, tezacaftor; ivacaftor

Country	Patent Number	Estimated Expiration
Mexico	345541
Serbia	53895
Denmark	2489659
New Zealand	587549
European Patent Office	3708564
Russian Federation	2711481

Supplementary Protection Certificates for elexacaftor, ivacaftor, tezacaftor; ivacaftor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	300748	Netherlands		PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE (INN: IVACAFTOR) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816	C300748	Netherlands		PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816	132016000022519	Italy		PRODUCT NAME: IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KALYDECO); AUTHORISATION NUMBER(S) AND DATE(S): EU/12/782/001-002, 20120725