Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
Mallinckrodt
McKinsey
Johnson and Johnson
AstraZeneca

Last Updated: November 27, 2022

Idelalisib - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Idelalisib has one hundred and thirteen 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:113
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 98
Clinical Trials: 60
Patent Applications: 2,788
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in idelalisib?idelalisib excipients list
DailyMed Link:idelalisib at DailyMed
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
Virginia Commonwealth UniversityPhase 1

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 205858-001 Jul 23, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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
Montenegro 02695 HINAZOLINONI KAO INHIBITORI HUMANE FOSFATIDILONOZITOL 3- DELTA KINAZE (QUINAZOLINONES AS INHIBITORS OF HUMAN PHOSPHATIDYLINOSITOL 3-KINASE DELTA) See Plans and Pricing
Spain 2873875 See Plans and Pricing
Australia 2018204264 Therapies for hematologic malignancies See Plans and Pricing
Moldova, Republic of 20140100 Forme polimorfe ale (S)-2-(1-(9H-purin-6-ilamino)propil)-5-fluoro-3-fenilchinazolin-4(3H)-onei;Forme polimorfe ale (S)-2-(1-(9H-purin-6-ilamino)propil)-5-fluoro-3-fenilchinazolin-4(3H)-onei (Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one) See Plans and Pricing
China 104334560 Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one See Plans and Pricing
Slovenia 2834241 See Plans and Pricing
European Patent Office 1761540 QUINAZOLINONES UTILISEES EN TANT QU'INHIBITEURS DE LA PHOSPHATIDYLINOSITOL 3-KINASE DELTA HUMAINE (QUINAZOLINONES AS INHIBITORS OF HUMAN PHOSPHATIDYLINOSITOL 3-KINASE DELTA) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for idelalisib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761540 C20170009 00226 Estonia See Plans and Pricing PRODUCT NAME: IDELALISIIB;REG NO/DATE: EU/1/14/938 19.09.2014
1761540 17C1007 France See Plans and Pricing PRODUCT NAME: IDELALISIB OU SEL DE CELUI-CI ACCEPTABLE D'UN POINT DE VUE PHARMACEUTIQUE; REGISTRATION NO/DATE: EU/1/14/938 20140919
1761540 C 2017 009 Romania See Plans and Pricing 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 656 Finland See Plans and Pricing
1761540 1790006-9 Sweden See Plans and Pricing PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/938 20140919
1761540 CA 2017 00007 Denmark See Plans and Pricing PRODUCT NAME: IDELALISIB; REG. NO/DATE: EU/1/14/938 20140924
1761540 LUC00005 Luxembourg See Plans and Pricing PRODUCT NAME: IDELALISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/938 20140919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Express Scripts
Mallinckrodt
Harvard Business School
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.