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Idelalisib - Generic Drug Details
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What are the generic sources for idelalisib and what is the scope of patent protection?
Idelalisib
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Idelalisib has one hundred and sixty-eight patent family members in forty-seven countries.
There are two drug master file entries for idelalisib. One supplier is listed for this compound.
Summary for idelalisib
International Patents: | 168 |
US Patents: | 13 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 87 |
Clinical Trials: | 58 |
Patent Applications: | 1,051 |
Formulation / Manufacturing: | see details |
DailyMed Link: | idelalisib at DailyMed |
Recent Clinical Trials for idelalisib
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Sponsor | Phase |
---|---|
ADC Therapeutics S.A. | Phase 2 |
Loxo Oncology, Inc. | Phase 3 |
Fondazione Italiana Linfomi ONLUS | Phase 2 |
Pharmacology for idelalisib
Drug Class | Kinase Inhibitor |
Mechanism of Action | Kinase Inhibitors Cytochrome P450 3A Inhibitors |
US Patents and Regulatory Information for idelalisib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | RX | Yes | No | Start Trial | Start Trial | 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 idelalisib
Country | Patent Number | Estimated Expiration |
---|---|---|
Israel | 231360 | Start Trial |
Croatia | P20161657 | Start Trial |
Australia | 2018247326 | Start Trial |
European Patent Office | 2612862 | Start Trial |
Japan | 2007537291 | Start Trial |
China | 102271683 | Start Trial |
Denmark | 2612862 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for idelalisib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1761540 | C 2017 009 | Romania | Start Trial | PRODUCT NAME: IDELALISIB SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/938; DATE OF NATIONAL AUTHORISATION: 20140918; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/938; DATE OF FIRST AUTHORISATION IN EEA: 20140918 |
1761540 | PA2017004,C1761540 | Lithuania | Start Trial | PRODUCT NAME: IDELALISIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/938 20140918 |
1761540 | CR 2017 00007 | Denmark | Start Trial | PRODUCT NAME: IDELALISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/938 20140919 |
1761540 | C20170009 00226 | Estonia | Start Trial | PRODUCT NAME: IDELALISIIB;REG NO/DATE: EU/1/14/938 19.09.2014 |
1761540 | 132017000031007 | Italy | Start Trial | PRODUCT NAME: IDELALISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYDELIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/938, 20140919 |
1761540 | 1790006-9 | Sweden | Start Trial | PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/938 20140919 |
1761540 | 122017000008 | Germany | Start Trial | PRODUCT NAME: LDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 20140918 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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