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Last Updated: November 23, 2024

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

SponsorPhase
Qanatpharma Canada LTDPhase 1
Children's Hospital Medical Center, CincinnatiN/A
University of North CarolinaEarly Phase 1

See all IVACAFTOR; LUMACAFTOR clinical trials

US Patents and Regulatory Information for IVACAFTOR; LUMACAFTOR

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 ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 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

EU/EMA Drug Approvals 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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