Home Applications 211155 Application 211155
Type NDA
Sponsor VERASTEM INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COPIKTRA DUVELISIB CAPSULE;ORAL 15MG Yes No 002 COPIKTRA DUVELISIB CAPSULE;ORAL 25MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N211155-001 COPIKTRA DUVELISIB 15MG CAPSULE / ORAL RLD 2018-09-24 N211155-002 COPIKTRA DUVELISIB 25MG CAPSULE / ORAL RLD 2018-09-24
Orange Book patents# Current patent rows page 1 of 1 · 16 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211155-001 9216982 2029-01-05 U-2412 2018-10-23 N211155-001 9216982 2029-01-05 U-2413 2018-10-23 N211155-001 11312718 2032-01-10 Drug product 2022-06-03 N211155-001 9840505 2032-01-10 U-2412 2018-10-23 N211155-001 9840505 2032-01-10 U-2413 2018-10-23 N211155-001 RE46621 2032-05-17 Drug substance, Drug product 2018-10-23 N211155-001 8193182 2032-09-24 Drug substance 2018-10-23 N211155-001 12213983 2035-04-26 U-2412 2025-03-05 N211155-002 9216982 2029-01-05 U-2412 2018-10-23 N211155-002 9216982 2029-01-05 U-2413 2018-10-23 N211155-002 11312718 2032-01-10 Drug product 2022-06-03 N211155-002 9840505 2032-01-10 U-2412 2018-10-23 N211155-002 9840505 2032-01-10 U-2413 2018-10-23 N211155-002 RE46621 2032-05-17 Drug substance, Drug product 2018-10-23 N211155-002 8193182 2032-09-24 Drug substance 2018-10-23 N211155-002 12213983 2035-04-26 U-2412 2025-03-05
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 1 of 3 · 86 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 2026-09-14 22:38:34 2026-08 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD 2018-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD, RS 2018-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD, RS 2018-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211155-001 COPIKTRA 15MG CAPSULE / ORAL RLD 2018-09-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N211155-002 COPIKTRA 25MG CAPSULE / ORAL RLD, RS 2018-09-24 74a2ff9319b5…
Observed Orange Book patent history# Patent history page 1 of 15 · 592 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 N211155-001 9216982 2029-01-05 U-2413 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-001 9216982 2029-01-05 U-2412 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-001 11312718 2032-01-10 Drug product 2022-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-001 9840505 2032-01-10 U-2413 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-001 9840505 2032-01-10 U-2412 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-001 RE46621 2032-05-17 Drug substance, Drug product 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-001 8193182 2032-09-24 Drug substance 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-001 12213983 2035-04-26 U-2412 2025-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-002 9216982 2029-01-05 U-2413 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-002 9216982 2029-01-05 U-2412 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-002 11312718 2032-01-10 Drug product 2022-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-002 9840505 2032-01-10 U-2412 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-002 9840505 2032-01-10 U-2413 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-002 RE46621 2032-05-17 Drug substance, Drug product 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-002 8193182 2032-09-24 Drug substance 2018-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211155-002 12213983 2035-04-26 U-2412 2025-03-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211155-001 9216982 2029-01-05 U-2413 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-001 9216982 2029-01-05 U-2412 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-001 11312718 2032-01-10 Drug product 2022-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-001 9840505 2032-01-10 U-2413 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-001 9840505 2032-01-10 U-2412 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-001 RE46621 2032-05-17 Drug substance, Drug product 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-001 8193182 2032-09-24 Drug substance 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-001 12213983 2035-04-26 U-2412 2025-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-002 9216982 2029-01-05 U-2413 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-002 9216982 2029-01-05 U-2412 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-002 11312718 2032-01-10 Drug product 2022-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-002 9840505 2032-01-10 U-2412 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-002 9840505 2032-01-10 U-2413 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-002 RE46621 2032-05-17 Drug substance, Drug product 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-002 8193182 2032-09-24 Drug substance 2018-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211155-002 12213983 2035-04-26 U-2412 2025-03-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211155-001 9216982 2029-01-05 U-2413 2018-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211155-001 9216982 2029-01-05 U-2412 2018-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211155-001 8193182 2030-02-13 Drug substance 2018-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211155-001 11312718 2032-01-10 Drug product 2022-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211155-001 9840505 2032-01-10 U-2413 2018-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211155-001 9840505 2032-01-10 U-2412 2018-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211155-001 RE46621 2032-05-17 Drug substance, Drug product 2018-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211155-001 12213983 2035-04-26 U-2412 2025-03-05 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 154 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.
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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71779-115 Copiktra duvelisib Verastem, Inc. NDA Current 71779-115 Copiktra duvelisib Verastem, Inc. NDA Current 71779-115 Copiktra duvelisib Verastem, Inc. NDA Current 71779-125 Copiktra duvelisib Verastem, Inc. NDA Current 71779-125 Copiktra duvelisib Verastem, Inc. NDA Current 71779-125 Copiktra duvelisib Verastem, Inc. NDA Current 73116-115 COPIKTRA duvelisib Secura Bio, Inc. NDA Current 73116-125 COPIKTRA duvelisib Secura Bio, Inc. NDA Current 73116-215 COPIKTRA duvelisib Secura Bio, Inc. NDA Current 73116-225 COPIKTRA duvelisib Secura Bio, Inc. NDA Current