Home Applications 213217 Application 213217
Type NDA
Sponsor BEIGENE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BRUKINSA ZANUBRUTINIB CAPSULE;ORAL 80MG Yes Yes
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 N213217-001 BRUKINSA ZANUBRUTINIB 80MG CAPSULE / ORAL RLD 2019-11-14
Orange Book patents# Current patent rows page 1 of 1 · 68 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213217-001 10570139 2034-04-22 U-1745 2021-06-04 N213217-001 10570139 2034-04-22 U-2145 2021-06-04 N213217-001 10570139 2034-04-22 U-2537 2021-06-04 N213217-001 10570139 2034-04-22 U-2666 2021-06-04 N213217-001 10570139 2034-04-22 U-3063 2021-06-04 N213217-001 10570139 2034-04-22 U-3486 2021-06-04 N213217-001 10570139 2034-04-22 U-3860 2021-06-04 N213217-001 11142528 2034-04-22 U-1745 Drug product 2021-11-12 N213217-001 11142528 2034-04-22 U-2145 Drug product 2021-11-12 N213217-001 11142528 2034-04-22 U-2537 Drug product 2021-11-12 N213217-001 11142528 2034-04-22 U-2666 Drug product 2021-11-12 N213217-001 11142528 2034-04-22 U-3063 Drug product 2021-11-12 N213217-001 11142528 2034-04-22 U-3486 Drug product 2021-11-12 N213217-001 11142528 2034-04-22 U-3860 Drug product 2021-11-12 N213217-001 9447106 2034-04-22 U-1745 Drug substance, Drug product 2019-11-20 N213217-001 9447106 2034-04-22 U-2145 Drug substance, Drug product 2019-11-20 N213217-001 9447106 2034-04-22 U-2537 Drug substance, Drug product 2019-11-20 N213217-001 9447106 2034-04-22 U-2666 Drug substance, Drug product 2019-11-20 N213217-001 9447106 2034-04-22 U-3063 Drug substance, Drug product 2019-11-20 N213217-001 9447106 2034-04-22 U-3486 Drug substance, Drug product 2019-11-20 N213217-001 9447106 2034-04-22 U-3860 Drug substance, Drug product 2019-11-20 N213217-001 10927117 2037-08-15 Drug substance, Drug product 2021-04-20 N213217-001 11591340 2037-08-15 U-1745 2023-03-08 N213217-001 11591340 2037-08-15 U-2145 2023-03-08 N213217-001 11591340 2037-08-15 U-2537 2023-03-08 N213217-001 11591340 2037-08-15 U-2666 2023-03-08 N213217-001 11591340 2037-08-15 U-3063 2023-03-08 N213217-001 11591340 2037-08-15 U-3486 2023-03-08 N213217-001 11591340 2037-08-15 U-3727 2023-03-08 N213217-001 11591340 2037-08-15 U-3728 2023-03-08 N213217-001 11591340 2037-08-15 U-3729 2023-03-08 N213217-001 11851437 2037-08-15 Drug substance, Drug product 2024-01-23 N213217-001 11884674 2037-08-15 U-1745 2024-02-28 N213217-001 11884674 2037-08-15 U-2145 2024-02-28 N213217-001 11884674 2037-08-15 U-2537 2024-02-28 N213217-001 11884674 2037-08-15 U-2666 2024-02-28 N213217-001 11884674 2037-08-15 U-3063 2024-02-28 N213217-001 11884674 2037-08-15 U-3486 2024-02-28 N213217-001 11884674 2037-08-15 U-3860 2024-02-28 N213217-001 11970500 2037-08-15 U-1745 2024-05-09 N213217-001 11970500 2037-08-15 U-2145 2024-05-09 N213217-001 11970500 2037-08-15 U-2537 2024-05-09 N213217-001 11970500 2037-08-15 U-2666 2024-05-09 N213217-001 11970500 2037-08-15 U-3063 2024-05-09 N213217-001 11970500 2037-08-15 U-3486 2024-05-09 N213217-001 11970500 2037-08-15 U-3860 2024-05-09 N213217-001 11701357 2039-06-24 U-3860 2024-04-02 N213217-001 11786531 2043-01-19 U-3715 2023-11-02 N213217-001 11786531 2043-01-19 U-3716 2023-11-02 N213217-001 11786531 2043-01-19 U-3717 2023-11-02 N213217-001 11786531 2043-01-19 U-3718 2023-11-02 N213217-001 11786531 2043-01-19 U-3719 2023-11-02 N213217-001 11786531 2043-01-19 U-3720 2023-11-02 N213217-001 11786531 2043-01-19 U-3875 2023-11-02 N213217-001 11896596 2043-01-19 U-3715 2024-03-12 N213217-001 11896596 2043-01-19 U-3716 2024-03-12 N213217-001 11896596 2043-01-19 U-3717 2024-03-12 N213217-001 11896596 2043-01-19 U-3718 2024-03-12 N213217-001 11896596 2043-01-19 U-3719 2024-03-12 N213217-001 11896596 2043-01-19 U-3720 2024-03-12 N213217-001 11896596 2043-01-19 U-3875 2024-03-12 N213217-001 11911386 2043-01-19 U-3715 2024-02-28 N213217-001 11911386 2043-01-19 U-3716 2024-02-28 N213217-001 11911386 2043-01-19 U-3717 2024-02-28 N213217-001 11911386 2043-01-19 U-3718 2024-02-28 N213217-001 11911386 2043-01-19 U-3719 2024-02-28 N213217-001 11911386 2043-01-19 U-3720 2024-02-28 N213217-001 11911386 2043-01-19 U-3875 2024-02-28
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 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD 2019-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD 2019-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD 2019-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD 2019-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD, RS 2019-11-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213217-001 BRUKINSA 80MG CAPSULE / ORAL RLD 2019-11-14 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 38 · 1,492 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 N213217-001 10570139 2034-04-22 U-1745 2021-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 10570139 2034-04-22 U-2666 2021-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 10570139 2034-04-22 U-2537 2021-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 10570139 2034-04-22 U-3860 2021-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 10570139 2034-04-22 U-3063 2021-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 10570139 2034-04-22 U-3486 2021-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 10570139 2034-04-22 U-2145 2021-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11142528 2034-04-22 U-2666 Drug product 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11142528 2034-04-22 U-2537 Drug product 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11142528 2034-04-22 U-1745 Drug product 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11142528 2034-04-22 U-2145 Drug product 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11142528 2034-04-22 U-3063 Drug product 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11142528 2034-04-22 U-3860 Drug product 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11142528 2034-04-22 U-3486 Drug product 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 9447106 2034-04-22 U-2145 Drug substance, Drug product 2019-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 9447106 2034-04-22 U-1745 Drug substance, Drug product 2019-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 9447106 2034-04-22 U-3063 Drug substance, Drug product 2019-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 9447106 2034-04-22 U-2537 Drug substance, Drug product 2019-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 9447106 2034-04-22 U-2666 Drug substance, Drug product 2019-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 9447106 2034-04-22 U-3860 Drug substance, Drug product 2019-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 9447106 2034-04-22 U-3486 Drug substance, Drug product 2019-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 10927117 2037-08-15 Drug substance, Drug product 2021-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11591340 2037-08-15 U-1745 2023-03-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11591340 2037-08-15 U-2145 2023-03-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11591340 2037-08-15 U-2537 2023-03-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11591340 2037-08-15 U-2666 2023-03-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11591340 2037-08-15 U-3063 2023-03-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11591340 2037-08-15 U-3486 2023-03-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11591340 2037-08-15 U-3727 2023-03-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11591340 2037-08-15 U-3729 2023-03-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11591340 2037-08-15 U-3728 2023-03-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11851437 2037-08-15 Drug substance, Drug product 2024-01-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11884674 2037-08-15 U-1745 2024-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11884674 2037-08-15 U-2145 2024-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11884674 2037-08-15 U-2537 2024-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11884674 2037-08-15 U-2666 2024-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11884674 2037-08-15 U-3063 2024-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11884674 2037-08-15 U-3486 2024-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11884674 2037-08-15 U-3860 2024-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213217-001 11970500 2037-08-15 U-1745 2024-05-09 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 277 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72579-011 BRUKINSA zanubrutinib BEIGENE USA, INC. NDA Current 72579-011 BRUKINSA zanubrutinib BeiGene USA, Inc. NDA Current 72579-011 BRUKINSA zanubrutinib BEIGENE USA, INC. NDA Current 72579-011 BRUKINSA zanubrutinib BeiGene USA, Inc. NDA Current 72579-011 BRUKINSA zanubrutinib Beigene Usa, Inc. NDA Current 72579-011 BRUKINSA zanubrutinib Beigene Usa, Inc. NDA Current