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Venclexta is a drug marketed by Abbvie Inc and is included in one NDA. There are six 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.
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
Summary for VENCLEXTA
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||83|
|Drug Prices:||Drug price information for VENCLEXTA|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for VENCLEXTA|
|What excipients (inactive ingredients) are in VENCLEXTA?||VENCLEXTA excipients list|
|DailyMed Link:||VENCLEXTA at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for VENCLEXTA
*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
|Fred Hutchinson Cancer Research Center||Phase 2|
|F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute||Phase 2|
Pharmacology for VENCLEXTA
|Country||Patent Number||Estimated Expiration|
|Singapore||190361||⤷ Free Forever Trial|
|Croatia||P20151001||⤷ Free Forever Trial|
|Serbia||56697||⤷ Free Forever Trial|
|Ukraine||106079||⤷ Free Forever Trial|
|Uruguay||37825||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
|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|
|2435432||PA2017015,C2435432||Lithuania||⤷ Free Forever Trial||PRODUCT NAME: VENETOKLAKSAS; REGISTRATION NO/DATE: EU/1/16/1138 20161205|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|