Home Applications 219776 Application 219776
Type NDA
Sponsor BIOCRYST Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE PELLETS;ORAL EQ 72MG BASE/PACKET Yes No 002 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE PELLETS;ORAL EQ 96MG BASE/PACKET Yes No 003 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE PELLETS;ORAL EQ 108MG BASE/PACKET Yes No 004 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE PELLETS;ORAL EQ 132MG BASE/PACKET Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219776-001 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 N219776-002 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 N219776-003 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 N219776-004 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11
Orange Book patents# Current patent rows page 1 of 2 · 128 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219776-001 10329260 2035-03-09 Drug substance 2026-06-10 N219776-001 10689346 2035-03-09 U-4535 2026-06-10 N219776-001 11230530 2035-03-09 U-4535 2026-06-10 N219776-001 11708333 2035-03-09 U-4535 2026-06-10 N219776-001 12116346 2035-03-09 Drug substance 2026-06-10 N219776-001 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 N219776-001 10329260*PED 2035-09-09 Pediatric extension N219776-001 10689346*PED 2035-09-09 Pediatric extension N219776-001 11230530*PED 2035-09-09 Pediatric extension N219776-001 11708333*PED 2035-09-09 Pediatric extension N219776-001 12116346*PED 2035-09-09 Pediatric extension N219776-001 10125102*PED 2035-10-07 Pediatric extension N219776-001 10662160 2039-11-01 U-4535 Drug substance 2026-06-10 N219776-001 11117867 2039-11-01 U-4535 Drug product 2026-06-10 N219776-001 11618733 2039-11-01 U-4535 2026-06-10 N219776-001 12344585 2039-11-01 U-4535 2026-06-10 N219776-001 12545645 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-001 12545646 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-001 12545647 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-001 12552750 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-001 12590068 2039-11-01 Drug substance, Drug product 2026-04-03 N219776-001 12590069 2039-11-01 Drug substance, Drug product 2026-04-03 N219776-001 10662160*PED 2040-05-01 Pediatric extension N219776-001 11117867*PED 2040-05-01 Pediatric extension N219776-001 11618733*PED 2040-05-01 Pediatric extension N219776-001 12344585*PED 2040-05-01 Pediatric extension N219776-001 12545645*PED 2040-05-01 Pediatric extension N219776-001 12545646*PED 2040-05-01 Pediatric extension N219776-001 12545647*PED 2040-05-01 Pediatric extension N219776-001 12552750*PED 2040-05-01 Pediatric extension N219776-001 12590068*PED 2040-05-01 Pediatric extension N219776-001 12590069*PED 2040-05-01 Pediatric extension N219776-002 10329260 2035-03-09 Drug substance 2026-06-10 N219776-002 10689346 2035-03-09 U-4535 2026-06-10 N219776-002 11230530 2035-03-09 U-4535 2026-06-10 N219776-002 11708333 2035-03-09 U-4535 2026-06-10 N219776-002 12116346 2035-03-09 Drug substance 2026-06-10 N219776-002 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 N219776-002 10329260*PED 2035-09-09 Pediatric extension N219776-002 10689346*PED 2035-09-09 Pediatric extension N219776-002 11230530*PED 2035-09-09 Pediatric extension N219776-002 11708333*PED 2035-09-09 Pediatric extension N219776-002 12116346*PED 2035-09-09 Pediatric extension N219776-002 10125102*PED 2035-10-07 Pediatric extension N219776-002 10662160 2039-11-01 U-4535 Drug substance 2026-06-10 N219776-002 11117867 2039-11-01 U-4535 Drug product 2026-06-10 N219776-002 11618733 2039-11-01 U-4535 2026-06-10 N219776-002 12344585 2039-11-01 U-4535 2026-06-10 N219776-002 12545645 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-002 12545646 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-002 12545647 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-002 12552750 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-002 12590068 2039-11-01 Drug substance, Drug product 2026-04-03 N219776-002 12590069 2039-11-01 Drug substance, Drug product 2026-04-03 N219776-002 10662160*PED 2040-05-01 Pediatric extension N219776-002 11117867*PED 2040-05-01 Pediatric extension N219776-002 11618733*PED 2040-05-01 Pediatric extension N219776-002 12344585*PED 2040-05-01 Pediatric extension N219776-002 12545645*PED 2040-05-01 Pediatric extension N219776-002 12545646*PED 2040-05-01 Pediatric extension N219776-002 12545647*PED 2040-05-01 Pediatric extension N219776-002 12552750*PED 2040-05-01 Pediatric extension N219776-002 12590068*PED 2040-05-01 Pediatric extension N219776-002 12590069*PED 2040-05-01 Pediatric extension N219776-003 10329260 2035-03-09 Drug substance 2026-06-10 N219776-003 10689346 2035-03-09 U-4535 2026-06-10 N219776-003 11230530 2035-03-09 U-4535 2026-06-10 N219776-003 11708333 2035-03-09 U-4535 2026-06-10 N219776-003 12116346 2035-03-09 Drug substance 2026-06-10 N219776-003 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 N219776-003 10329260*PED 2035-09-09 Pediatric extension N219776-003 10689346*PED 2035-09-09 Pediatric extension N219776-003 11230530*PED 2035-09-09 Pediatric extension N219776-003 11708333*PED 2035-09-09 Pediatric extension N219776-003 12116346*PED 2035-09-09 Pediatric extension N219776-003 10125102*PED 2035-10-07 Pediatric extension N219776-003 10662160 2039-11-01 U-4535 Drug substance 2026-06-10 N219776-003 11117867 2039-11-01 U-4535 Drug product 2026-06-10 N219776-003 11618733 2039-11-01 U-4535 2026-06-10 N219776-003 12344585 2039-11-01 U-4535 2026-06-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 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 2026-10-15 13:18:30 2026-09 N219776-001 ORLADEYO EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 ORLADEYO EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-003 ORLADEYO EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-004 ORLADEYO EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 N219776-001 ORLADEYO EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219776-002 ORLADEYO EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219776-003 ORLADEYO EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219776-004 ORLADEYO EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219776-001 ORLADEYO EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219776-002 ORLADEYO EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219776-003 ORLADEYO EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219776-004 ORLADEYO EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219776-001 ORLADEYO EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219776-002 ORLADEYO EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219776-003 ORLADEYO EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219776-004 ORLADEYO EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 ORLADEYO EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 ORLADEYO EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-003 ORLADEYO EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-004 ORLADEYO EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 13 · 512 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 N219776-001 10329260 2035-03-09 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10689346 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11230530 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11708333 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12116346 2035-03-09 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10329260*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10689346*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11230530*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11708333*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12116346*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10125102*PED 2035-10-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10662160 2039-11-01 U-4535 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11117867 2039-11-01 U-4535 Drug product 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11618733 2039-11-01 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12344585 2039-11-01 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545645 2039-11-01 Drug substance, Drug product 2026-03-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545646 2039-11-01 Drug substance, Drug product 2026-03-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545647 2039-11-01 Drug substance, Drug product 2026-03-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12552750 2039-11-01 Drug substance, Drug product 2026-03-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12590068 2039-11-01 Drug substance, Drug product 2026-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12590069 2039-11-01 Drug substance, Drug product 2026-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10662160*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11117867*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11618733*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12344585*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545645*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545646*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545647*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12552750*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12590068*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12590069*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 10329260 2035-03-09 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 10689346 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 11230530 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 11708333 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 12116346 2035-03-09 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 10329260*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 10689346*PED 2035-09-09 Pediatric extension c2088c7a36db…
Observed Orange Book exclusivity history# 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 85170 ORIG 2026-02-26 85108 ORIG 2026-02-23 84402 ORIG 2025-12-15