Home Applications 216718 Application 216718
Type NDA
Sponsor BIOGEN US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SKYCLARYS OMAVELOXOLONE CAPSULE;ORAL 50MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N216718-001 SKYCLARYS OMAVELOXOLONE 50MG CAPSULE / ORAL RLD, RS 2023-02-28
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216718-001 11091430 2029-04-20 U-3552 2023-03-29 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216718-001 M-270 2027-12-20 N216718-001 NCE 2028-02-28 N216718-001 ODE-427 2030-02-28
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 2026-02-19 14:30 UTC 2026-02 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N216718-001 11091430 2029-04-20 U-3552 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 11091430 2029-04-20 U-3552 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216718-001 11091430 2029-04-20 U-3552 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 11091430 2029-04-20 U-3552 2023-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 11091430 2029-04-20 U-3552 2023-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 50 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.
Documents# Document, Submission type, Date table Document Submission type Date 85668 SUPPL 2026-04-10 85657 SUPPL 2026-04-09 80720 SUPPL 2024-12-26 80719 SUPPL 2024-12-26 80696 SUPPL 2024-12-23 80695 SUPPL 2024-12-23 77319 SUPPL 2024-01-26 77315 SUPPL 2024-01-26 77314 SUPPL 2024-01-26 73907 ORIG 2023-03-30 73643 ORIG 2023-03-01 73632 ORIG 2023-02-28