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Last Updated: November 22, 2024

IDELALISIB - Generic Drug Details


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What are the generic drug sources for idelalisib and what is the scope of freedom to operate?

Idelalisib is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Idelalisib has one hundred and eleven patent family members in forty countries.

There are two drug master file entries for idelalisib. One supplier is listed for this compound.

Summary for IDELALISIB
International Patents:111
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 106
Clinical Trials: 61
Patent Applications: 2,356
What excipients (inactive ingredients) are in IDELALISIB?IDELALISIB excipients list
DailyMed Link:IDELALISIB at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IDELALISIB
Generic Entry Date for IDELALISIB*:
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 IDELALISIB

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

SponsorPhase
Oslo University HospitalPhase 2
ADC Therapeutics S.A.Phase 2
Loxo Oncology, Inc.Phase 3

See all IDELALISIB clinical trials

Pharmacology for IDELALISIB
Paragraph IV (Patent) Challenges for IDELALISIB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZYDELIG Tablets idelalisib 100 mg and 150 mg 205858 1 2022-03-23

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 205858-002 Jul 23, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 IDELALISIB

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

EU/EMA Drug Approvals for IDELALISIB

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences Ireland UC Zydelig idelalisib EMEA/H/C/003843
Zydelig is indicated in combination with an anti‑CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
Authorised no no no 2014-09-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for IDELALISIB

Country Patent Number Title Estimated Expiration
Australia 2018247326 Therapies for hematologic malignancies ⤷  Sign Up
Japan 2012508775 ⤷  Sign Up
Cyprus 1118493 ⤷  Sign Up
Hungary E030839 ⤷  Sign Up
Eurasian Patent Organization 025407 ПОЛИМОРФНАЯ ФОРМА I (S)-2-(1-(9H-ПУРИН-6-ИЛАМИНО)ПРОПИЛ)-5-ФТОР-3-ФЕНИЛХИНАЗОЛИН-4(3H)-ОНА (POLYMORPHIC FORM I OF (S)-2-(1-(9H-PURIN-6-YLAMINO)PROPYL)-5-FLUORO-3-PHENYLQUINAZOLIN-4(3H)-ONE) ⤷  Sign Up
Montenegro 02695 HINAZOLINONI KAO INHIBITORI HUMANE FOSFATIDILONOZITOL 3- DELTA KINAZE (QUINAZOLINONES AS INHIBITORS OF HUMAN PHOSPHATIDYLINOSITOL 3-KINASE DELTA) ⤷  Sign Up
South Korea 101664511 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IDELALISIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761540 CR 2017 00007 Denmark ⤷  Sign Up PRODUCT NAME: IDELALISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/938 20140919
1761540 SPC/GB17/024 United Kingdom ⤷  Sign Up PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/14/938/001-002 20140919; UK PLGB 11972/0031 20140919; UK PLGB 11972/0032 20140919
1761540 656 Finland ⤷  Sign Up
1761540 CA 2017 00007 Denmark ⤷  Sign Up PRODUCT NAME: IDELALISIB; REG. NO/DATE: EU/1/14/938 20140924
1761540 C 2017 009 Romania ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: IDELALISIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/938 20140918
1761540 17C1007 France ⤷  Sign Up PRODUCT NAME: IDELALISIB OU SEL DE CELUI-CI ACCEPTABLE D'UN POINT DE VUE PHARMACEUTIQUE; REGISTRATION NO/DATE: EU/1/14/938 20140919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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