IDELALISIB - Generic Drug Details

What are the generic drug sources for idelalisib and what is the scope of freedom to operate?

Idelalisib is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Idelalisib has one hundred and eleven patent family members in forty countries.

There are two drug master file entries for idelalisib. One supplier is listed for this compound.

Summary for IDELALISIB

International Patents:	111
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	61
Patent Applications:	2,356
What excipients (inactive ingredients) are in IDELALISIB?	IDELALISIB excipients list
DailyMed Link:	IDELALISIB at DailyMed

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.

Recent Clinical Trials for IDELALISIB

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Oslo University Hospital	Phase 2
ADC Therapeutics S.A.	Phase 2
Loxo Oncology, Inc.	Phase 3

See all IDELALISIB clinical trials

Pharmacology for IDELALISIB

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

Anatomical Therapeutic Chemical (ATC) Classes for IDELALISIB

L01EM	Phosphatidylinositol-3-kinase (Pi3K) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No			Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No			Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No

Expired US Patents for IDELALISIB

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

International Patents for IDELALISIB

Country	Patent Number	Title	Estimated Expiration
South Korea	20170060179	혈액 종양에 대한 요법 (THERAPIES FOR HEMATOLOGIC MALIGNANCIES)
European Patent Office	2612862	Quinazolinones utilisees en tant qu'inhibiteurs de la phosphatidylinositol 3-kinase delta humaine (Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta)
Mexico	2014010656	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.)
Hong Kong	1206345	-嘌呤- -基氨基 丙基 -氟- -苯基喹唑啉- -酮的多晶型物 (POLYMORPHIC FORMS OF (S)-2-(1-(9H-PURIN-6-YLAMINO)PROPYL)-5-FLUORO-3- PHENYLQUINAZOLIN-4(3H)-ONE (S)-2-(1-(9H--6-))-5--3--4(3H)-)
New Zealand	631024	Therapies for hematologic malignancies
Denmark	1761540

Supplementary Protection Certificates for IDELALISIB

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	SPC/GB17/024	United Kingdom		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	122017000008	Germany		PRODUCT NAME: LDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 20140918
1761540	17C1007	France		PRODUCT NAME: IDELALISIB OU SEL DE CELUI-CI ACCEPTABLE D'UN POINT DE VUE PHARMACEUTIQUE; REGISTRATION NO/DATE: EU/1/14/938 20140919
1761540	9/2017	Austria		PRODUCT NAME: IDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 (MITTEILUNG) 20140919
1761540	1790006-9	Sweden		PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/938 20140919