IVACAFTOR; LUMACAFTOR - Generic Drug Details
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What are the generic sources for ivacaftor; lumacaftor and what is the scope of patent protection?
Ivacaftor; lumacaftor
is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in two NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivacaftor; lumacaftor has four hundred and fifty-eight patent family members in thirty-six countries.
One supplier is listed for this compound.
Summary for IVACAFTOR; LUMACAFTOR
International Patents: | 458 |
US Patents: | 22 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 36 |
DailyMed Link: | IVACAFTOR; LUMACAFTOR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IVACAFTOR; LUMACAFTOR
Generic Entry Dates for IVACAFTOR; LUMACAFTOR*:
Constraining patent/regulatory exclusivity:
Dosage:
GRANULE;ORAL |
Generic Entry Dates for IVACAFTOR; LUMACAFTOR*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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 IVACAFTOR; LUMACAFTOR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Qanatpharma Canada LTD | Phase 1 |
Children's Hospital Medical Center, Cincinnati | N/A |
University of North Carolina | Early Phase 1 |
Pharmacology for IVACAFTOR; LUMACAFTOR
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Vertex Pharmaceuticals (Ireland) Limited | Orkambi | lumacaftor, ivacaftor | EMEA/H/C/003954 Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene.Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. |
Authorised | no | no | no | 2015-11-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for IVACAFTOR; LUMACAFTOR
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1773816 | ⤷ Sign Up | |
European Patent Office | 1255772 | ⤷ Sign Up | |
Croatia | P20200664 | ⤷ Sign Up | |
Lithuania | 2464337 | ⤷ Sign Up | |
Israel | 275854 | קומפוזיציה פרמצטית ונתינה שלה (Pharmaceutical composition and administration thereof) | ⤷ Sign Up |
Australia | 2016216569 | ⤷ Sign Up | |
Australia | 2006332726 | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IVACAFTOR; LUMACAFTOR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2404919 | C 2016 015 | Romania | ⤷ Sign Up | PRODUCT NAME: LUMACAFTOR SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, SAU UN PROMEDICAMENT ESTER AL ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/12/1059/001-002; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/1059/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20151119 |
2404919 | 2016/018 | Ireland | ⤷ Sign Up | PRODUCT NAME: 3-(6-((1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5- YL)CYCLOPROPANECARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID (LUMACAFTOR), OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR AN ESTER PRODRUG THEREOF; REGISTRATION NO/DATE: EU/1/15/1059 20151119 |
2404919 | 17/2016 | Austria | ⤷ Sign Up | PRODUCT NAME: LUMACAFTOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN ESTER PRODRUG DAVON; REGISTRATION NO/DATE: EU/1/15/1059 (MITTEILUNG) 20151124 |
3170818 | PA2020525 | Lithuania | ⤷ Sign Up | PRODUCT NAME: (A) 3-(6-(1-(2,2-DIFLUORBENZO(D)(1,3)DIOKSOL-5-IL)CIKLOPROPANKARBOKSAMIDO)-3-METILPIRIDIN-2-IL)BENZENKARBOKSIRUGSTIES IR (B) N-(5-HIDROKSI-2,4-DITERT-BUTIL-FENIL)-4-OKSO-1H-CHINOLIN-3-KARBOKSAMIDO ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/15/1059 20151119 |
3170818 | 2020025 | Norway | ⤷ Sign Up | PRODUCT NAME: EN KOMBINASJON AV (A) 3-(6-; REG. NO/DATE: EU/1/15/1059 20151210 |
1773816 | 617 | Finland | ⤷ Sign Up | |
1773816 | 92761 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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