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Last Updated: September 25, 2022

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

See drug prices for ZYDELIG

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
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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-on- e
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapies for hematologic malignancies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL

Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Patent Number: See Plans and Pricing
Patent Expiration: 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
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 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 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
>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 See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 See Plans and Pricing See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 13203620
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014021935
Estimated Expiration: See Plans and Pricing

Canada

Patent: 64305
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14002358
Estimated Expiration: See Plans and Pricing

China

Patent: 4334560
Estimated Expiration: See Plans and Pricing

Patent: 6146506
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 71131
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 140460
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 14020478
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5407
Estimated Expiration: See Plans and Pricing

Patent: 1491473
Estimated Expiration: See Plans and Pricing

Patent: 1690461
Estimated Expiration: See Plans and Pricing

Patent: 1691327
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 34241
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 06345
Estimated Expiration: See Plans and Pricing

India

Patent: 05DEN2014
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7644
Estimated Expiration: See Plans and Pricing

Japan

Patent: 15509537
Estimated Expiration: See Plans and Pricing

Patent: 16104823
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 14010656
Estimated Expiration: See Plans and Pricing

Moldova, Republic of

Patent: 140100
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 379
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9684
Estimated Expiration: See Plans and Pricing

Peru

Patent: 141792
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 014501920
Estimated Expiration: See Plans and Pricing

Poland

Patent: 34241
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 34241
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201405446P
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 34241
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1405870
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 140133590
Estimated Expiration: See Plans and Pricing

Spain

Patent: 48273
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1350486
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 656
Estimated Expiration: See Plans and Pricing

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
Japan 2012508775 See Plans and Pricing
Denmark 1438052 See Plans and Pricing
Spain 2358785 See Plans and Pricing
New Zealand 532206 Inhibitors of human phosphatidyl-inositol 3-kinase delta See Plans and Pricing
Denmark 1761540 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZYDELIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 CA 2017 00007 Denmark See Plans and Pricing PRODUCT NAME: IDELALISIB; REG. NO/DATE: EU/1/14/938 20140924
1761540 C01761540/01 Switzerland See Plans and Pricing PRODUCT NAME: IDELALISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65291 22.01.2015
1761540 C20170009 00226 Estonia See Plans and Pricing PRODUCT NAME: IDELALISIIB;REG NO/DATE: EU/1/14/938 19.09.2014
1761540 9/2017 Austria See Plans and Pricing PRODUCT NAME: IDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 (MITTEILUNG) 20140919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Boehringer Ingelheim
Colorcon
McKinsey
Dow

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.