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Generic Venclexta Availability

Last updated on Sep 8, 2021.

Venclexta is a brand name of venetoclax, approved by the FDA in the following formulation(s):

VENCLEXTA (venetoclax - tablet;oral)

  • Manufacturer: ABBVIE INC
    Approval date: April 11, 2016
    Strength(s): 10MG [RLD], 50MG [RLD], 100MG [RLD]

Has a generic version of Venclexta been approved?

No. There is currently no therapeutically equivalent version of Venclexta available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Venclexta. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Patent 10,730,873

    Patent expiration dates:

    • November 21, 2031
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      Drug substance
  • Patent 10,993,942

    Patent expiration dates:

    • September 6, 2033
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
  • Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases
    Patent 8,546,399
    Issued: October 1, 2013
    Assignee(s): Abbvie Inc.

    Disclosed are compounds which inhibit the activity of anti-apoptotic Bcl-2 proteins, compositions containing the compounds and methods of treating diseases during which is expressed anti-apoptotic Bcl-2 protein.

    Patent expiration dates:

    • June 27, 2031
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Salts and crystalline forms of an apoptosis-inducing agent
    Patent 8,722,657
    Issued: May 13, 2014
    Assignee(s): Abbvie Inc.

    Salts and crystalline forms of 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}-sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide are suitable active pharmaceutical ingredients for pharmaceutical compositions useful in treatment of a disease characterized by overexpression of one or more anti-apoptotic Bcl-2 family proteins, for example cancer.

    Patent expiration dates:

    • January 29, 2032
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      Drug substance
  • Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases
    Patent 9,174,982
    Issued: November 3, 2015
    Assignee(s): ABBVIE INC. GENENTECH, INC. THE WALTER AND ELIZA HALL INSTITUTE OF MEDICAL RESEARCH

    Disclosed are compounds which inhibit the activity of anti-apoptotic Bcl-2 proteins, compositions containing the compounds and methods of treating diseases during which is expressed anti-apoptotic Bcl-2 protein.

    Patent expiration dates:

    • May 26, 2030
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      Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
    • May 26, 2030
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      Patent use: TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
    • May 26, 2030
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      Patent use: TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
    • May 26, 2030
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
  • Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor
    Patent 9,539,251
    Issued: January 10, 2017
    Assignee(s): Genentech, Inc. F. Hoffmann-La Roche AG

    The present invention is directed to a combination therapy involving a type II anti-CD20 antibody and a selective Bcl-2 inhibitor for the treatment of a patient suffering from cancer, particularly, a CD20-expressing cancer.

    Patent expiration dates:

    • September 6, 2033
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      Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • April 11, 2021 - NEW CHEMICAL ENTITY
    • June 8, 2021 - INFORMATION ADDED TO THE PACKAGE INSERT REGARDING THE REVISION OF THE MONOTHERAPY INDICATION OF VENETOCLAX
    • June 8, 2021 - REVISIONS TO INDICATION FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
    • November 21, 2021 - VENETOCLAX IN COMBO WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
    • May 15, 2022 - VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA
    • April 11, 2023 -
    • October 16, 2023 - REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2
    • June 8, 2025 -
    • November 21, 2025 -
    • May 15, 2026 -

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.