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 1 .
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 2026-02-19 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 4 · 128 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10329260 2035-03-09 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10689346 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11230530 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11708333 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12116346 2035-03-09 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10329260*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10689346*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11230530*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11708333*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12116346*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10125102*PED 2035-10-07 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10662160 2039-11-01 U-4535 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11117867 2039-11-01 U-4535 Drug product 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11618733 2039-11-01 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12344585 2039-11-01 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545645 2039-11-01 Drug substance, Drug product 2026-03-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545646 2039-11-01 Drug substance, Drug product 2026-03-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545647 2039-11-01 Drug substance, Drug product 2026-03-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12552750 2039-11-01 Drug substance, Drug product 2026-03-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12590068 2039-11-01 Drug substance, Drug product 2026-04-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12590069 2039-11-01 Drug substance, Drug product 2026-04-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10662160*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11117867*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11618733*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12344585*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545645*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545646*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545647*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12552750*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12590068*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12590069*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 10329260 2035-03-09 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 10689346 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 11230530 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 11708333 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 12116346 2035-03-09 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 10329260*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 10689346*PED 2035-09-09 Pediatric extension a50c72e98297…
Observed Orange Book exclusivity history# 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 Orladeyo BEROTRALSTAT HYDROCHLORIDE BioCryst Pharmaceuticals, Inc. 3527ece1-e7e0-40b1-b0c5-6baeb0deabeb 2026-02-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 219776 application number: NDA219776
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