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Last Updated: November 22, 2024

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ZYDELIG Drug Patent 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 eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eleven patent family members in forty 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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for ZYDELIG
International Patents:111
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 106
Clinical Trials: 13
Patent Applications: 1,009
Drug Prices: Drug price information for ZYDELIG
What excipients (inactive ingredients) are in ZYDELIG?ZYDELIG excipients list
DailyMed Link:ZYDELIG at DailyMed
Drug patent expirations by year for ZYDELIG
Drug Prices for ZYDELIG

See drug prices for ZYDELIG

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Prospect Creek FoundationPhase 1
Oregon Health and Science UniversityPhase 1

See all ZYDELIG clinical trials

Pharmacology for ZYDELIG
Paragraph IV (Patent) Challenges for ZYDELIG
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 ZYDELIG

ZYDELIG is protected by nine US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZYDELIG is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZYDELIG

Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-on- e
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-on- e
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL

5-fluoro-3-phenyl-2[1-(9H-purin-6-ylamino)propyl]-3H-quinazolin-4-one and 6-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)ethyl]-3H-quinazolin-4-one as inhibitors of human phosphatidylinositol 3-kinase delta
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL

5-fluoro-3-phenyl-2-[1-(9h-purin-6-ylamino)propyl]-3h-quinazolin-4-one as an inhibitor of human phosphatidylinositol 3-kinase delta
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: INHIBITION ON PI3K KINASE

Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-on- e
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Therapies for hematologic malignancies
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH RITUXIMAB, FOR THE TREATMENT OF PATIENTS WITH RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA OR [RELAPSED] SMALL LYMPHOCYTIC LYMPHOMA

Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL

Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  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 205858-001 Jul 23, 2014 RX Yes No ⤷  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 ⤷  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 Y ⤷  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 ZYDELIG

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 ZYDELIG

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 ZYDELIG

When does loss-of-exclusivity occur for ZYDELIG?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 0253
Patent: FORMAS POLIMORFICAS DE (S)-2-(1-(9H-PURIN-6-ILAMINO)PROPIL)-5-FLUOR-3-FENILQUINAZOLIN-4(3H)-ONA
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 13203620
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014021935
Patent: formas polimórficas de (s)-2(l-(9h-purin-6-ilamino)propil)-5-fluoro-3-fenilquinazolina-4(3h)ona
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 64305
Patent: FORMES POLYMORPHES DE L'ACIDE -2-(1-(9H-PURINE-6-YLAMINO)PROPYL)-5-FLUORO-3-PHENYLQUINAZOLIN-4(3H)-ONE (POLYMORPHIC FORMS OF (S)-2-(1-(9H-PURIN-6-YLAMINO)PROPYL)-5-FLUORO-3-PHENYLQUINAZOLIN-4(3H)-ONE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 14002358
Patent: Formas polimorficas de (s)-2-(1-(9h-purin-6-ilamino)propil)-5-fluoro-3-fenilquinazolin-4(3h)-ona; metodos de preparacion; composiciones farmaceuticas que las comprenden y uso en el tratamiento del cancer.
Estimated Expiration: ⤷  Sign Up

China

Patent: 4334560
Patent: Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one
Estimated Expiration: ⤷  Sign Up

Patent: 6146506
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 71131
Patent: Formas polimórficas de (s)-2-(1-(9h-purin-6-ilamino)propil)-5-fluor-3-fenilquinazolin-4(3h)-ona
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 140460
Patent: FORMAS POLIMÓRFICAS DE (S)-2-(1-(9H-PURIN-6-ILAMINO)PROPIL)-5-FLUORO-3-FENILQUINAZOLIN-4(3H)-ONA
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 14020478
Patent: FORMAS POLIMÓRFICAS DE (S)-2-(1-(9H-PURIN-6-ILAMINO)PROPIL)-5-FLUORO-3-FENILQUINAZOLIN-4(3H)-ONA
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 5407
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 1491473
Patent: ПОЛИМОРФНЫЕ ФОРМЫ (S)-2-(1-(9H-ПУРИН-6-ИЛАМИНО)ПРОПИЛ)-5-ФТОР-3-ФЕНИЛХИНАЗОЛИН-4(3H)-ОНА
Estimated Expiration: ⤷  Sign Up

Patent: 1690461
Patent: ПОЛИМОРФНЫЕ ФОРМЫ (S)-2-(1-(9H-ПУРИН-6-ИЛАМИНО)ПРОПИЛ)-5-ФТОР-3-ФЕНИЛХИНАЗОЛИН-4(3H)-ОНА
Estimated Expiration: ⤷  Sign Up

Patent: 1691327
Patent: ПОЛИМОРФНЫЕ ФОРМЫ (S)-2-(1-(9H-ПУРИН-6-ИЛАМИНО)ПРОПИЛ)-5-ФТОР-3-ФЕНИЛХИНАЗОЛИН-4(3H)-ОНА
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 34241
Patent: FORMES POLYMORPHES DE L'ACIDE -2-(1-(9H-PURINE-6-YLAMINO)PROPYL)-5-FLUORO-3-PHÉNYLQUINAZOLIN-4(3H)-ONE (POLYMORPHIC FORMS OF (S)-2-(1-(9H-PURIN-6-YLAMINO)PROPYL)-5-FLUORO-3-PHENYLQUINAZOLIN-4(3H)-ONE)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 06345
Estimated Expiration: ⤷  Sign Up

India

Patent: 05DEN2014
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 15509537
Patent: (S)−2−(1−(9H−プリン−6−イルアミノ)プロピル)−5−フルオロ−3−フェニルキナゾリン−4(3H)−オンの多形性形態
Estimated Expiration: ⤷  Sign Up

Patent: 16104823
Patent: (S)−2−(1−(9H−プリン−6−イルアミノ)プロピル)−5−フルオロ−3−フェニルキナゾリン−4(3H)−オンの多形性形態 (POLYMORPHIC FORM OF (S)-2-(1-(9H-PURIN-6-YLAMINO)PROPYL)-5-FLUORO-3-PHENYL-QUINAZOLINE-4(3H)-ONE)
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 14010656
Patent: FORMAS POLIMORFICAS DE (S)-2-(1-(9H-PURIN-6-ILAMINO)PROPIL)-5-FLUO RO-3-FENILQUINAZOLIN-4(3H)-ONA. (POLYMORPHIC FORMS OF (S)-2-(1-(9H-PURIN-6-YLAMINO)PROPYL)- 5-FLUORO-3-PHENYLQUINAZOLIN-4(3H)-ONE.)
Estimated Expiration: ⤷  Sign Up

Moldova, Republic of

Patent: 140100
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 379
Patent: Formes polymorphes de l'acide -2-(1-(9h-purine-6-ylamino)propyl)-5-fluoro-3-phénylquinazolin-4(3h)-one
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 9684
Patent: Polymorphic forms of (s)-2-(1-(9h-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3h)-one
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 141792
Patent: FORMAS POLIMORFICAS DE (S)-2-(1-(9H-PURIN-6-ILAMINO)PROPIL)-5-FLUOR-3-FENILQUINAZOLIN-4(3H)-ONA
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 014501920
Patent: POLYMORPHIC FORMS OF (S)-2-(1-(9H-PURIN-6-YLAMINO)PROPYL)-5-FLUORO-3-PHENYLQUINAZOLIN-4(3H)-ONE
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 34241
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 34241
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201405446P
Patent: POLYMORPHIC FORMS OF (S)-2-(1-(9H-PURIN-6-YLAMINO)PROPYL)-5-FLUORO-3-PHENYLQUINAZOLIN-4(3H)-ONE
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 34241
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1405870
Patent: POLYMORPHIC FORMS OF (S)-2-(1-(9H-PURIN-6-YLAMINO)-5-FLUORO-3-PHENYLQUINAZOLIN-4(3H)-ONE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 140133590
Patent: POLYMORPHIC FORMS OF (S)-2-(1-(9H-PURIN-6-YLAMINO)PROPYL)-5-FLUORO-3-PHENYLQUINAZOLIN-4(3H)-ONE
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 48273
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 1350486
Patent: Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 656
Patent: POLIMORFOS DE (S)?2?(1?(9H?PURIN?6?ILAMINO)PROPIL)?5?FLUOR?3?FENILQUINAZOLIN?4(3H)?ONA, COMPOSICIÓN Y MÉTODO DE PREPARACIÓN
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZYDELIG around the world.

Country Patent Number Title Estimated Expiration
Hungary 0300497 ⤷  Sign Up
Israel 231360 מעכבי פוספאטידיל-אינוסיטול 3-קינאז דלתא (Inhibitors of human phosphatidyl-inositol 3-kinase delta) ⤷  Sign Up
Poland 3153514 ⤷  Sign Up
Spain 2358785 ⤷  Sign Up
Poland 358590 ⤷  Sign Up
New Zealand 734110 Therapies for hematologic malignancies ⤷  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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZYDELIG

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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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.