Last Updated: May 23, 2026

idelalisib - Profile

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What are the generic sources for idelalisib and what is the scope of patent protection?

Idelalisib is the generic ingredient in two branded drugs marketed by Natco and Gilead Sciences Inc, and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Idelalisib has sixty-five patent family members in thirty countries.

Summary for idelalisib

International Patents:	65
US Patents:	4
Tradenames:	2
Applicants:	2
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Natco	IDELALISIB	idelalisib	TABLET;ORAL	216921-001	Feb 17, 2026	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Natco	IDELALISIB	idelalisib	TABLET;ORAL	216921-002	Feb 17, 2026	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	AB	RX	Yes	No	8,865,730	⤷ Start Trial	Y	Y		⤷ Start Trial
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	AB	RX	Yes	No	9,492,449	⤷ Start Trial				⤷ Start Trial
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	AB	RX	Yes	No	9,469,643	⤷ Start Trial		Y		⤷ Start Trial
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	AB	RX	Yes	No	10,730,879	⤷ Start Trial	Y	Y		⤷ Start Trial
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	9,149,477	⤷ Start Trial
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	8,138,195	⤷ Start Trial
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	8,138,195	⤷ Start Trial
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	6,800,620	⤷ Start Trial
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	6,800,620	⤷ Start Trial
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	8,980,901	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for idelalisib

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for idelalisib

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Country	Patent Number	Title	Estimated Expiration
Australia	2018247326		⤷ Start Trial
Australia	2019213337		⤷ Start Trial
Japan	2015155436	血液学的な悪性疾患のための療法 (THERAPY FOR HEMATOLOGIC MALIGNANCY)	⤷ Start Trial
Singapore	11201405446P	POLYMORPHIC FORMS OF (S)-2-(1-(9H-PURIN-6-YLAMINO)PROPYL)-5-FLUORO-3-PHENYLQUINAZOLIN-4(3H)-ONE	⤷ Start Trial
Canada	2743642		⤷ Start Trial
Eurasian Patent Organization	025407		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for idelalisib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761540	PA2017004,C1761540	Lithuania	⤷ Start Trial	PRODUCT NAME: IDELALISIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/938 20140918
1761540	CA 2017 00007	Denmark	⤷ Start Trial	PRODUCT NAME: IDELALISIB; REG. NO/DATE: EU/1/14/938 20140924
1761540	C 2017 009	Romania	⤷ Start Trial	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	2017/006	Ireland	⤷ Start Trial	PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/14/938 20140918
1761540	300867	Netherlands	⤷ Start Trial	PRODUCT NAME: IDELALISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/938 20140919
1761540	CR 2017 00007	Denmark	⤷ Start Trial	PRODUCT NAME: IDELALISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/938 20140919
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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