ZYDELIG Drug Patent Profile

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 four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-five patent family members in thirty 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 has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ZYDELIG

International Patents:	65
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	13
Patent Applications:	4,862
Drug Prices:	Drug price information for ZYDELIG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZYDELIG
What excipients (inactive ingredients) are in ZYDELIG?	ZYDELIG excipients list
DailyMed Link:	ZYDELIG at DailyMed

See drug prices for ZYDELIG

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZYDELIG

Constraining patent/regulatory exclusivity:

9,469,643

NDA:

205858

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

Sponsor	Phase
Loxo Oncology, Inc.	Phase 3
Prospect Creek Foundation	Phase 1
Oregon Health and Science University	Phase 1

See all ZYDELIG clinical trials

Pharmacology for ZYDELIG

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A Inhibitors Kinase Inhibitors

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 four US patents.

This potential generic entry date is based on patent 9,469,643.

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

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	8,865,730		Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	10,730,879		Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No	10,730,879		Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	9,469,643			Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No	9,492,449
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No	9,469,643			Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	8,865,730		Y	Y

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	8,980,901
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	6,800,620
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	9,149,477
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	8,637,533
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	8,980,901
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	RE44638
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	8,492,389

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/003843Zydelig 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

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

India

Japan

Mexico

Moldova, Republic of

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Uruguay

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	4642309
Portugal	1761540
Eurasian Patent Organization	008241	ИНГИБИТОРЫ ФОСФАТИДИЛИНОЗИТОЛ-3-КИНАЗЫ ДЕЛЬТА ЧЕЛОВЕКА (INHIBITORS OF HUMAN PHOSPHATIDYL-INOSITOL 3-KINASE DELTA)
China	104334560
Brazil	PI0110371	inibidores de fosfatidilinositol 3-cinase delta humana
Hungary	230554	Humán foszfatidilinozit-3-kináz-delta inhibitorok és alkalmazásuk (Inhibitors of human phosphatidyl-inositol 3-kinase delta)
Denmark	1278748

Supplementary Protection Certificates for ZYDELIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761540	C20170009 00226	Estonia		PRODUCT NAME: IDELALISIIB;REG NO/DATE: EU/1/14/938 19.09.2014
1761540	656	Finland
1761540	132017000031007	Italy		PRODUCT NAME: IDELALISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYDELIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/938, 20140919
1761540	PA2017004,C1761540	Lithuania		PRODUCT NAME: IDELALISIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/938 20140918
1761540	CA 2017 00007	Denmark		PRODUCT NAME: IDELALISIB; REG. NO/DATE: EU/1/14/938 20140924
1761540	C01761540/01	Switzerland		PRODUCT NAME: IDELALISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65291 22.01.2015
1761540	122017000008	Germany		PRODUCT NAME: LDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 20140918

ZYDELIG: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

What is ZYDELIG?

ZYDELIG (idelalisib) is a kinase inhibitor targeting phosphoinositide 3-kinase delta (PI3Kδ). This selective inhibition is designed to disrupt signaling pathways critical for the proliferation, survival, and trafficking of malignant B-cells. ZYDELIG is indicated for the treatment of certain B-cell malignancies, including relapsed chronic lymphocytic leukemia (CLL), relapsed follicular lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL). Its mechanism of action offers a targeted approach to these hematological cancers.

What are ZYDELIG's Approved Indications and Regulatory Status?

ZYDELIG received its initial U.S. Food and Drug Administration (FDA) approval on February 11, 2014, for relapsed follicular lymphoma (FL), relapsed small lymphocytic lymphoma (SLL), and as monotherapy for relapsed chronic lymphocytic leukemia (CLL) in patients who have received at least two prior therapies [1]. Subsequently, its indication was expanded on July 29, 2015, to include combination therapy with rituximab for patients with relapsed CLL who are not suitable for chemoimmunotherapy [1].

The European Medicines Agency (EMA) also approved ZYDELIG. In the European Union, it received marketing authorization on October 17, 2014, for the treatment of adult patients with relapsed CLL who are refractory to, or have relapsed after, at least one prior line of therapy. It is also approved for adult patients with relapsed FL and SLL who have received at least two prior systemic treatment regimens and whose disease is