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 44 .
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 · 76 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 2026-10-15 13:18:30 2026-09 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214094-001 ORLADEYO EQ 110MG BASE CAPSULE / ORAL RLD 2020-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214094-002 ORLADEYO EQ 150MG BASE CAPSULE / ORAL RLD, RS 2020-12-03 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 20 · 792 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N214094-001 10329260 2035-03-09 Drug substance 2020-12-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 10689346 2035-03-09 U-3010 2020-12-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 11230530 2035-03-09 U-3300 2022-02-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 11708333 2035-03-09 U-3300 2023-08-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12116346 2035-03-09 Drug substance 2024-11-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 10125102 2035-04-07 U-3010 Drug substance 2020-12-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 10329260*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 10689346*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 11230530*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 11708333*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12116346*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 10125102*PED 2035-10-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 10662160 2039-11-01 U-3010 Drug substance 2020-12-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 11117867 2039-11-01 U-3010 Drug product 2021-10-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 11618733 2039-11-01 U-3300 2023-05-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12344585 2039-11-01 U-3010 2025-07-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12545645 2039-11-01 Drug substance, Drug product 2026-03-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12545646 2039-11-01 Drug substance, Drug product 2026-03-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12545647 2039-11-01 Drug substance, Drug product 2026-03-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12552750 2039-11-01 Drug substance, Drug product 2026-03-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12590068 2039-11-01 Drug substance, Drug product 2026-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12590069 2039-11-01 Drug substance, Drug product 2026-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 10662160*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 11117867*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 11618733*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12344585*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12545645*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12545646*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12545647*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12552750*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12590068*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-001 12590069*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-002 10329260 2035-03-09 Drug substance 2020-12-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-002 10689346 2035-03-09 U-3010 2020-12-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-002 11230530 2035-03-09 U-3300 2022-02-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-002 11708333 2035-03-09 U-3300 2023-08-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-002 12116346 2035-03-09 Drug substance 2024-11-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-002 10125102 2035-04-07 U-3010 Drug substance 2020-12-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-002 10329260*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N214094-002 10689346*PED 2035-09-09 Pediatric extension c2088c7a36db…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 152 observed states.
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 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