Venetoclax - Generic Drug Details

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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-eight patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for venetoclax

International Patents:	258
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	473
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

Generic Entry Date for venetoclax^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Benjamin Tomlinson	Phase 1/Phase 2
Antonio M Jimenez Jimenez	Phase 1
Flamingo Therapeutics NV	Phase 1

See all venetoclax clinical trials

Pharmacology for venetoclax

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

Anatomical Therapeutic Chemical (ATC) Classes for venetoclax

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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

EU/EMA Drug Approvals for venetoclax

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for venetoclax

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Country	Patent Number	Title	Estimated Expiration
South Korea	20180024025	아폽토시스―유도제를 포함하는 용융―압출된 고체 분산체 (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT)	⤷ Sign Up
South Korea	20200110711	ＩＩ형 항-ＣＤ20 항체와 선택적 ＢＣＬ-2 억제제와의 병용 치료요법 (-20 -2 COMBINATION THERAPY OF A TYPE II ANTI-CD20 ANTIBODY WITH A SELECTIVE BCL-2 INHIBITOR)	⤷ Sign Up
Israel	286036	שיטה להכנת 2-(1h-פירולו[2,3-b]פירידין-5-אלוקסי)-4-(4-((9-(4-כלורופניל)-3-(1,3-דיפלואורופרופאן-2- איל)-3-אזאספירו[5.5]-אונדק-8-en-8-yl)מתיל)פיפרזין- 1 איל )חומצה בנזואית (Process for preparing 2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)-4-(4-((9-(4-chlorophenyl)-3-(1,3-difluoropropan-2-yl)-3-azaspiro[5.5]undec-8-en-8-yl)methyl)piperazin-1-yl)benzoic acid)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for venetoclax

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435432	300873	Netherlands	⤷ Sign Up	PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207
2435432	2017/023	Ireland	⤷ Sign Up	PRODUCT NAME: VENETOCLAX (VENCLYXTO); REGISTRATION NO/DATE: EU/1/16/1138 20161205
2435432	SPC/GB17/032	United Kingdom	⤷ Sign Up	PRODUCT NAME: VENETOCLAX; REGISTERED: UK EU/1/16/1138 (NI) 20161207; UK PLGB 41042/0035 20161207; UK PLGB 41042/0036 20161207; UK PLGB 41042/0037 20161207
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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