Viewing data from:

BEQALZI

NDA

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

2 trials from ClinicalTrials.gov — 1 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
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

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

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)

Sort:

#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
NCENewly listed — daily FDA feed, not yet in monthly Orange Book edition	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

Change History (4)

Recent changes detected for this application.

ADDED7/14/2026

BEQALZI (sonrotoclax) received new chemical entity exclusivity expiring May 2031.

New: BEQALZI (SONROTOCLAX) — exclusivity NCE exp 05/13/2031

ADDED7/14/2026

Beqalzi (sonrotoclax) received new chemical entity exclusivity expiring May 2031.

New: BEQALZI (SONROTOCLAX) — exclusivity NCE exp 05/13/2031

ADDED7/14/2026

BEQALZI (sonrotoclax) received new chemical entity exclusivity expiring May 2031.

New: BEQALZI (SONROTOCLAX) — exclusivity NCE exp 05/13/2031

ADDED7/14/2026

Sonrotoclax (Beqalzi) received new chemical entity exclusivity protection expiring May 2031.

New: BEQALZI (SONROTOCLAX) — exclusivity NCE exp 05/13/2031