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Idelalisib - Generic Drug Details

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

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

Idelalisib has one hundred and forty-nine patent family members in forty-four countries.

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

Summary for idelalisib

International Patents:	149
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	75
Clinical Trials:	50
Patent Applications:	161
DailyMed Link:	idelalisib at DailyMed

Pharmacology for idelalisib

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

Synonyms for idelalisib

(S)-2-(1-((9H-Purin-6-yl)amino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one

(S)-2-(1-(1H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one

(S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one

(S)-5-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)-propyl]-3H-quinazolin-4-one

1146702-54-6

4(3H)-QUINAZOLINONE, 5-FLUORO-3-PHENYL-2-[(1S)-1-(1H-PURIN-6-YLAMINO)PROPYL]-

40L

5-fluoro-3-phenyl-2-((1s)-1-(9h-purin-6-ylamino)propyl)-4(3h)-quinazolinone

5-Fluoro-3-phenyl-2-((S)-1-(9H-purin-6-ylamino)-propyl)-3H-quinazolin-4-one

5-fluoro-3-phenyl-2-[(1S)-1-(3H-purin-6-ylamino)propyl]quinazolin-4(3H)-one

5-fluoro-3-phenyl-2-[(1S)-1-(7H-purin-6-ylamino)propyl]quinazolin-4-one

5-Fluoro-3-Phenyl-2-[(1s)-1-(7h-Purin-6-Ylamino)propyl]quinazolin-4(3h)-One

5-FLUORO-3-PHENYL-2-[(1S)-1-(9H-PURIN-6-YLAMINO)PROPYL]-4(3H)-QUINAZOLINONE

5-fluoro-3-phenyl-2-[(1S)-1-(9H-purin-6-ylamino)propyl]quinazolin-4-one

870281-82-6

ABP000109

AC-28394

AJ-64558

AK145603

AKOS022186334

AOB87313

AX8224801

BC638838

BCP9000471

BCPP000307

BDBM50403068

BRD-K60866521-001-01-4

C22H18FN7O

CAL 101

CAL-101

CAL-101 (GS-1101)

CAL-101 (Idelalisib, GS-1101)

CAL-101/CAL101

CAL101

CAL101;S2226;870281-82-6

cc-41

CHEBI:82701

CHEMBL2216870

CS-0256

D0J5VR

D10560

DB09054

EX-A1242

EX-A330

FT-0699107

FT-0773473

GS 1101

GS-1101

GS-11CAL-101

GTPL6741

HE106857

HY-13026

Idelalisib (CAL-101 GS-1101)

Idelalisib (JAN/USAN/INN)

Idelalisib [USAN:INN]

Idelalisib; CAL-101

IFSDAJWBUCMOAH-HNNXBMFYSA-N

J-517532

KB-48629

KS-000007GA

LS41100

MFCD19443647

MLS006010985

MolPort-016-633-355

NCGC00262603-01

PB25727

PBCML-101 (Idelalisib, GS-1101)

Q-4533

QCR-36

RL05396

s2226

SC-86075

SCHEMBL16782604

SCHEMBL356400

SMR004702787

ST2408278

Tube701

UNII-YG57I8T5M0

X7435

YG57I8T5M0

ZINC13986658

Zydelig

Zydelig (TN)

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

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Non-Orange Book US Patents for idelalisib

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,518,277	Inhibitors of human phosphatidylinositol 3-kinase delta
6,667,300	Inhibitors of human phosphatidylinositol 3-kinase delta
8,623,881	Inhibitors of human phosphatidylinositol 3-kinase delta
8,653,077	Inhibitors of human phosphatidylinositol 3-kinase delta

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International Patents for idelalisib

Country	Document Number	Estimated Expiration
Poland	213200
Cyprus	1116299
South Korea	20170060179
Australia	2017200837

Supplementary Protection Certificates for idelalisib

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017 00007	Denmark		PRODUCT NAME: IDELALISIB; REG. NO/DATE: EU/1/14/938 20140924
0867	Netherlands		PRODUCT NAME: IDELALISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/938 20140919
2017000008	Germany		PRODUCT NAME: LDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 20140918
0170009 00226	Estonia		PRODUCT NAME: IDELALISIIB;REG NO/DATE: EU/1/14/938 19.09.2014