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.

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

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

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.

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
Natco	IDELALISIB	idelalisib	TABLET;ORAL	216921-001	Feb 17, 2026		DISCN	No	No
Natco	IDELALISIB	idelalisib	TABLET;ORAL	216921-002	Feb 17, 2026		DISCN	No	No
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No			Y	Y

Expired US Patents for idelalisib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014

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/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 idelalisib

Country	Patent Number	Title	Estimated Expiration
Argentina	090253
Australia	2013203620
Brazil	112014021935

Supplementary Protection Certificates for idelalisib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761540	PA2017004,C1761540	Lithuania		PRODUCT NAME: IDELALISIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/938 20140918
1761540	9/2017	Austria		PRODUCT NAME: IDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 (MITTEILUNG) 20140919
1761540	C01761540/01	Switzerland		PRODUCT NAME: IDELALISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65291 22.01.2015