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-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivacaftor; lumacaftor has four hundred and fifty-six patent family members in thirty-five countries.
One supplier is listed for this compound.
Summary for IVACAFTOR; LUMACAFTOR
International Patents: | 456 |
US Patents: | 21 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 35 |
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 |
---|---|
Children's Hospital Medical Center, Cincinnati | N/A |
University of Miami | Early Phase 1 |
University of Kansas Medical Center | 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 |
---|---|---|---|
European Patent Office | 3219705 | COMPOSITIONS PHARMACEUTIQUES DE LA FORME AMORPHE DE N- [2,4-BIS (1,1-DIMÉTHYLÉTHYL) -5-HYDROXYPHÉNYL] -1,4-DIHYDRO-4-OXOQUINOLINE-3-CARBOXAMIDE (PHARMACEUTICAL COMPOSITIONS OF THE AMORPHOUS FORM OF N-[2,4-BIS(1,1-DIMETHYLETHYL)-5-HYDROXYPHENYL]-1,4-DIHYDRO-4-OXOQUINOLINE-3-CARBOXAMIDE) | ⤷ Try a Trial |
Portugal | 2328618 | ⤷ Try a Trial | |
Australia | 2005258320 | Modulators of ATP-Binding Cassette transporters | ⤷ Try a Trial |
China | 107501099 | ATP‑结合弹夹转运蛋白的调控剂 (Modulators of atp-binding cassette transporters) | ⤷ Try a Trial |
Lithuania | PA2015028 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IVACAFTOR; LUMACAFTOR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3170818 | 2020C/005 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ORKAMBI (LUMACAFTOR + IVACAFTOR); AUTHORISATION NUMBER AND DATE: EU/1/15/1059 20151124 |
2404919 | 93073 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ACIDE BENZOIQUE 3-{6-{-1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5-YL)CYCLOPROPANECARBONYL AMINO}-3-METHYLPYRIDIN-2-YL}, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN PRO-MEDICAMENT DE TYPE ESTER DE CELUI-CI; FIRST REGISTRATION DATE: 20151124 |
1773816 | 1590036-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/12/782/001 20120725 |
3170818 | 35/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: EINE KOMBINATION VON (A) 3-(6-(1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)CYCLOPROPANCARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOESAEURE UND (B) N-(5-HYDROXY-2,4-DITERT-BUTYLPHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1059 20151124 |
1773816 | 237 5014-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERC-BUTYL-FENYL)-4-OXO- -1H-CHINOLIN-3-KARBOXAMID (IVACAFTOR); REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120725 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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