Venetoclax - Generic Drug Details

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

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

Venetoclax has two hundred and fifty-seven patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for venetoclax

International Patents:	257
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	443
Patent Applications:	3,123
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for venetoclax
What excipients (inactive ingredients) are in venetoclax?	venetoclax excipients list
DailyMed Link:	venetoclax at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for venetoclax

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 venetoclax

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

Sponsor	Phase
German CLL Study Group	Phase 1/Phase 2
Stichting Hemato-Oncologie voor Volwassenen Nederland	Phase 1/Phase 2
Nordic CLL Study Group	Phase 1/Phase 2

See all venetoclax clinical trials

Pharmacology for venetoclax

Drug Class	BCL-2 Inhibitor
Mechanism of Action	P-Glycoprotein Inhibitors
Physiological Effect	Increased Cellular Death

Paragraph IV (Patent) Challenges for VENETOCLAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VENCLEXTA	Tablets	venetoclax	10 mg, 50 mg and 100 mg	208573	2	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	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes			Y	Y
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-001	Apr 11, 2016		RX	Yes	No				Y
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No

EU/EMA Drug Approvals for venetoclax

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH Co. KG	Venclyxto	venetoclax	EMEA/H/C/004106 Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.Venclyxto monotherapy is indicated for the treatment of CLL:- in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or- in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.	Authorised	no	no	no	2016-12-04

International Patents for venetoclax

Country	Patent Number	Title	Estimated Expiration
South Africa	201401440	PROCESS FOR PREPARING A SOLID DISPERSION CONTAINING AN APOPTOSIS-INDUCING AGENT
Israel	269092	תהליך להכנת 2-(9h-קרבזול-4-אילאוקסי)-4-(4-{[2-(4-כלורופניל)-4,4-דימתילציקלוהקס-1-אן-1-איל]מתיל}פיפרזין-1-איל)-n-({4-[(1-מתילפיפרידין-4-איל)אמינו]3-ניטרופניל}סולפוניל)בנזמיד (Process for preparing 2-(9h-carbazol-4-yloxy)-4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-n-({4-[(1-methylpiperidin-4-yl)amino]-3-nitrophenyl}sulfonyl)benzamide)
Japan	2020023545	癌ならびに免疫疾患および自己免疫疾患の治療用のアポトーシス誘発剤 (APOPTOSIS-INDUCING AGENT FOR TREATMENT OF CANCER AND IMMUNE AND AUTOIMMUNE DISEASES)
Norway	2613769

Supplementary Protection Certificates for venetoclax

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435432	21/2017	Austria		PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 (MITTEILUNG) 20161207
2435432	300873	Netherlands		PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207
2435432	CR 2017 00021	Denmark		PRODUCT NAME: VENETOCLAX; REG. NO/DATE: EU/1/16/1138/001-007 20161207
2435432	17C1018	France		PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207