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Last Updated: June 25, 2021

DrugPatentWatch Database Preview

VENCLEXTA Drug Profile


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Which patents cover Venclexta, and when can generic versions of Venclexta launch?

Venclexta is a drug marketed by Abbvie Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-four 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.

DrugPatentWatch® Generic Entry Outlook for Venclexta

Venclexta was eligible for patent challenges on April 11, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 29, 2032. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for VENCLEXTA
Drug Prices for VENCLEXTA

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DrugPatentWatch® Estimated 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
BayerPhase 1/Phase 2
AstraZenecaPhase 1/Phase 2
Austin I KimPhase 1/Phase 2

See all VENCLEXTA clinical trials

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

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 208573-002 Apr 11, 2016 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No   Get Started Free   Get Started Free   Get Started Free
>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 2017/023 Ireland   Get Started Free PRODUCT NAME: VENETOCLAX (VENCLYXTO); REGISTRATION NO/DATE: EU/1/16/1138 20161205
2435432 2017023 Norway   Get Started Free PRODUCT NAME: VENETOKLAKS, DVS. 4-(4-(2-(4-; REG. NO/DATE: EU/1/16/1138 20161213
2435432 LUC00020 Luxembourg   Get Started Free PRODUCT NAME: VENETOCLAX (VENCLYXTO); AUTHORISATION NUMBER AND DATE: EU/1/16/1138 20161207
2435432 C201730016 Spain   Get Started Free PRODUCT NAME: VENETOCLAX; NATIONAL AUTHORISATION NUMBER: EU/1/16/1138; DATE OF AUTHORISATION: 20161205; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1138; DATE OF FIRST AUTHORISATION IN EEA: 20161205
2435432 132017000054735 Italy   Get Started Free PRODUCT NAME: VENETOCLAX(VENCLYXTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1138, 20161207
2435432 C02435432/01 Switzerland   Get Started Free PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66235 08.05.2018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
McKesson
Baxter
Boehringer Ingelheim
Mallinckrodt

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 verification 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.