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Last Updated: November 2, 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-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: 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 TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-003 Sep 2, 2022 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-003 Sep 2, 2022 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 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

Supplementary Protection Certificates for IVACAFTOR; LUMACAFTOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2404919 16C0020 France ⤷  Sign Up PRODUCT NAME: LUMACAFTOR, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU SES PROMEDICAMENTS ESTERS; REGISTRATION NO/DATE: EU/1/15/1059 20151124
2404919 249 5006-2016 Slovakia ⤷  Sign Up PRODUCT NAME: LUMAKAFTOR; REGISTRATION NO/DATE: EU/1/15/1059 20151124
2404919 132016000049236 Italy ⤷  Sign Up PRODUCT NAME: LUMACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, O UN SUO ESTERE PROFARMACO(ORKAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1059/001, 20151124
3170818 LUC00172 Luxembourg ⤷  Sign Up PRODUCT NAME: A COMBINATION OF (A) 3-(6-(1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID AND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/15/1059 20151124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.