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
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
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 |
International Patents for IVACAFTOR; LUMACAFTOR
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2006002421 | ⤷ Sign Up | |
Hong Kong | 1161140 | ⤷ Sign Up | |
Japan | 2013501787 | ⤷ Sign Up | |
China | 102775396 | Modulators of ATP-binding cassette transporters | ⤷ 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 | 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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