Home NDC 73116-125-02 COPIKTRA
Product NDC 73116-125
Requested package NDC 73116-125-02
11-digit product format 731160125
Labeler code 73116
Product ID 73116-125_b2586d9d-9395-46d3-a0ff-d64c0ecb8e21
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name duvelisib
Dosage form CAPSULE
Route ORAL
Labeler Secura Bio, Inc.
Application NDA211155
Marketing category NDA
Marketing start 2018-09-25
Marketing end 0000-00-00
Substance DUVELISIB
Active strength 25 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COPIKTRA DUVELISIB Secura Bio, Inc e3c5ac56-e1f6-473a-bc73-687836534780 2025-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 211155 application number: NDA211155
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 73116-125-02 73116012502 1 PACKAGE in 1 CARTON (73116-125-02) > 28 BLISTER PACK in 1 PACKAGE (73116-125-04) > 1 CAPSULE in 1 BLISTER PACK 1 package 2018-09-25 0000-00-00 No No Current