Home Applications 213411 Application 213411
Type NDA
Sponsor SEATTLE GENETICS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TUKYSA TUCATINIB TABLET;ORAL 50MG Yes No 002 TUKYSA TUCATINIB TABLET;ORAL 150MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213411-001 TUKYSA TUCATINIB 50MG TABLET / ORAL RLD 2020-04-17 N213411-002 TUKYSA TUCATINIB 150MG TABLET / ORAL RLD, RS 2020-04-17
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213411-001 9693989 2027-05-09 U-2788 Drug product 2020-04-29 N213411-001 9457093 2032-10-12 U-2788 Drug product 2020-04-29 N213411-001 11504370 2033-03-25 U-2788 2022-12-05 N213411-001 8648087 2034-04-17 Drug substance, Drug product 2020-04-29 N213411-001 11207324 2038-04-27 U-3783 2023-02-02 N213411-001 11666572 2038-04-27 U-3783 2024-01-29 N213411-001 12048698 2038-04-27 U-3783 2024-08-28 N213411-002 9693989 2027-05-09 U-2788 Drug product 2020-04-29 N213411-002 9457093 2032-10-12 U-2788 Drug product 2020-04-29 N213411-002 11504370 2033-03-25 U-2788 2022-12-05 N213411-002 8648087 2034-04-17 Drug substance, Drug product 2020-04-29 N213411-002 11207324 2038-04-27 U-3783 2023-02-02 N213411-002 11666572 2038-04-27 U-3783 2024-01-29 N213411-002 12048698 2038-04-27 U-3783 2024-08-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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.
Product history page 2 of 2 · 80 observed 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 2022-03-09 01:35 UTC 2022-03 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 e64feba35796…2022-09-29 23:25 UTC 2022-09 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 13 · 484 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N213411-001 9693989 2027-05-09 U-2788 Drug product 2020-04-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-001 9457093 2032-10-12 U-2788 Drug product 2020-04-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-001 11504370 2033-03-25 U-2788 2022-12-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-001 8648087 2034-04-17 Drug substance, Drug product 2020-04-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-001 11207324 2038-04-27 U-3783 2023-02-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-001 11666572 2038-04-27 U-3783 2024-01-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-001 12048698 2038-04-27 U-3783 2024-08-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-002 9693989 2027-05-09 U-2788 Drug product 2020-04-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-002 9457093 2032-10-12 U-2788 Drug product 2020-04-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-002 11504370 2033-03-25 U-2788 2022-12-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-002 8648087 2034-04-17 Drug substance, Drug product 2020-04-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-002 11207324 2038-04-27 U-3783 2023-02-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-002 11666572 2038-04-27 U-3783 2024-01-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-002 12048698 2038-04-27 U-3783 2024-08-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N213411-001 9693989 2027-05-09 U-2788 Drug product 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-001 9457093 2032-10-12 U-2788 Drug product 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-001 11504370 2033-03-25 U-2788 2022-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-001 8648087 2034-04-17 Drug substance, Drug product 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-001 11207324 2038-04-27 U-3783 2023-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-001 11666572 2038-04-27 U-3783 2024-01-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-001 12048698 2038-04-27 U-3783 2024-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-002 9693989 2027-05-09 U-2788 Drug product 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-002 9457093 2032-10-12 U-2788 Drug product 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-002 11504370 2033-03-25 U-2788 2022-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-002 8648087 2034-04-17 Drug substance, Drug product 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-002 11207324 2038-04-27 U-3783 2023-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-002 11666572 2038-04-27 U-3783 2024-01-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-002 12048698 2038-04-27 U-3783 2024-08-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213411-001 9693989 2027-05-09 U-2788 Drug product 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-001 9457093 2032-10-12 U-2788 Drug product 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-001 11504370 2033-03-25 U-2788 2022-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-001 8648087 2034-04-17 Drug substance, Drug product 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-001 11207324 2038-04-27 U-3783 2023-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-001 11666572 2038-04-27 U-3783 2024-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-001 12048698 2038-04-27 U-3783 2024-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-002 9693989 2027-05-09 U-2788 Drug product 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-002 9457093 2032-10-12 U-2788 Drug product 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-002 11504370 2033-03-25 U-2788 2022-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-002 8648087 2034-04-17 Drug substance, Drug product 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-002 11207324 2038-04-27 U-3783 2023-02-02 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 254 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 51144-001 TUKYSA tucatinib SEAGEN INC. NDA Current 51144-001 TUKYSA tucatinib SEAGEN INC. NDA Current 51144-001 TUKYSA tucatinib Seattle Genetics, Inc. NDA Current 51144-002 TUKYSA tucatinib SEAGEN INC. NDA Current 51144-002 TUKYSA tucatinib SEAGEN INC. NDA Current 51144-002 TUKYSA tucatinib Seattle Genetics, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 73259 SUPPL 2023-01-20 73255 SUPPL 2023-01-20 63055 ORIG 2020-05-18 62594 ORIG 2020-04-20 62591 ORIG 2020-04-17