Home Applications 218785 Application 218785
Type NDA
Sponsor BEONE MEDICINES USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BRUKINSA ZANUBRUTINIB TABLET;ORAL 160MG Yes Yes 002 BRUKINSA ZANUBRUTINIB CAPSULE; ORAL 80MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218785-001 BRUKINSA ZANUBRUTINIB 160MG TABLET / ORAL RLD, RS 2025-06-10
Orange Book patents# Current patent rows page 1 of 1 · 69 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218785-001 10570139 2034-04-22 U-1745 2025-06-30 N218785-001 10570139 2034-04-22 U-2145 2025-06-30 N218785-001 10570139 2034-04-22 U-2537 2025-06-30 N218785-001 10570139 2034-04-22 U-2666 2025-06-30 N218785-001 10570139 2034-04-22 U-3063 2025-06-30 N218785-001 10570139 2034-04-22 U-3486 2025-06-30 N218785-001 10570139 2034-04-22 U-3860 2025-06-30 N218785-001 11142528 2034-04-22 U-1745 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-2145 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-2537 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-2666 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-3063 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-3486 Drug product 2025-06-30 N218785-001 11142528 2034-04-22 U-3860 Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-1745 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-2145 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-2537 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-2666 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-3063 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-3486 Drug substance, Drug product 2025-06-30 N218785-001 9447106 2034-04-22 U-3860 Drug substance, Drug product 2025-06-30 N218785-001 10927117 2037-08-15 Drug substance, Drug product 2025-06-30 N218785-001 11591340 2037-08-15 U-1745 2025-06-30 N218785-001 11591340 2037-08-15 U-2145 2025-06-30 N218785-001 11591340 2037-08-15 U-2537 2025-06-30 N218785-001 11591340 2037-08-15 U-2666 2025-06-30 N218785-001 11591340 2037-08-15 U-3063 2025-06-30 N218785-001 11591340 2037-08-15 U-3486 2025-06-30 N218785-001 11591340 2037-08-15 U-3727 2025-06-30 N218785-001 11591340 2037-08-15 U-3728 2025-06-30 N218785-001 11591340 2037-08-15 U-3729 2025-06-30 N218785-001 11851437 2037-08-15 Drug substance, Drug product 2025-06-30 N218785-001 11884674 2037-08-15 U-1745 2025-06-30 N218785-001 11884674 2037-08-15 U-2145 2025-06-30 N218785-001 11884674 2037-08-15 U-2537 2025-06-30 N218785-001 11884674 2037-08-15 U-2666 2025-06-30 N218785-001 11884674 2037-08-15 U-3063 2025-06-30 N218785-001 11884674 2037-08-15 U-3486 2025-06-30 N218785-001 11884674 2037-08-15 U-3860 2025-06-30 N218785-001 11970500 2037-08-15 U-1745 2025-06-30 N218785-001 11970500 2037-08-15 U-2145 2025-06-30 N218785-001 11970500 2037-08-15 U-2537 2025-06-30 N218785-001 11970500 2037-08-15 U-2666 2025-06-30 N218785-001 11970500 2037-08-15 U-3063 2025-06-30 N218785-001 11970500 2037-08-15 U-3486 2025-06-30 N218785-001 11970500 2037-08-15 U-3860 2025-06-30 N218785-001 11701357 2039-06-24 U-3860 2025-06-30 N218785-001 12233069 2040-06-10 Drug product 2025-06-30 N218785-001 11786531 2043-01-19 U-3715 2025-06-30 N218785-001 11786531 2043-01-19 U-3716 2025-06-30 N218785-001 11786531 2043-01-19 U-3717 2025-06-30 N218785-001 11786531 2043-01-19 U-3718 2025-06-30 N218785-001 11786531 2043-01-19 U-3719 2025-06-30 N218785-001 11786531 2043-01-19 U-3720 2025-06-30 N218785-001 11786531 2043-01-19 U-3875 2025-06-30 N218785-001 11896596 2043-01-19 U-3715 2025-06-30 N218785-001 11896596 2043-01-19 U-3716 2025-06-30 N218785-001 11896596 2043-01-19 U-3717 2025-06-30 N218785-001 11896596 2043-01-19 U-3718 2025-06-30 N218785-001 11896596 2043-01-19 U-3719 2025-06-30 N218785-001 11896596 2043-01-19 U-3720 2025-06-30 N218785-001 11896596 2043-01-19 U-3875 2025-06-30 N218785-001 11911386 2043-01-19 U-3715 2025-06-30 N218785-001 11911386 2043-01-19 U-3716 2025-06-30 N218785-001 11911386 2043-01-19 U-3717 2025-06-30 N218785-001 11911386 2043-01-19 U-3718 2025-06-30 N218785-001 11911386 2043-01-19 U-3719 2025-06-30 N218785-001 11911386 2043-01-19 U-3720 2025-06-30 N218785-001 11911386 2043-01-19 U-3875 2025-06-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 7 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N218785-001 BRUKINSA 160MG TABLET / ORAL RLD, RS 2025-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218785-001 BRUKINSA 160MG TABLET / ORAL RLD, RS 2025-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218785-001 BRUKINSA 160MG TABLET / ORAL RLD, RS 2025-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218785-001 BRUKINSA 160MG TABLET / ORAL RLD, RS 2025-06-10 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218785-001 BRUKINSA 160MG TABLET / ORAL RLD, RS 2025-06-10 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 9 · 345 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N218785-001 10570139 2034-04-22 U-1745 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 10570139 2034-04-22 U-3860 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 10570139 2034-04-22 U-3486 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 10570139 2034-04-22 U-3063 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 10570139 2034-04-22 U-2666 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 10570139 2034-04-22 U-2537 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 10570139 2034-04-22 U-2145 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11142528 2034-04-22 U-1745 Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11142528 2034-04-22 U-3860 Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11142528 2034-04-22 U-3486 Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11142528 2034-04-22 U-3063 Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11142528 2034-04-22 U-2666 Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11142528 2034-04-22 U-2537 Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11142528 2034-04-22 U-2145 Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 9447106 2034-04-22 U-1745 Drug substance, Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 9447106 2034-04-22 U-2145 Drug substance, Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 9447106 2034-04-22 U-2537 Drug substance, Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 9447106 2034-04-22 U-2666 Drug substance, Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 9447106 2034-04-22 U-3063 Drug substance, Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 9447106 2034-04-22 U-3486 Drug substance, Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 9447106 2034-04-22 U-3860 Drug substance, Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 10927117 2037-08-15 Drug substance, Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11591340 2037-08-15 U-3728 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11591340 2037-08-15 U-3727 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11591340 2037-08-15 U-3486 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11591340 2037-08-15 U-3063 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11591340 2037-08-15 U-2666 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11591340 2037-08-15 U-2537 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11591340 2037-08-15 U-2145 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11591340 2037-08-15 U-1745 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11591340 2037-08-15 U-3729 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11851437 2037-08-15 Drug substance, Drug product 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11884674 2037-08-15 U-1745 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11884674 2037-08-15 U-3860 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11884674 2037-08-15 U-3486 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11884674 2037-08-15 U-3063 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11884674 2037-08-15 U-2666 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11884674 2037-08-15 U-2537 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11884674 2037-08-15 U-2145 2025-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218785-001 11970500 2037-08-15 U-1745 2025-06-30 caaa826d4ba7…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BRUKINSA ZANUBRUTINIB BeOne Medicines USA, Inc. 3e08fe23-d70e-424c-bc51-1222e320f902 2026-07-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 218785 application number: NDA218785
Documents# Document, Submission type, Date table Document Submission type Date 82552 ORIG 2025-06-12 82550 ORIG 2025-06-12 82540 ORIG 2025-06-11 82539 ORIG 2025-06-11