ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - Generic Drug Details
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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-nine patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
International Patents: | 499 |
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
Generic Entry Dates for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, TABLET;ORAL |
Generic Entry Dates for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR*:
Constraining patent/regulatory exclusivity:
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 |
---|---|
Chiesi USA, Inc. | Phase 4 |
University of North Carolina, Chapel Hill | 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 | 212273-001 | Oct 21, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Vertex Pharms Inc | TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | GRANULES;ORAL | 217660-001 | Apr 26, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Vertex Pharms Inc | TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | GRANULES;ORAL | 217660-002 | Apr 26, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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 |
International Patents for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 365890 | MODULADORES DE TRANSPORTADORES CON CASETE DE UNIÓN CON ATP. (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS.) | ⤷ Sign Up |
Cyprus | 1123901 | ⤷ Sign Up | |
European Patent Office | 4159717 | MODULATEURS DE RÉGULATEUR DE CONDUCTANCE TRANSMEMBRANAIRE DE LA FIBROSE KYSTIQUE (MODULATORS OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2826776 | 13/2021 | Austria | ⤷ Sign Up | 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 |
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 |
1773816 | PA2015028,C1773816 | Lithuania | ⤷ Sign Up | PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |