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Last Updated: January 18, 2020

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VENCLEXTA Drug Profile

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When do Venclexta patents expire, and what generic alternatives are available?

Venclexta is a drug marketed by Abbvie Inc and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in VENCLEXTA is venetoclax. One supplier is listed for this compound. Additional details are available on the venetoclax profile page.

US ANDA Litigation and Generic Entry Outlook for Venclexta

  Start Trial

Venclexta will be eligible for patent challenges on April 11th, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 27th, 2031. This may change due to patent challenges or generic licensing.

Summary for VENCLEXTA
Drug patent expirations by year for VENCLEXTA
Drug Prices for VENCLEXTA

See drug prices for VENCLEXTA

Generic Entry Opportunity Date for VENCLEXTA
Generic Entry Date for VENCLEXTA*:
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 VENCLEXTA

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

SponsorPhase
Emory UniversityPhase 2
Janssen Research & Development, LLCPhase 1
argenx BVBAPhase 1

See all VENCLEXTA clinical trials

Pharmacology for VENCLEXTA
Drug ClassBCL-2 Inhibitor
Mechanism of ActionP-Glycoprotein Inhibitors
Physiological EffectIncreased Cellular Death
Synonyms for VENCLEXTA
1257044-40-8
2-((1H-pyrrolo[2,3-b]pyridin-5-yl)oxy)-4-(4-((4'-chloro-5,5-dimethyl-3,4,5,6-tetrahydro-[1,1'-biphenyl]-2-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-(((tetrahydro-2H-pyran-4-yl)methyl)amino)phenyl
2-(1H-Pyrrolo[2,3-b]pyridin-5-yloxy)-4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-enyl)methyl)piperazin-1-yl)-N-(3-nitro-4-((tetrahydro-2H-pyran-4-yl)methy
4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide
4-[4-[[2-(4-Chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl]methyl]-1-piperazinyl]-N-[[3-nitro-4-[[(tetrahydro-2H-pyran-4-yl)methyl]amino]phenyl]sulfonyl]-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)-benzamide
4-[4-[[2-(4-chlorophenyl)-4,4-dimethylcyclohexen-1-yl]methyl]piperazin-1-yl]-N-[3-nitro-4-(oxan-4-ylmethylamino)phenyl]sulfonyl-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide
4-{4-[(4'-chloro-5,5-dimethyl[3,4,5,6-tetrahydro[1,1'-biphenyl]]-2-yl)methyl]piperazin-1-yl}-N-(3-nitro-4-{[(oxan-4-yl)methyl]amino}benzene-1-sulfonyl)-2-[(1H-pyrrolo[2,3-b]pyridin-5-yl)oxy]benzamide
ABT 199
ABT-199
ABT-199 (GDC-0199)
ABT-199|||GDC 0199|||4-[4-[[2-(4-Chlorophenyl)-4,4-dimethylcyclohexen-1-yl]methyl]piperazin-1-yl]-N-[3-nitro-4-(oxan-4-ylmethylamino)phenyl]sulfonyl-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide
ABT199
AC-28754
AK170450
AKOS025289539
AOB5080
BC600499
BCP06811
BDBM189459
BDBM50162774
BDBM60828
C45H50ClN7O7S
CHEBI:133021
CHEMBL3137309
CS-1155
D10679
DB11581
DTXSID30154863
EX-A168
FT-0699586
GDC 0199
GDC 0199; Venetoclax
GDC-0199
GTPL8318
HMS3653J06
HY-15531
J-005269
J3.516.625D
KB-145916
KS-0000002C
KS-1470
MLS006010298
MolPort-028-720-431
N54AIC43PW
NCGC00345789-01
NCGC00345789-10
QC-11704
S8048
SB16499
SCHEMBL19236295
SCHEMBL523816
SMR004701366
SW219672-1
TRA0049558
UNII-N54AIC43PW
US9174982, 369
US9174982, 5
Venclexta (TN)
venclyxto
Venetoclax
Venetoclax (JAN/USAN/INN)
Venetoclax [USAN:INN]
Venetoclax(ABT-199)
W-6008
X3609
Z-3166
ZINC150338755

US Patents and Regulatory Information for VENCLEXTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-001 Apr 11, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No   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 VENCLEXTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435432 21/2017 Austria   Start Trial PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 (MITTEILUNG) 20161207
2435432 122017000031 Germany   Start Trial PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161205
2435432 CR 2017 00021 Denmark   Start Trial PRODUCT NAME: VENETOCLAX; REG. NO/DATE: EU/1/16/1138/001-007 20161207
2435432 PA2017015 Lithuania   Start Trial PRODUCT NAME: VENETOKLAKSAS; REGISTRATION NO/DATE: EU/1/16/1138 20161205
2435432 PA2017015,C2435432 Lithuania   Start Trial PRODUCT NAME: VENETOKLAKSAS; REGISTRATION NO/DATE: EU/1/16/1138 20161205
2435432 2017023 Norway   Start Trial PRODUCT NAME: VENETOKLAKS, DVS. 4-(4-(2-(4-; REG. NO/DATE: EU/1/16/1138 20161213
2435432 2017/023 Ireland   Start Trial PRODUCT NAME: VENETOCLAX (VENCLYXTO); REGISTRATION NO/DATE: EU/1/16/1138 20161205
>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:

AstraZeneca
Express Scripts
Baxter
Johnson and Johnson
Mallinckrodt
Harvard Business School

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