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Last Updated: October 22, 2021

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VENETOCLAX - Generic Drug Details

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What are the generic sources for venetoclax and what is the scope of freedom to operate?

Venetoclax is the generic ingredient in one branded drug marketed by Abbvie Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Venetoclax has one hundred and eighty-four patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for VENETOCLAX
Recent Clinical Trials for VENETOCLAX

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

SponsorPhase
Melbourne HealthPhase 1
Fred Hutchinson Cancer Research CenterPhase 2
AstraZenecaPhase 2

See all VENETOCLAX clinical trials

Pharmacology for VENETOCLAX
Drug ClassBCL-2 Inhibitor
Mechanism of ActionP-Glycoprotein Inhibitors
Physiological EffectIncreased Cellular Death
Paragraph IV (Patent) Challenges for VENETOCLAX
Tradename Dosage Ingredient NDA Submissiondate
VENCLEXTA TABLET;ORAL venetoclax 208573 2020-04-13

US Patents and Regulatory Information for VENETOCLAX

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 208573-002 Apr 11, 2016 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-001 Apr 11, 2016 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 VENETOCLAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435432 2017/023 Ireland ⤷  Free Forever Trial PRODUCT NAME: VENETOCLAX (VENCLYXTO); REGISTRATION NO/DATE: EU/1/16/1138 20161205
2435432 C20170017 00231 Estonia ⤷  Free Forever Trial PRODUCT NAME: VENETOKLAKS;REG NO/DATE: EU/1/16/1138 07.12.2016
2435432 17C1018 France ⤷  Free Forever Trial PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207
2435432 300873 Netherlands ⤷  Free Forever Trial PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Baxter
McKinsey
Medtronic
Moodys

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