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Last Updated: February 27, 2021

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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
Recent Clinical Trials for idelalisib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ADC Therapeutics S.A.Phase 2
Loxo Oncology, Inc.Phase 3
Fondazione Italiana Linfomi ONLUSPhase 2

See all idelalisib clinical trials

Pharmacology for idelalisib

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

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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Serving leading biopharmaceutical companies globally:

McKesson
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Harvard Business School
Medtronic

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