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 43 .
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 2026-09-14 22:38:34 2026-08 N218785-001 BRUKINSA 160MG TABLET / ORAL RLD, RS 2025-06-10 84e616aacf4f…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 11 · 414 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N218785-001 10570139 2034-04-22 U-1745 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 10570139 2034-04-22 U-3860 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 10570139 2034-04-22 U-3486 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 10570139 2034-04-22 U-3063 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 10570139 2034-04-22 U-2666 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 10570139 2034-04-22 U-2537 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 10570139 2034-04-22 U-2145 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11142528 2034-04-22 U-1745 Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11142528 2034-04-22 U-3860 Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11142528 2034-04-22 U-3486 Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11142528 2034-04-22 U-3063 Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11142528 2034-04-22 U-2666 Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11142528 2034-04-22 U-2537 Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11142528 2034-04-22 U-2145 Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 9447106 2034-04-22 U-1745 Drug substance, Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 9447106 2034-04-22 U-2145 Drug substance, Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 9447106 2034-04-22 U-2537 Drug substance, Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 9447106 2034-04-22 U-2666 Drug substance, Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 9447106 2034-04-22 U-3063 Drug substance, Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 9447106 2034-04-22 U-3486 Drug substance, Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 9447106 2034-04-22 U-3860 Drug substance, Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 10927117 2037-08-15 Drug substance, Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11591340 2037-08-15 U-3728 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11591340 2037-08-15 U-3727 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11591340 2037-08-15 U-3486 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11591340 2037-08-15 U-3063 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11591340 2037-08-15 U-2666 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11591340 2037-08-15 U-2537 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11591340 2037-08-15 U-2145 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11591340 2037-08-15 U-1745 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11591340 2037-08-15 U-3729 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11851437 2037-08-15 Drug substance, Drug product 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11884674 2037-08-15 U-1745 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11884674 2037-08-15 U-3860 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11884674 2037-08-15 U-3486 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11884674 2037-08-15 U-3063 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11884674 2037-08-15 U-2666 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11884674 2037-08-15 U-2537 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11884674 2037-08-15 U-2145 2025-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218785-001 11970500 2037-08-15 U-1745 2025-06-30 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 42 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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