Home Applications 214094 Application 214094
Type NDA
Sponsor BIOCRYST PHARMACEUTICALS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORLADEYO BEROTRALSTAT CAPSULE; ORAL 150MG Yes No 002 ORLADEYO BEROTRALSTAT CAPSULE; ORAL 110MG Yes No
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 N214094-001 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 N214094-002 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03
Orange Book patents# Current patent rows page 1 of 1 · 64 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214094-001 10329260 2035-03-09 Drug substance 2020-12-23 N214094-001 10689346 2035-03-09 U-3010 2020-12-23 N214094-001 11230530 2035-03-09 U-3300 2022-02-17 N214094-001 11708333 2035-03-09 U-3300 2023-08-24 N214094-001 12116346 2035-03-09 Drug substance 2024-11-12 N214094-001 10125102 2035-04-07 U-3010 Drug substance 2020-12-23 N214094-001 10329260*PED 2035-09-09 Pediatric extension N214094-001 10689346*PED 2035-09-09 Pediatric extension N214094-001 11230530*PED 2035-09-09 Pediatric extension N214094-001 11708333*PED 2035-09-09 Pediatric extension N214094-001 12116346*PED 2035-09-09 Pediatric extension N214094-001 10125102*PED 2035-10-07 Pediatric extension N214094-001 10662160 2039-11-01 U-3010 Drug substance 2020-12-23 N214094-001 11117867 2039-11-01 U-3010 Drug product 2021-10-13 N214094-001 11618733 2039-11-01 U-3300 2023-05-04 N214094-001 12344585 2039-11-01 U-3010 2025-07-28 N214094-001 12545645 2039-11-01 Drug substance, Drug product 2026-03-02 N214094-001 12545646 2039-11-01 Drug substance, Drug product 2026-03-02 N214094-001 12545647 2039-11-01 Drug substance, Drug product 2026-03-02 N214094-001 12552750 2039-11-01 Drug substance, Drug product 2026-03-02 N214094-001 12590068 2039-11-01 Drug substance, Drug product 2026-04-03 N214094-001 12590069 2039-11-01 Drug substance, Drug product 2026-04-03 N214094-001 10662160*PED 2040-05-01 Pediatric extension N214094-001 11117867*PED 2040-05-01 Pediatric extension N214094-001 11618733*PED 2040-05-01 Pediatric extension N214094-001 12344585*PED 2040-05-01 Pediatric extension N214094-001 12545645*PED 2040-05-01 Pediatric extension N214094-001 12545646*PED 2040-05-01 Pediatric extension N214094-001 12545647*PED 2040-05-01 Pediatric extension N214094-001 12552750*PED 2040-05-01 Pediatric extension N214094-001 12590068*PED 2040-05-01 Pediatric extension N214094-001 12590069*PED 2040-05-01 Pediatric extension N214094-002 10329260 2035-03-09 Drug substance 2020-12-23 N214094-002 10689346 2035-03-09 U-3010 2020-12-23 N214094-002 11230530 2035-03-09 U-3300 2022-02-17 N214094-002 11708333 2035-03-09 U-3300 2023-08-24 N214094-002 12116346 2035-03-09 Drug substance 2024-11-12 N214094-002 10125102 2035-04-07 U-3010 Drug substance 2020-12-23 N214094-002 10329260*PED 2035-09-09 Pediatric extension N214094-002 10689346*PED 2035-09-09 Pediatric extension N214094-002 11230530*PED 2035-09-09 Pediatric extension N214094-002 11708333*PED 2035-09-09 Pediatric extension N214094-002 12116346*PED 2035-09-09 Pediatric extension N214094-002 10125102*PED 2035-10-07 Pediatric extension N214094-002 10662160 2039-11-01 U-3010 Drug substance 2020-12-23 N214094-002 11117867 2039-11-01 U-3010 Drug product 2021-10-13 N214094-002 11618733 2039-11-01 U-3300 2023-05-04 N214094-002 12344585 2039-11-01 U-3010 2025-07-28 N214094-002 12545645 2039-11-01 Drug substance, Drug product 2026-03-02 N214094-002 12545646 2039-11-01 Drug substance, Drug product 2026-03-02 N214094-002 12545647 2039-11-01 Drug substance, Drug product 2026-03-02 N214094-002 12552750 2039-11-01 Drug substance, Drug product 2026-03-02 N214094-002 12590068 2039-11-01 Drug substance, Drug product 2026-04-03 N214094-002 12590069 2039-11-01 Drug substance, Drug product 2026-04-03 N214094-002 10662160*PED 2040-05-01 Pediatric extension N214094-002 11117867*PED 2040-05-01 Pediatric extension N214094-002 11618733*PED 2040-05-01 Pediatric extension N214094-002 12344585*PED 2040-05-01 Pediatric extension N214094-002 12545645*PED 2040-05-01 Pediatric extension N214094-002 12545646*PED 2040-05-01 Pediatric extension N214094-002 12545647*PED 2040-05-01 Pediatric extension N214094-002 12552750*PED 2040-05-01 Pediatric extension N214094-002 12590068*PED 2040-05-01 Pediatric extension N214094-002 12590069*PED 2040-05-01 Pediatric extension
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.
Product history page 1 of 2 · 70 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 2026-02-19 14:30 UTC 2026-02 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 87673890dc5c…
Observed Orange Book patent history# Patent history page 1 of 15 · 600 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 N214094-001 10329260 2035-03-09 Drug substance 2020-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 10689346 2035-03-09 U-3010 2020-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 11230530 2035-03-09 U-3300 2022-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 11708333 2035-03-09 U-3300 2023-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 12116346 2035-03-09 Drug substance 2024-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 10125102 2035-04-07 U-3010 Drug substance 2020-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 10329260*PED 2035-09-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 10689346*PED 2035-09-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 11230530*PED 2035-09-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 11708333*PED 2035-09-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 12116346*PED 2035-09-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 10125102*PED 2035-10-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 10662160 2039-11-01 U-3010 Drug substance 2020-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 11117867 2039-11-01 U-3010 Drug product 2021-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 11618733 2039-11-01 U-3300 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 12344585 2039-11-01 U-3010 2025-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 10662160*PED 2040-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 11117867*PED 2040-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 11618733*PED 2040-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-001 12344585*PED 2040-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 10329260 2035-03-09 Drug substance 2020-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 10689346 2035-03-09 U-3010 2020-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 11230530 2035-03-09 U-3300 2022-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 11708333 2035-03-09 U-3300 2023-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 12116346 2035-03-09 Drug substance 2024-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 10125102 2035-04-07 U-3010 Drug substance 2020-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 10329260*PED 2035-09-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 10689346*PED 2035-09-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 11230530*PED 2035-09-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 11708333*PED 2035-09-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 12116346*PED 2035-09-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 10125102*PED 2035-10-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 10662160 2039-11-01 U-3010 Drug substance 2020-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 11117867 2039-11-01 U-3010 Drug product 2021-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 11618733 2039-11-01 U-3300 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 12344585 2039-11-01 U-3010 2025-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 10662160*PED 2040-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 11117867*PED 2040-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 11618733*PED 2040-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214094-002 12344585*PED 2040-05-01 Pediatric extension 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 140 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.
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 72769-101 Orladeyo Berotralstat hydrochloride BioCryst Pharmaceuticals Inc. NDA Current 72769-101 Orladeyo Berotralstat hydrochloride BioCryst Pharmaceuticals Inc. NDA Current 72769-102 Orladeyo Berotralstat hydrochloride BioCryst Pharmaceuticals Inc. NDA Current 72769-102 Orladeyo Berotralstat hydrochloride BioCryst Pharmaceuticals Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84666 SUPPL 2026-01-06 84621 SUPPL 2025-12-31 79961 SUPPL 2024-10-22 79956 SUPPL 2024-10-22 76659 SUPPL 2023-11-24 76649 SUPPL 2023-11-22 65782 ORIG 2020-12-30 65570 ORIG 2020-12-10 65513 ORIG 2020-12-07