Venetoclax Patent Expiration

Venetoclax is Used for treating various forms of leukemia, particularly acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), in adults with certain conditions or as subsequent therapy. It was first introduced by Abbvie Inc in its drug Venclexta on Apr 11, 2016. 2 different companies have introduced drugs containing Venetoclax.


Venetoclax Patents

Given below is the list of patents protecting Venetoclax, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Venclexta US10993942 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor Sep 06, 2033 Abbvie
Venclexta US11110087 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor Sep 06, 2033 Abbvie
Venclexta US11413282 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor Sep 06, 2033 Abbvie
Venclexta US11590128 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor Sep 06, 2033 Abbvie
Venclexta US9539251 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor Sep 06, 2033 Abbvie
Venclexta US11369599 Melt-extruded solid dispersions containing an apoptosis-inducing agent May 23, 2032 Abbvie
Venclexta US8722657 Salts and crystalline forms of an apoptosis-inducing agent Jan 29, 2032 Abbvie
Venclexta US10730873 Salts and crystalline forms of an apoptosis-inducing agent Nov 21, 2031 Abbvie
Venclexta US8546399 Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases Jun 27, 2031 Abbvie
Venclexta US9174982 Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases May 26, 2030 Abbvie



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Venetoclax's patents.

Given below is the list recent legal activities going on the following patents of Venetoclax.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 21 Jan, 2026 US11413282
Payment of Maintenance Fee, 4th Year, Large Entity 13 Nov, 2025 US11369599
Payment of Maintenance Fee, 12th Year, Large Entity 09 Oct, 2025 US8722657
Appeal to Court of Appeals 26 Sep, 2025 US11369599
Court Processing Terminated 29 Jul, 2025 US11369599
Decision in Civil Action - Dismissed by Court 29 Jul, 2025 US11369599
Email Notification 15 Mar, 2025 US11369599
Payment of Maintenance Fee, 12th Year, Large Entity 13 Mar, 2025 US8546399
Review Certificate Mailed 24 Feb, 2025 US11110087
Review Certificate Mailed 07 Feb, 2025 US10993942


Venetoclax's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Venetoclax:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Early Clonal Dynamics During Venetoclax Treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) National Heart, Lung, and Blood Institute (NHLBI) NA RECRUITING
(Sep 18, 2026)
PHASE2
Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) Taiho Oncology, Inc. NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia Hoffmann-La Roche NA RECRUITING
(Sep 1, 2026)
PHASE1
Administration of Venetoclax to Promote Apoptosis of HIV-infected Cells and Reduce the Size of the HIV Reservoir Among People Living With HIV on ART University of Aarhus NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010). Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE3
Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML Ryvu Therapeutics SA NA RECRUITING
(Sep 1, 2026)
PHASE2
A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE1
Study to Assess Change in Disease Activity of Oral Venetoclax in Adult Participants With Recurring Relapsed or Refractory (R/R) Waldenström Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL) AbbVie NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) AbbVie NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome M.D. Anderson Cancer Center NA TERMINATED
(Aug 1, 2026)
PHASE1, PHASE2
Atezolizumab, Obinutuzumab, and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Relapsed or Refractory Richter Syndrome M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma AbbVie NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Sequential Regimen of Bendamustine Followed by Obinutuzumab (GA101), Zanubrutinib (BGB-3111) and Venetoclax (ABT-199) in Patients With Relapsed/Refractory CLL German CLL Study Group NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Venetoclax After TKI to Target Persisting Stem Cells in CML Thomas Ernst, PD Dr. med. NA COMPLETED
(Aug 1, 2026)
PHASE2
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies AbbVie NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL) BeOne Medicines NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE1
Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies Nurix Therapeutics, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive MRD M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE2
Phase 1/2 FLAG-IDA, VEN and Asciminib in CML and Ph+ AML M.D. Anderson Cancer Center NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Venetoclax Plus Zanubrutinib for the Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Kerry Rogers NA RECRUITING
(Aug 1, 2026)
PHASE2
Venetoclax, Chidamide, and Chiglitazar Sodium (VCC) in Patients With Relapsed/Refractory Acute Myeloid Leukemia The First Affiliated Hospital of Xiamen University NA RECRUITING
(Aug 1, 2026)
PHASE2
Venetoclax Add in Combination With Fludarabine, Cyratabine and Idarubicine in Induction for Acute Myelid Leukemia Gruppo Italiano Malattie EMatologiche dell'Adulto NA COMPLETED
(Jul 1, 2026)
PHASE2
Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia ECOG-ACRIN Cancer Research Group NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL) Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma Chinese PLA General Hospital NA RECRUITING
(Jul 1, 2026)
PHASE2
A Study of Lonitoclax (ZE50-0134) in Relapsed or Refractory B-cell Malignancies Lomond Therapeutics Holdings, Inc. NA RECRUITING
(Jul 1, 2026)
PHASE1
Nemtabrutinib With Venetoclax and Obinutuzumab in Patients With Chronic Lymphocytic Leukemia Medical College of Wisconsin NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
TLN-499 in Combination With Venetoclax in Patients With Relapsed/Refractory Solid Tumors Treeline Biosciences, Inc. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study National Cancer Institute (NCI) NA RECRUITING
(Jun 1, 2026)
PHASE3
Phase II Trial of Venetoclax and Rituximab as Initial Therapy in Older Patients With Mantle Cell Lymphoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins NA TERMINATED
(Jun 1, 2026)
PHASE2
Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia Vanderbilt-Ingram Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE1
A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia M.D. Anderson Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE1
Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients French Innovative Leukemia Organisation NA RECRUITING
(Jun 1, 2026)
PHASE2
A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10) Dizal Pharmaceuticals NA RECRUITING
(Jun 1, 2026)
PHASE2
Nemtabrutinib and Venetoclax for the Treatment of Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Jennifer Woyach NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial AbbVie NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma Emory University NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Proof of Concept Pilot Study of the Addition of Venetoclax to Standard Remission Induction Chemotherapy Fludarabine or Cladrabine, Cytarabine, and Granulocyte Colony Stimulating Factor (G-CSF) (FLAG or CLAG) for Frontline Therapy of Secondary Acute Myeloid Leukemia University of Michigan Rogel Cancer Center NA TERMINATED
(May 1, 2026)
PHASE2
A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL Georgetown University NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Copanlisib and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma City of Hope Medical Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial University of Utah NA RECRUITING
(Apr 1, 2026)
PHASE2
A Phase II Study of the Combination of Ponatinib With Mini-hyper CVD Chemotherapy and Venetoclax in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia M.D. Anderson Cancer Center NA TERMINATED
(Apr 1, 2026)
PHASE2
Inhibiting the Anti-apoptotic Factor, BCL-2, at the Time of ART Initiation to Promote Apoptosis of HIV-infected Cells and Restrict the Seeding of the HIV Reservoir (The INITIATE Study) Thomas Aagaard Rasmussen NA RECRUITING
(Apr 1, 2026)
PHASE1
A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML MEI Pharma, Inc. NA TERMINATED
(Mar 1, 2026)
PHASE1
Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia (AML) University of Illinois at Chicago NA COMPLETED
(Mar 1, 2026)
PHASE1
Front-line VenObi Combination Followed by Ven or VenZan Combination in Patients With Residual Disease: a MRD Tailored Treatment for Young Patients With High-risk CLL Gruppo Italiano Malattie EMatologiche dell'Adulto NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma Gottfried von Keudell, MD PhD NA RECRUITING
(Mar 1, 2026)
PHASE2
A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML Servier Bio-Innovation LLC NA TERMINATED
(Mar 1, 2026)
PHASE1, PHASE2
A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL) BeOne Medicines NA RECRUITING
(Mar 1, 2026)
PHASE3
Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (VENP-A-QUI) PETHEMA Foundation NA RECRUITING
(Mar 1, 2026)
PHASE3


Venetoclax Generic API Manufacturers

Several generic applications have been filed for Venetoclax.

Given below is the list of companies who have filed for Venetoclax generic, along with the locations of their manufacturing plants worldwide.


Venetoclax News

India's Pharmaceutical Industry at a Turning Point: Balancing Generic Strength with the Push for Innovation - Whalesbook

18 Feb, 2026

Will India always remain focused solely on generics? - Down To Earth

18 Feb, 2026

Budget 2026-27: Government reduces customs duties on 17 medications to alleviate financial strain for cancer patients.

01 Feb, 2026

Patent denial for multinational corporation's cancer medication; generics expected to launch in the market - The Economic Times

23 Jan, 2026

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