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Last Updated: January 20, 2020

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ZYDELIG Drug Profile

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When do Zydelig patents expire, and when can generic versions of Zydelig launch?

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

This drug has one hundred and sixty-one patent family members in forty-six countries.

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.

US ANDA Litigation and Generic Entry Outlook for Zydelig

  Start Trial

Zydelig was eligible for patent challenges on July 23rd, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 2nd, 2033. This may change due to patent challenges or generic licensing.

Drug patent expirations by year for ZYDELIG
Drug Prices for ZYDELIG

See drug prices 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.

Recent Clinical Trials for ZYDELIG

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

SponsorPhase
Zhonglin HaoPhase 1/Phase 2
Gilead SciencesPhase 1/Phase 2
Merck Sharp & Dohme Corp.Phase 1/Phase 2

See all ZYDELIG clinical trials

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
1453810-72-4
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
BCP02532
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
D10560
DB09054
EX-A1242
EX-A330
FT-0699107
FT-0773473
GS 1101
GS-1101
GS-11CAL-101
GTPL6741
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
MLS006010985
MolPort-016-633-355
NCGC00262603-01
NCGC00262603-02
PB25727
Q-4533
QCR-36
RL05396
s2226
SC-86075
SCHEMBL16782604
SCHEMBL356400
SMR004702787
ST2408278
SW219823-1
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   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ZYDELIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761540 2017/006 Ireland   Start Trial PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/14/938 20140918
1761540 LUC00005 Luxembourg   Start Trial PRODUCT NAME: IDELALISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/938 20140919
1761540 122017000008 Germany   Start Trial PRODUCT NAME: LDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 20140918
1761540 C01761540/01 Switzerland   Start Trial PRODUCT NAME: IDELALISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65291 22.01.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Dow
Colorcon
McKesson
Moodys

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