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Daiichi Sankyo
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AstraZeneca
Queensland Health
Cipla
Cerilliant
Argus Health
Citi
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Generated: September 19, 2018

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ZYDELIG Drug Profile

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Which patents cover Zydelig, and what generic alternatives are available?

Zydelig is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are twelve patents protecting this drug.

The generic ingredient in ZYDELIG is idelalisib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the idelalisib profile page.

Drug patent expirations by year for ZYDELIG
Generic Entry Opportunity Date for ZYDELIG
Generic Entry Date for ZYDELIG*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Pharmacology for ZYDELIG
Synonyms for ZYDELIG
(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
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 (TN)

US Patents and Regulatory Information for ZYDELIG

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

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Non-Orange Book US Patents for ZYDELIG

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
8,993,583 5-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)propyl]-3H-quinazolin-4-one and 6-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)ethyl]-3H-quinazolin-4-one as inhibitors of human phosphatidylinositol 3-kinase delta ➤ Sign Up
6,518,277 Inhibitors of human phosphatidylinositol 3-kinase delta ➤ Sign Up
9,487,772 Inhibitors of human phosphatidylinositol 3-kinase delta ➤ Sign Up
9,238,070 Therapies for hematologic malignancies ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ZYDELIG

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0867 Netherlands ➤ Sign Up PRODUCT NAME: IDELALISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/938 20140919
9 7-2017 Slovakia ➤ Sign Up PRODUCT NAME: IDELALISIB VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/938 20140919
0170009 00226 Estonia ➤ Sign Up PRODUCT NAME: IDELALISIIB;REG NO/DATE: EU/1/14/938 19.09.2014
2017004 Lithuania ➤ Sign Up PRODUCT NAME: IDELALISIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/938 20140918
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Colorcon
AstraZeneca
Queensland Health
Cipla
Cerilliant
Argus Health
Citi
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.