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Ivacaftor - Generic Drug Details
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What are the generic sources for ivacaftor and what is the scope of patent protection?
Ivacaftor
is the generic ingredient in three branded drugs marketed by Vertex Pharms Inc and Vertex Pharms, and is included in five NDAs. There are thirty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivacaftor has two hundred and forty-one patent family members in thirty-two countries.
There are three drug master file entries for ivacaftor. One supplier is listed for this compound.
Summary for ivacaftor
International Patents: | 241 |
US Patents: | 35 |
Tradenames: | 3 |
Applicants: | 2 |
NDAs: | 5 |
Drug Master File Entries: | 3 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 84 |
Clinical Trials: | 111 |
Patent Applications: | 729 |
Drug Prices: | Drug price trends for ivacaftor |
DailyMed Link: | ivacaftor at DailyMed |
Recent Clinical Trials for ivacaftor
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Sponsor | Phase |
---|---|
Children's Hospital of Fudan University | Phase 2/Phase 3 |
Istituto Auxologico Italiano | Phase 2 |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2 |
Pharmacology for ivacaftor
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 | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-002 | Jun 21, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Vertex Pharms Inc | KALYDECO | ivacaftor | GRANULE;ORAL | 207925-003 | Apr 29, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-001 | Jul 2, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-001 | Jul 2, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Vertex Pharms Inc | KALYDECO | ivacaftor | GRANULE;ORAL | 207925-001 | Mar 17, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-002 | Sep 28, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ivacaftor
Country | Patent Number | Estimated Expiration |
---|---|---|
Russian Federation | 2012109390 | Start Trial |
Russian Federation | 2014139006 | Start Trial |
China | 101891680 | Start Trial |
Japan | 5712117 | Start Trial |
New Zealand | 587551 | Start Trial |
Australia | 2016216569 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ivacaftor
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3170818 | 2020C/005 | Belgium | Start Trial | PRODUCT NAME: ORKAMBI (LUMACAFTOR + IVACAFTOR); AUTHORISATION NUMBER AND DATE: EU/1/15/1059 20151124 |
1773816 | 132016000022519 | Italy | Start Trial | PRODUCT NAME: IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KALYDECO); AUTHORISATION NUMBER(S) AND DATE(S): EU/12/782/001-002, 20120725 |
1773816 | C 2015 027 | Romania | Start Trial | PRODUCT NAME: IVACAFTOR SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIAN-(5-HIDROXI-2,4-DITERT-BUTIL-FENIL)-4-OXO-1H-CHINOLIN-3-CARBOXAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/12/782/001, EU/1/12/782/002; DATE OF NATIONAL AUTHORISATION: 20120723; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/782/001, EU/1/12/782/002; DATE OF FIRST AUTHORISATION IN EEA: 20120723 |
1773816 | CR 2015 00038 | Denmark | Start Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120725 |
1773816 | 300748 | Netherlands | Start Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE (INN: IVACAFTOR) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
1773816 | 15C0045 | France | Start Trial | PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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