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Idelalisib - Generic Drug Details

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:	69
Clinical Trials:	50
Patent Applications:	161
Drug Prices:	see low prices
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

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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
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No	➤ Sign Up	➤ Sign Up		Y		➤ Sign Up
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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.

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Patent No.	Title	Estimated Patent Expiration
8,623,881	Inhibitors of human phosphatidylinositol 3-kinase delta	➤ Sign Up
8,653,077	Inhibitors of human phosphatidylinositol 3-kinase delta	➤ Sign Up
9,487,772	Inhibitors of human phosphatidylinositol 3-kinase delta	➤ Sign Up
6,518,277	Inhibitors of human phosphatidylinositol 3-kinase delta	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Patents for idelalisib

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Country	Document Number	Estimated Expiration
Canada	2463294	➤ Sign Up
Serbia	55546	➤ Sign Up
Taiwan	201350486	➤ Sign Up
Mexico	2014010656	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for idelalisib

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90006-9	Sweden	➤ Sign Up	PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/938 20140919
2017004	Lithuania	➤ Sign Up	PRODUCT NAME: IDELALISIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/938 20140918
2017000008	Germany	➤ Sign Up	PRODUCT NAME: LDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 20140918
2017 00007	Denmark	➤ Sign Up	PRODUCT NAME: IDELALISIB; REG. NO/DATE: EU/1/14/938 20140924
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description