Home Applications 218037 Application 218037
Type NDA
Sponsor ALEXION PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VOYDEYA DANICOPAN TABLET;ORAL 50MG Yes No 002 VOYDEYA DANICOPAN TABLET;ORAL 100MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N218037-001 VOYDEYA DANICOPAN 50MG TABLET / ORAL RLD 2024-03-29 N218037-002 VOYDEYA DANICOPAN 100MG TABLET / ORAL RLD, RS 2024-03-29
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 N218037-002 12076319 2038-08-02 U-3933 2024-09-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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.
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 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 48 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 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 79d66fd596c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 60 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Voydeya DANICOPAN Alexion Pharmaceuticals Inc. ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 2026-05-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 218037 application number: NDA218037
Documents# Document, Submission type, Date table Document Submission type Date 82699 SUPPL 2025-06-30 78401 ORIG 2024-05-06 78027 ORIG 2024-04-01