Home Applications 218808 Application 218808
Type NDA
Sponsor NEUROCRINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CRENESSITY CRINECERFONT CAPSULE;ORAL 25MG Yes No 002 CRENESSITY CRINECERFONT CAPSULE;ORAL 50MG Yes No 003 CRENESSITY CRINECERFONT CAPSULE;ORAL 100MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218808-001 CRENESSITY CRINECERFONT 25MG CAPSULE / ORAL RLD 2024-12-13 N218808-002 CRENESSITY CRINECERFONT 50MG CAPSULE / ORAL RLD 2024-12-13 N218808-003 CRENESSITY CRINECERFONT 100MG CAPSULE / ORAL RLD, RS 2024-12-13
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218808-001 10905690 2035-01-21 U-4049 2025-01-10 N218808-001 11311544 2035-01-21 U-4049 2025-01-10 N218808-001 11730739 2035-01-21 U-4049 2025-01-10 N218808-001 12128033 2041-06-09 U-4049 Drug substance 2025-01-10 N218808-001 12582634 2043-01-12 Drug substance 2026-04-21 N218808-002 10905690 2035-01-21 U-4049 2025-01-10 N218808-002 11311544 2035-01-21 U-4049 2025-01-10 N218808-002 11730739 2035-01-21 U-4049 2025-01-10 N218808-002 12128033 2041-06-09 U-4049 Drug substance 2025-01-10 N218808-002 12582634 2043-01-12 Drug substance 2026-04-21 N218808-003 10905690 2035-01-21 U-4049 2025-01-10 N218808-003 11311544 2035-01-21 U-4049 2025-01-10 N218808-003 11730739 2035-01-21 U-4049 2025-01-10 N218808-003 12128033 2041-06-09 U-4049 Drug substance 2025-01-10 N218808-003 12582634 2043-01-12 Drug substance 2026-04-21
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.
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 N218808-001 CRENESSITY 25MG CAPSULE / ORAL RLD 2024-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-002 CRENESSITY 50MG CAPSULE / ORAL RLD 2024-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-003 CRENESSITY 100MG CAPSULE / ORAL RLD, RS 2024-12-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218808-001 CRENESSITY 25MG CAPSULE / ORAL RLD 2024-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-002 CRENESSITY 50MG CAPSULE / ORAL RLD 2024-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-003 CRENESSITY 100MG CAPSULE / ORAL RLD, RS 2024-12-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218808-001 CRENESSITY 25MG CAPSULE / ORAL RLD 2024-12-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218808-002 CRENESSITY 50MG CAPSULE / ORAL RLD 2024-12-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218808-003 CRENESSITY 100MG CAPSULE / ORAL RLD, RS 2024-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218808-001 CRENESSITY 25MG CAPSULE / ORAL RLD 2024-12-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218808-002 CRENESSITY 50MG CAPSULE / ORAL RLD 2024-12-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218808-003 CRENESSITY 100MG CAPSULE / ORAL RLD, RS 2024-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218808-001 CRENESSITY 25MG CAPSULE / ORAL RLD 2024-12-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218808-002 CRENESSITY 50MG CAPSULE / ORAL RLD 2024-12-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218808-003 CRENESSITY 100MG CAPSULE / ORAL RLD, RS 2024-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218808-001 CRENESSITY 25MG CAPSULE / ORAL RLD 2024-12-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218808-002 CRENESSITY 50MG CAPSULE / ORAL RLD 2024-12-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218808-003 CRENESSITY 100MG CAPSULE / ORAL RLD, RS 2024-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218808-001 CRENESSITY 25MG CAPSULE / ORAL RLD 2024-12-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218808-002 CRENESSITY 50MG CAPSULE / ORAL RLD 2024-12-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218808-003 CRENESSITY 100MG CAPSULE / ORAL RLD, RS 2024-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218808-001 CRENESSITY 25MG CAPSULE / ORAL RLD 2024-12-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218808-002 CRENESSITY 50MG CAPSULE / ORAL RLD 2024-12-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218808-003 CRENESSITY 100MG CAPSULE / ORAL RLD, RS 2024-12-13 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218808-001 CRENESSITY 25MG CAPSULE / ORAL RLD 2024-12-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218808-002 CRENESSITY 50MG CAPSULE / ORAL RLD 2024-12-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218808-003 CRENESSITY 100MG CAPSULE / ORAL RLD, RS 2024-12-13 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 105 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 N218808-001 10905690 2035-01-21 U-4049 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-001 11311544 2035-01-21 U-4049 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-001 11730739 2035-01-21 U-4049 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-001 12128033 2041-06-09 U-4049 Drug substance 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-001 12582634 2043-01-12 Drug substance 2026-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-002 10905690 2035-01-21 U-4049 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-002 11311544 2035-01-21 U-4049 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-002 11730739 2035-01-21 U-4049 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-002 12128033 2041-06-09 U-4049 Drug substance 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-002 12582634 2043-01-12 Drug substance 2026-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-003 10905690 2035-01-21 U-4049 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-003 11311544 2035-01-21 U-4049 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-003 11730739 2035-01-21 U-4049 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-003 12128033 2041-06-09 U-4049 Drug substance 2025-01-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218808-003 12582634 2043-01-12 Drug substance 2026-04-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218808-001 10905690 2035-01-21 U-4049 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-001 11311544 2035-01-21 U-4049 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-001 11730739 2035-01-21 U-4049 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-001 12128033 2041-06-09 U-4049 Drug substance 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-001 12582634 2043-01-12 Drug substance 2026-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-002 10905690 2035-01-21 U-4049 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-002 11311544 2035-01-21 U-4049 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-002 11730739 2035-01-21 U-4049 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-002 12128033 2041-06-09 U-4049 Drug substance 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-002 12582634 2043-01-12 Drug substance 2026-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-003 10905690 2035-01-21 U-4049 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-003 11311544 2035-01-21 U-4049 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-003 11730739 2035-01-21 U-4049 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-003 12128033 2041-06-09 U-4049 Drug substance 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218808-003 12582634 2043-01-12 Drug substance 2026-04-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218808-001 10905690 2035-01-21 U-4049 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218808-001 11311544 2035-01-21 U-4049 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218808-001 11730739 2035-01-21 U-4049 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218808-001 12128033 2041-06-09 U-4049 Drug substance 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218808-002 10905690 2035-01-21 U-4049 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218808-002 11311544 2035-01-21 U-4049 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218808-002 11730739 2035-01-21 U-4049 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218808-002 12128033 2041-06-09 U-4049 Drug substance 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218808-003 10905690 2035-01-21 U-4049 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218808-003 11311544 2035-01-21 U-4049 2025-01-10 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 51 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 80832 ORIG 2025-01-10 80597 ORIG 2024-12-16 80574 ORIG 2024-12-13