Home Applications 214985 Application 214985
Type NDA
Sponsor IDORSIA PHARMACEUTICALS LTD. Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QUVIVIQ DARIDOREXANT TABLET; ORAL 25MG No No 002 QUVIVIQ DARIDOREXANT TABLET; ORAL 50MG No No
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 N214985-001 QUVIVIQ DARIDOREXANT HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 N214985-002 QUVIVIQ DARIDOREXANT HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214985-001 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 N214985-001 10023560 2034-12-02 U-620 2022-05-03 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 N214985-002 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 N214985-002 10023560 2034-12-02 U-620 2022-05-03 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03
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 1 of 2 · 62 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 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 ea1830bbd6c7…
Observed Orange Book patent history# Patent history page 1 of 5 · 186 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 N214985-001 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-001 10023560 2034-12-02 U-620 2022-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-002 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-002 10023560 2034-12-02 U-620 2022-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214985-001 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-001 10023560 2034-12-02 U-620 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-002 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-002 10023560 2034-12-02 U-620 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214985-001 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-001 10023560 2034-12-02 U-620 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-002 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-002 10023560 2034-12-02 U-620 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-001 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-001 10023560 2034-12-02 U-620 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-002 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-002 10023560 2034-12-02 U-620 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214985-001 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-001 10023560 2034-12-02 U-620 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-002 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-002 10023560 2034-12-02 U-620 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-001 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-001 10023560 2034-12-02 U-620 2022-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-002 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-002 10023560 2034-12-02 U-620 2022-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-001 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-001 10023560 2034-12-02 U-620 2022-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-002 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 2 of 3 · 100 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 80491-7825 QUVIVIQ Daridorexant Idorsia Pharmaceuticals Ltd NDA Current 80491-7825 QUVIVIQ Daridorexant Idorsia Pharmaceuticals Ltd NDA Current 80491-7850 QUVIVIQ Daridorexant Idorsia Pharmaceuticals Ltd NDA Current 80491-7850 QUVIVIQ Daridorexant Idorsia Pharmaceuticals Ltd NDA Current