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 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
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 |
---|---|
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
International Patents for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 6964702 | ⤷ Try a Trial | |
New Zealand | 587549 | 6-Amino-indole derivatives and processes for their preparation | ⤷ Try a Trial |
Serbia | 56037 | MODULATORI ATP-VEZUJUĆIH KASETNIH TRANSPORTERA (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS) | ⤷ Try a Trial |
China | 103254177 | Modulators of atp-binding cassette transporters | ⤷ Try a Trial |
Russian Federation | 2015153068 | ТВЕРДЫЕ ФОРМЫ (R)-1-(2, 2-ДИФТОРБЕНЗО[d][1, 3]ДИОКСОЛ-5-ИЛ)-N-(1-(2, 3-ДИГИДРОКСИПРОПИЛ)-6-ФТОР-2-(1-ГИДРОКСИ-2-МЕТИЛПРОПАН-2-ИЛ)-1H-ИНДОЛ-5-ИЛ)ЦИКЛОПРОПАНКАРБОКСАМИДА | ⤷ Try a Trial |
Japan | 2020500906 | 嚢胞性線維症膜コンダクタンス制御因子の調節物質、医薬組成物、治療方法、及び調節物質の作製プロセス | ⤷ Try a Trial |
Israel | 277491 | אפנן וסת של מוליכות טראנסממברנלית בציסטיק פיברוזיס, תכשירים פרמצבטים, שיטות טיפול, ותהליך ליצירת האפנן (Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator) | ⤷ Try a Trial |
>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 |
---|---|---|---|---|
1773816 | 122015000050 | Germany | ⤷ Try a Trial | 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 |
2826776 | 13/2021 | Austria | ⤷ Try a Trial | 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 | 2021C/517 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SYMKEVI - TEZACAFTOR/IVACAFTOR; EEN COMBINATIE VAN (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 OF EEN VANUIT FARMACEUTISCH OOGPUNT GESCHIKT ZOUT DAARVAN EN (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OF EEN VANUIT FARMACEUTISCH OOGPUNT GESCHIKT ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106 |
2826776 | CR 2021 00013 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EN KOMBINATION AF (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)CYCLOPROPANECARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG (B) ....; REG. NO/DATE: EU/1/18/1306 20181106 |
1773816 | 617 | Finland | ⤷ Try a Trial | |
2826776 | CA 2021 00013 | Denmark | ⤷ Try a Trial | 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 |
2826776 | C02826776/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TEZACAFTOR UND IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66742 10.05.2019 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |