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BRUKINSA

NDA

ZANUBRUTINIB | N213217 | BEONE MEDICINES USA INC

1 strength12 unique patents7 unique exclusivities

Patent Timeline

12 unique patents, 7 exclusivities by expiration date

Active (12)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

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2038

2039

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2041

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2043

Today

Apr. 22, 2034

Apr. 22, 2034

Aug. 15, 2037

Apr. 22, 2034

Aug. 15, 2037

Jun. 24, 2039

Jan. 19, 2043

Aug. 15, 2037

Aug. 15, 2037

Jan. 19, 2043

Jan. 19, 2043

Aug. 15, 2037

I-817

Jan. 19, 2026

ODE-276

Nov. 14, 2026

I-936

Mar. 7, 2027

ODE-371

Aug. 31, 2028

ODE-370

Sep. 14, 2028

ODE-274

Jan. 19, 2030

ODE-467

Mar. 7, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Pharmacyclics LLC v. BeOne Medicines USA, Inc. et al 1:2023cv00646 6 patentsibrutinib (IMBRUVICA®); zanubrutinib (BRUKINSA®)	D. Del.	2023-06-13	Terminated 2025-09-30	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

26 trials from ClinicalTrials.gov — 2 recruiting, 4 active, 18 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL NCT03336333	Phase 3	Active	BeiGene	590	2017-10-31 → 2027-10-31
Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies NCT04170283	Phase 3	Active	BeiGene	955	2020-01-16 → 2028-12
A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation NCT04002297	Phase 3	Active	BeOne Medicines	510	2019-08-20 → 2031-09-30
Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies NCT04277637	Phase 1	Active	BeOne Medicines	437	2020-03-24 → 2027-05-31
Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)NCT03824483	Phase 2	Recruiting	Memorial Sloan Kettering Cancer Center	230	2019-02-22 → 2027-02
Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment with or Without Sonrotoclax for Patients with Richter Transformation NCT04271956	Phase 2	Recruiting	German CLL Study Group	83	2020-02-19 → 2026-08
Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab NCT04282018	Phase 1/2	Completed	BeiGene	97	2020-04-29 → 2024-08-28
BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)NCT03520920	Phase 2	Completed	BeiGene	41	2018-01-04 → 2020-08-28
Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)NCT03206970	Phase 2	Completed	BeiGene	86	2017-03-02 → 2020-09-08
Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies NCT04172246	Phase 1/2	Completed	BeiGene	55	2020-01-29 → 2025-06-30

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$9902.59

Highest Price

$13320.49

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
72579-0011-02BRUKINSA 80MG CAP,ORAL	$13320.49	FSS	BeOne Medicines USA, Inc.	08/01/2027
72579-0011-02BRUKINSA 80MG CAP,ORAL	$9902.59	Big4	BeOne Medicines USA, Inc.	08/01/2027

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

Medicare Part D Spending

CMS annual spending data for Brukinsa (2024)

Total Spending

$1.7B

Total Claims

130,764

Beneficiaries

18,031

Avg Cost/Unit

$121.31

Spending Trend

$12.5M(2020)→$82.6M(2021)→$303.3M(2022)→$801.4M(2023)→$1.7B(2024)

YoY Change:-0.9%

5yr CAGR:+2.5%

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

API Supply Chain3 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LABORATORIES PRIVATE LTDZANUBRUTINIB

DMF 382152023

OLON SPAZANUBRUTINIB

DMF 383502023

MSN LABORATORIES PRIVATE LTDZANUBRUTINIB (FORM-A)

DMF 396652024

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -15	View Letter (PDF)
Jul 2, 2024	SUPPL -14	View Letter (PDF)
Mar 8, 2024	SUPPL -11	View Letter (PDF)
Dec 22, 2023	SUPPL -9	View Letter (PDF)
Apr 24, 2023	SUPPL -10	View Letter (PDF)
Jan 20, 2023	SUPPL -7	View Letter (PDF)
Sep 20, 2021	SUPPL -5	View Letter (PDF)
Sep 1, 2021	SUPPL -4	View Letter (PDF)
Nov 15, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 80MG

RLD

12 patents7 exclusivities▴

CAPSULE;ORAL | Approved: Nov 14, 2019

Patents (12) · 66 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9447106	Apr 22, 2034	—	Yes	Yes		—
10570139	Apr 22, 2034	—	—	—		—
10927117	Aug 15, 2037	—	Yes	Yes	—	—
11142528	Apr 22, 2034	—	—	Yes		—
11591340	Aug 15, 2037	—	—	—		—
11701357	Jun 24, 2039	—	—	—		—
11786531	Jan 19, 2043	—	—	—		—
11851437	Aug 15, 2037	—	Yes	Yes	—	—
11884674	Aug 15, 2037	—	—	—		—
11896596	Jan 19, 2043	—	—	—		—
11911386	Jan 19, 2043	—	—	—		—
11970500	Aug 15, 2037	—	—	—		—

Exclusivities (7)

Code	Date	Status
I-817	Jan 19, 2026	Expired
I-936	Mar 7, 2027	< 1 year
ODE-274	Jan 19, 2030	Active
ODE-276	Nov 14, 2026	< 1 year
ODE-370	Sep 14, 2028	Active
ODE-371	Aug 31, 2028	Active
ODE-467	Mar 7, 2031	Active