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SONROTOCLAX | N220711 | BEONE MEDICINES USA INC

4 strengths1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

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Today

11420968

Apr. 29, 2039

NCE

May. 13, 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

26 trials from ClinicalTrials.gov — 22 recruiting, 4 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia NCT06637501	Phase 2	Active	BeOne Medicines	94	2024-11-14 → 2029-09
Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies NCT04883957	Phase 1	Active	BeiGene	64	2021-07-05 → 2026-08-31
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
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
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
Sonrotoclax, Glofitamab, Gemcitabine, and Oxaliplatin for Relapsed or Refractory Large B-Cell Lymphoma NCT07774234	Phase 2	Not Yet Recruiting	The First Affiliated Hospital of Soochow University	39	2026-08-20 → 2030-08-20
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia NCT07770698	Phase 1/2	Not Yet Recruiting	BeOne Medicines	30	2026-10 → 2031-09
Pola-R-CHP Plus Sonrotoclax in Untreated BCL2-High/Double-Hit LBCL NCT07638787	Phase 1/2	Not Yet Recruiting	Ruijin Hospital	40	2026-06-15 → 2029-04-30
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
Sonrotoclax and BCMA Bispecific Antibody in Newly Diagnosed Systemic AL Amyloidosis Based on t(11;14) Genetic Stratification NCT07687004	Phase 1/2	Not Yet Recruiting	Institute of Hematology & Blood Diseases Hospital, China	50	2026-08-01 → 2029-08-01

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 15, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#001 — 1MG

RLD

1 patent1 exclusivity▴

TABLET;ORAL | Approved: May 13, 2026

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11420968	Apr 29, 2039	—	Yes	Yes	—	—

Exclusivities (1)

Code	Date	Status
NCE	May 13, 2031	Active

#002 — 5MG

RLD

1 patent1 exclusivity▾

TABLET;ORAL | Approved: May 13, 2026

#003 — 20MG

RLD

1 patent1 exclusivity▾

TABLET;ORAL | Approved: May 13, 2026

#004 — 80MG

RLD

1 patent1 exclusivity▾

TABLET;ORAL | Approved: May 13, 2026