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Last Updated: December 8, 2022

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 Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Venetoclax has two hundred and fifty-one 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
Loxo OncologyPhase 2
The Leukemia and Lymphoma SocietyPhase 2
Loxo Oncology, Inc.Phase 2

See all venetoclax clinical trials

Pharmacology for venetoclax
Drug ClassBCL-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 Inc VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-001 Apr 11, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-001 Apr 11, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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

Country Patent Number Title Estimated Expiration
Argentina 079124 AGENTES INDUCTORES DE APOPTOSIS PARA EL TRATAMIENTO DEL CANCER Y DE ENFERMEDADES INMUNES Y AUTOINMUNES See Plans and Pricing
New Zealand 610151 Salts and crystalline forms of an apoptosis-inducing agent See Plans and Pricing
Peru 20120345 DERIVADOS DE 2-(1H-PIRROLO[2,3-B]PIRIDIN-5-ILOXI)-N-FENILSULFONILBENZAMIDA COMO INHIBIDORES DE PROTEINAS ANTI-APOPTOTICAS See Plans and Pricing
San Marino T201500225 Agenti induttori di apaptosi per il trattamento del cancro e delle malattie immuni e autoimmuni See Plans and Pricing
South Korea 20180124164 암,면역 질환 및 자가면역 질환의 치료를 위한 아폽토시스-유도제 (- Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases) See Plans and Pricing
Hong Kong 1183866 治療癌症和免疫與自身免疫疾病的細胞程序死亡誘導藥劑 (APOPTOSIS-INDUCING AGENTS FOR THE TREATMENT OF CANCER AND IMMUNE AND AUTOIMMUNE DISEASES) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for venetoclax

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435432 1790021-8 Sweden See Plans and Pricing PRODUCT NAME: VENETOCLAX; REG. NO/DATE: EU/1/16/1138 20161207
2435432 300873 Netherlands See Plans and Pricing PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207
2435432 C02435432/01 Switzerland See Plans and Pricing PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66235 08.05.2018
2435432 122017000031 Germany See Plans and Pricing PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161205
2435432 693 Finland See Plans and Pricing
2435432 2017023 Norway See Plans and Pricing PRODUCT NAME: VENETOKLAKS, DVS. 4-(4-(2-(4-; REG. NO/DATE: EU/1/16/1138 20161213
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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