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 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 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 2026-08-18 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 36 · 1,424 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 N213217-001 10570139 2034-04-22 U-1745 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 10570139 2034-04-22 U-2666 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 10570139 2034-04-22 U-2537 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 10570139 2034-04-22 U-3860 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 10570139 2034-04-22 U-3063 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 10570139 2034-04-22 U-3486 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 10570139 2034-04-22 U-2145 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11142528 2034-04-22 U-2666 Drug product 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11142528 2034-04-22 U-2537 Drug product 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11142528 2034-04-22 U-1745 Drug product 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11142528 2034-04-22 U-2145 Drug product 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11142528 2034-04-22 U-3063 Drug product 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11142528 2034-04-22 U-3860 Drug product 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11142528 2034-04-22 U-3486 Drug product 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 9447106 2034-04-22 U-2145 Drug substance, Drug product 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 9447106 2034-04-22 U-1745 Drug substance, Drug product 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 9447106 2034-04-22 U-3063 Drug substance, Drug product 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 9447106 2034-04-22 U-2537 Drug substance, Drug product 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 9447106 2034-04-22 U-2666 Drug substance, Drug product 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 9447106 2034-04-22 U-3860 Drug substance, Drug product 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 9447106 2034-04-22 U-3486 Drug substance, Drug product 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 10927117 2037-08-15 Drug substance, Drug product 2021-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11591340 2037-08-15 U-1745 2023-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11591340 2037-08-15 U-2145 2023-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11591340 2037-08-15 U-2537 2023-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11591340 2037-08-15 U-2666 2023-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11591340 2037-08-15 U-3063 2023-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11591340 2037-08-15 U-3486 2023-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11591340 2037-08-15 U-3727 2023-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11591340 2037-08-15 U-3729 2023-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11591340 2037-08-15 U-3728 2023-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11851437 2037-08-15 Drug substance, Drug product 2024-01-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11884674 2037-08-15 U-1745 2024-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11884674 2037-08-15 U-2145 2024-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11884674 2037-08-15 U-2537 2024-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11884674 2037-08-15 U-2666 2024-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11884674 2037-08-15 U-3063 2024-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11884674 2037-08-15 U-3486 2024-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11884674 2037-08-15 U-3860 2024-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213217-001 11970500 2037-08-15 U-1745 2024-05-09 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 270 observed states.
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.
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