Trial #	Patent	Type	Petitioner	Status	Filed	Decision
PGR2022-00023	10993942	PGR	Dr. Reddy's Laboratories, Inc. et al.	Final Written Decision	2022-02-03	2025-01-30
IPR2023-00052	11110087	IPR	Dr. Reddy's Laboratories, Inc. et al.	Final Written Decision	2022-10-14	2025-01-30

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AbbVie Inc. et al v. Alembic Pharmaceuticals Ltd. et al 1:2020cv01009	D. Del.	2020-07-28	Terminated 2024-12-17	—
ABBVIE INC. et al v. DR. REDDY'S LABORATORIES, INC. 3:2020cv09292 4 patentsANDA 214733venetoclax	D.N.J.	2020-07-22	Terminated 2020-08-28	—
AbbVie Inc. et al v. Dr. Reddys Laboratories, Ltd. et al 1:2020cv00968	D. Del.	2020-07-21	Terminated 2024-12-17	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

119 trials from ClinicalTrials.gov — 41 recruiting, 29 active, 32 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma NCT05951959	Phase 2	Active	AstraZeneca	108	2023-12-13 → 2028-10-31
A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma NCT04416451	Phase 2	Active	Memorial Sloan Kettering Cancer Center	6	2021-05-04 → 2027-06
Atezolizumab, Obinutuzumab, and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Relapsed or Refractory Richter Syndrome NCT02846623	Phase 2	Active	M.D. Anderson Cancer Center	50	2017-01-31 → 2027-02-28
Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma NCT03946878	Phase 2	Active	M.D. Anderson Cancer Center	32	2019-08-13 → 2028-02-08
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 NCT05753501	Phase 1	Active	AbbVie	135	2023-06-09 → 2031-03
Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL NCT03319901	Phase 1/2	Active	Dana-Farber Cancer Institute	82	2017-10-30 → 2028-05-30
The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL)NCT04447768	Phase 2	Active	Memorial Sloan Kettering Cancer Center	100	2020-12-03 → 2027-07
Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax NCT04419519	Phase 2	Active	Memorial Sloan Kettering Cancer Center	81	2020-05-13 → 2027-05
Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL NCT03580928	Phase 2	Active	Dana-Farber Cancer Institute	72	2018-08-07 → 2027-12-31
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial NCT03844048	Phase 3	Active	AbbVie	165	2019-09-06 → 2027-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 16 NDCs (8 FSS, 8 Big4)

Lowest Price

$19.35

Highest Price

$14129.21

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00074-0561-11VENCLEXTA 10MG TAB	$19.35	Big4	Abbvie US LLC	07/31/2030
00074-0561-11VENCLEXTA 10MG TAB	$23.54	FSS	Abbvie US LLC	07/31/2030
00074-0561-14VENCLEXTA 10MG TAB	$130.43	Big4	Abbvie US LLC	07/31/2030
00074-0561-14VENCLEXTA 10MG TAB	$164.83	FSS	Abbvie US LLC	07/31/2030
00074-0566-07VENCLEXTA 50MG TAB	$323.40	Big4	Abbvie US LLC	07/31/2030
00074-0566-07VENCLEXTA 50MG TAB	$412.11	FSS	Abbvie US LLC	07/31/2030

Showing 6 of 16 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Venclexta (2024)

Total Spending

$941.7M

Total Claims

107,871

Beneficiaries

21,868

Avg Cost/Unit

$116.48

Spending Trend

$342.7M(2019)→$562.1M(2020)→$691.0M(2021)→$757.6M(2022)→$814.7M(2023)→$941.7M(2024)

YoY Change:-1.8%

5yr CAGR:+4.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs

9 active API suppliers hold Drug Master Files for this ingredient.

PORTON PHARMA SOLUTIONS LTDVENETOCLAX

DMF 417102025

DR REDDYS LABORATORIES LTDVENETOCLAX

DMF 336692019

MSN LABORATORIES PRIVATE LTDVENETOCLAX

DMF 340222019

ALEMBIC PHARMACEUTICALS LTDVENETOCLAX

DMF 341402019

XUZHOU WANBANG JINQIAO PHARMA CO LTDVENETOCLAX

DMF 430062025

CHANGZHOU PHARMACEUTICAL FACTORYVENETOCLAX

DMF 392892023

HETERO LABS LTDVENETOCLAX

DMF 402692024

NATCO PHARMA LTDVENETOCLAX

DMF 407202024

CHENGDA PHARMACEUTICALS CO LTDVENETOCLAX INTERMEDIATE (CAS NO.:1628047-87-9)

DMF 431432025

CHENGDA PHARMACEUTICALS CO LTDVENETOCLAX INTERMEDIATE (CAS NO.:1228779-96-1)

DMF 431442025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

20 letters from Drugs@FDA

Date	Submission	Document
May 26, 2026	SUPPL -32	View Letter (PDF)
Feb 23, 2026	SUPPL -31	View Letter (PDF)
Jun 16, 2022	SUPPL -27	View Letter (PDF)
Oct 25, 2021	SUPPL -26	View Letter (PDF)
Oct 6, 2021	SUPPL -24	View Letter (PDF)
Nov 20, 2020	SUPPL -23	View Letter (PDF)
Oct 20, 2020	SUPPL -20	View Letter (PDF)
Oct 20, 2020	SUPPL -21	View Letter (PDF)
Jun 15, 2020	SUPPL -17	View Letter (PDF)
Jun 2, 2020	SUPPL -18	View Letter (PDF)
Jul 26, 2019	SUPPL -11	View Letter (PDF)
Jul 26, 2019	SUPPL -15	View Letter (PDF)
Jul 26, 2019	SUPPL -14	View Letter (PDF)
May 16, 2019	SUPPL -13	View Letter (PDF)
Dec 12, 2018	SUPPL -9	View Letter (PDF)
Sep 12, 2018	SUPPL -7	View Letter (PDF)
Sep 12, 2018	SUPPL -10	View Letter (PDF)
Jun 14, 2018	SUPPL -4	View Letter (PDF)
Jun 14, 2018	SUPPL -5	View Letter (PDF)
Apr 11, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG

RLDAB

14 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 11, 2016

Patents (14)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8546399	Jun 27, 2031	—	Yes	Yes	—	—
8722657	Jan 29, 2032	—	Yes	—	—	—
9174982	May 26, 2030	—	—	—		—
9174982	May 26, 2030	—	—	—		—
9174982	May 26, 2030	—	—	—		—
9174982	May 26, 2030	—	—	—		—
9539251	Sep 6, 2033	—	—	—		—
10730873	Nov 21, 2031	—	Yes	—	—	—
10993942	Sep 6, 2033	—	—	—		—
11110087	Sep 6, 2033	—	—	—		—
11110087	Sep 6, 2033	—	—	—		—
11369599	May 23, 2032	—	—	Yes	—	—
11413282	Sep 6, 2033	—	—	—		—
11590128	Sep 6, 2033	—	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-239	May 15, 2026	Expired

#002 — 50MG

RLDAB

14 patents1 exclusivity▾

TABLET;ORAL | Approved: Apr 11, 2016

#003 — 100MG

RLDAB

14 patents1 exclusivity▾

TABLET;ORAL | Approved: Apr 11, 2016