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Last Updated: June 24, 2021

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ZYDELIG Drug Profile


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Which patents cover Zydelig, and what generic alternatives are available?

Zydelig is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has one hundred and sixty-nine patent family members in forty-seven countries.

The generic ingredient in ZYDELIG is idelalisib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the idelalisib profile page.

DrugPatentWatch® Generic Entry Outlook for Zydelig

Zydelig was eligible for patent challenges on July 23, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 2, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZYDELIG
Drug patent expirations by year for ZYDELIG
Drug Prices for ZYDELIG

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for ZYDELIG
Generic Entry Date for ZYDELIG*:
Constraining patent/regulatory exclusivity:
NDA:
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 ZYDELIG

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

SponsorPhase
Loxo Oncology, Inc.Phase 3
Zhonglin HaoPhase 1/Phase 2
Gilead SciencesPhase 1/Phase 2

See all ZYDELIG clinical trials

Pharmacology for ZYDELIG

US Patents and Regulatory Information for ZYDELIG

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 205858-002 Jul 23, 2014 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZYDELIG

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014   Try Before You Buy   Try Before You Buy
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014   Try Before You Buy   Try Before You Buy
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014   Try Before You Buy   Try Before You Buy
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014   Try Before You Buy   Try Before You Buy
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZYDELIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761540 C20170009 00226 Estonia   Try Before You Buy PRODUCT NAME: IDELALISIIB;REG NO/DATE: EU/1/14/938 19.09.2014
1761540 CR 2017 00007 Denmark   Try Before You Buy PRODUCT NAME: IDELALISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/938 20140919
1761540 C 2017 009 Romania   Try Before You Buy 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   Try Before You Buy PRODUCT NAME: IDELALISIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/938 20140918
1761540 132017000031007 Italy   Try Before You Buy PRODUCT NAME: IDELALISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYDELIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/938, 20140919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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