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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

2037

2038

2039

2040

2041

2042

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

12 trials from ClinicalTrials.gov — 8 recruiting, 4 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Zanubrutinib in Combination With R-PolaCHP (ZaR-PolaCHP) for Newly Diagnosed Diffuse Large B-Cell Lymphoma NCT04850495	Phase 1	Active	Yazeed Sawalha	38	2021-11-16 → 2026-12-15
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 Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)NCT06073821	Phase 3	Active	BeOne Medicines	652	2023-11-11 → 2032-12
Tazemetostat in Combination With Zanubrutinib and Anti-CD20 Monoclonal Antibody in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma NCT06824701	Phase 1	Active	University of Utah	24	2025-09-12 → 2033-01
Zanubrutinib Induction Followed by Delayed Fixed-Duration Combination With Sonrotoclax for CLL/SLL：Stop Trial 2.0 NCT07682415	Phase 2	Not Yet Recruiting	Yi Shuhua	60	2026-06-08 → 2034-08-01
A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia NCT07674810	Phase 2	Not Yet Recruiting	M.D. Anderson Cancer Center	40	2026-12-31 → 2029-04-30
A Study of MRD-Guided Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk CLL/SLL Patients NCT07671378	Phase 2	Recruiting	The First Affiliated Hospital with Nanjing Medical University	24	2026-06-01 → 2030-12-31
Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma NCT05976763	Phase 3	Recruiting	Alliance for Clinical Trials in Oncology	421	2023-10-20 → 2038-08-31
Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL NCT07321652	Phase 3	Recruiting	Alliance for Clinical Trials in Oncology	466	2026-04-30 → 2038-09-30
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma NCT04840602	Phase 2	Recruiting	National Cancer Institute (NCI)	92	2022-01-05 → 2028-03-31

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

Medicare Part D Spending

CMS annual spending data for Brukinsa (2023)

Total Spending

$801.4M

Total Claims

59,762

Beneficiaries

9,470

Avg Cost/Unit

$122.42

Spending Trend

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

YoY Change:+4.5%

5yr CAGR:+3.6%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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