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Orladeyo
Berotralstat hydrochloride · Pellet
Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from
public FDA and NLM data. Always confirm against the manufacturer's current
prescribing information. Report adverse events to FDA MedWatch.
Overview
Brand name
Orladeyo
Generic name
Berotralstat hydrochloride
Dosage form
Pellet
Route
Oral
Marketing category
NDA · NDA
Labeler
BioCryst Pharmaceuticals, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
4
Packages
4
Data completeness
54%
of corroborating sources present
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryDosage form
Pellet
Route of administration
Oral
Presentations
8
Pharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Cytochrome P450 2D6 Inhibitors [MoA] | MoA | All 72 members |
| Cytochrome P450 3A4 Inhibitors [MoA] | MoA | All 118 members |
| Kallikrein Inhibitors [MoA] | MoA | 3 members — no class page |
| P-Glycoprotein Inhibitors [MoA] | MoA | All 105 members |
| Plasma Kallikrein Inhibitor [EPC] | EPC | 3 members — no class page |
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
219776
Application type
NDA · New Drug Application
Approval date
December 11, 2025
Sponsor
BIOCRYST
Products on application
4
Submissions recorded
1
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 219776-001 | ORLADEYO | PELLETS | BEROTRALSTAT DIHYDROCHLORIDE | Prescription | — | RLD | |
| 219776-002 | ORLADEYO | PELLETS | BEROTRALSTAT DIHYDROCHLORIDE | Prescription | — | RLD | |
| 219776-003 | ORLADEYO | PELLETS | BEROTRALSTAT DIHYDROCHLORIDE | Prescription | — | RLD | |
| 219776-004 | ORLADEYO | PELLETS | BEROTRALSTAT DIHYDROCHLORIDE | Prescription | — | RLD RS |
Therapeutic equivalence
Source: Orange BookTE code
—
Reference Listed Drug
Yes
Reference Standard
Yes
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Patents and exclusivity
Source: Orange Book| Patent | Expires | Product | Substance | Use code | Submitted |
|---|---|---|---|---|---|
| 11708333 | March 9, 2035 | 001 | No | U-4535 | June 10, 2026 |
| 11230530 | March 9, 2035 | 001 | No | U-4535 | June 10, 2026 |
| 10689346 | March 9, 2035 | 001 | No | U-4535 | June 10, 2026 |
| 12116346 | March 9, 2035 | 001 | Yes | June 10, 2026 | |
| 10329260 | March 9, 2035 | 001 | Yes | June 10, 2026 | |
| 11708333 | March 9, 2035 | 002 | No | U-4535 | June 10, 2026 |
| 11230530 | March 9, 2035 | 002 | No | U-4535 | June 10, 2026 |
| 10689346 | March 9, 2035 | 002 | No | U-4535 | June 10, 2026 |
| 12116346 | March 9, 2035 | 002 | Yes | June 10, 2026 | |
| 10329260 | March 9, 2035 | 002 | Yes | June 10, 2026 | |
| 11708333 | March 9, 2035 | 003 | No | U-4535 | June 10, 2026 |
| 11230530 | March 9, 2035 | 003 | No | U-4535 | June 10, 2026 |
| 10689346 | March 9, 2035 | 003 | No | U-4535 | June 10, 2026 |
| 10329260 | March 9, 2035 | 003 | Yes | June 10, 2026 | |
| 12116346 | March 9, 2035 | 003 | Yes | June 10, 2026 | |
| 11708333 | March 9, 2035 | 004 | No | U-4535 | June 10, 2026 |
| 11230530 | March 9, 2035 | 004 | No | U-4535 | June 10, 2026 |
| 10689346 | March 9, 2035 | 004 | No | U-4535 | June 10, 2026 |
| 10329260 | March 9, 2035 | 004 | Yes | June 10, 2026 | |
| 12116346 | March 9, 2035 | 004 | Yes | June 10, 2026 | |
| 10125102 | April 7, 2035 | 001 | Yes | U-4535 | June 10, 2026 |
| 10125102 | April 7, 2035 | 002 | Yes | U-4535 | June 10, 2026 |
| 10125102 | April 7, 2035 | 003 | Yes | U-4535 | June 10, 2026 |
| 10125102 | April 7, 2035 | 004 | Yes | U-4535 | June 10, 2026 |
| 11708333*PED | September 9, 2035 | 001 | No | — | |
| 10329260*PED | September 9, 2035 | 001 | No | — | |
| 12116346*PED | September 9, 2035 | 001 | No | — | |
| 11230530*PED | September 9, 2035 | 001 | No | — | |
| 10689346*PED | September 9, 2035 | 001 | No | — | |
| 11708333*PED | September 9, 2035 | 002 | No | — | |
| 10329260*PED | September 9, 2035 | 002 | No | — | |
| 12116346*PED | September 9, 2035 | 002 | No | — | |
| 11230530*PED | September 9, 2035 | 002 | No | — | |
| 10689346*PED | September 9, 2035 | 002 | No | — | |
| 11708333*PED | September 9, 2035 | 003 | No | — | |
| 10329260*PED | September 9, 2035 | 003 | No | — | |
| 12116346*PED | September 9, 2035 | 003 | No | — | |
| 11230530*PED | September 9, 2035 | 003 | No | — | |
| 10689346*PED | September 9, 2035 | 003 | No | — | |
| 11708333*PED | September 9, 2035 | 004 | No | — | |
| 10329260*PED | September 9, 2035 | 004 | No | — | |
| 12116346*PED | September 9, 2035 | 004 | No | — | |
| 11230530*PED | September 9, 2035 | 004 | No | — | |
| 10689346*PED | September 9, 2035 | 004 | No | — | |
| 10125102*PED | October 7, 2035 | 001 | No | — | |
| 10125102*PED | October 7, 2035 | 002 | No | — | |
| 10125102*PED | October 7, 2035 | 003 | No | — | |
| 10125102*PED | October 7, 2035 | 004 | No | — | |
| 12344585 | November 1, 2039 | 001 | No | U-4535 | June 10, 2026 |
| 11618733 | November 1, 2039 | 001 | No | U-4535 | June 10, 2026 |
| 11117867 | November 1, 2039 | 001 | No | U-4535 | June 10, 2026 |
| 10662160 | November 1, 2039 | 001 | Yes | U-4535 | June 10, 2026 |
| 12590068 | November 1, 2039 | 001 | Yes | April 3, 2026 | |
| 12552750 | November 1, 2039 | 001 | Yes | March 6, 2026 | |
| 12545646 | November 1, 2039 | 001 | Yes | March 6, 2026 | |
| 12545647 | November 1, 2039 | 001 | Yes | March 6, 2026 | |
| 12545645 | November 1, 2039 | 001 | Yes | March 6, 2026 | |
| 12590069 | November 1, 2039 | 001 | Yes | April 3, 2026 | |
| 12344585 | November 1, 2039 | 002 | No | U-4535 | June 10, 2026 |
| 11618733 | November 1, 2039 | 002 | No | U-4535 | June 10, 2026 |
| 11117867 | November 1, 2039 | 002 | No | U-4535 | June 10, 2026 |
| 10662160 | November 1, 2039 | 002 | Yes | U-4535 | June 10, 2026 |
| 12590068 | November 1, 2039 | 002 | Yes | April 3, 2026 | |
| 12545646 | November 1, 2039 | 002 | Yes | March 6, 2026 | |
| 12590069 | November 1, 2039 | 002 | Yes | April 3, 2026 | |
| 12545645 | November 1, 2039 | 002 | Yes | March 6, 2026 | |
| 12545647 | November 1, 2039 | 002 | Yes | March 6, 2026 | |
| 12552750 | November 1, 2039 | 002 | Yes | March 6, 2026 | |
| 12344585 | November 1, 2039 | 003 | No | U-4535 | June 10, 2026 |
| 11618733 | November 1, 2039 | 003 | No | U-4535 | June 10, 2026 |
| 11117867 | November 1, 2039 | 003 | No | U-4535 | June 10, 2026 |
| 10662160 | November 1, 2039 | 003 | Yes | U-4535 | June 10, 2026 |
| 12545646 | November 1, 2039 | 003 | Yes | March 6, 2026 | |
| 12545647 | November 1, 2039 | 003 | Yes | March 6, 2026 | |
| 12545645 | November 1, 2039 | 003 | Yes | March 6, 2026 | |
| 12552750 | November 1, 2039 | 003 | Yes | March 6, 2026 | |
| 12590069 | November 1, 2039 | 003 | Yes | April 3, 2026 | |
| 12590068 | November 1, 2039 | 003 | Yes | April 3, 2026 | |
| 12344585 | November 1, 2039 | 004 | No | U-4535 | June 10, 2026 |
| 11618733 | November 1, 2039 | 004 | No | U-4535 | June 10, 2026 |
| 11117867 | November 1, 2039 | 004 | No | U-4535 | June 10, 2026 |
| 10662160 | November 1, 2039 | 004 | Yes | U-4535 | June 10, 2026 |
| 12590069 | November 1, 2039 | 004 | Yes | April 3, 2026 | |
| 12545645 | November 1, 2039 | 004 | Yes | March 6, 2026 | |
| 12590068 | November 1, 2039 | 004 | Yes | April 3, 2026 | |
| 12545647 | November 1, 2039 | 004 | Yes | March 6, 2026 | |
| 12552750 | November 1, 2039 | 004 | Yes | March 6, 2026 | |
| 12545646 | November 1, 2039 | 004 | Yes | March 6, 2026 | |
| 12590069*PED | May 1, 2040 | 001 | No | — | |
| 12590068*PED | May 1, 2040 | 001 | No | — | |
| 12552750*PED | May 1, 2040 | 001 | No | — | |
| 12545647*PED | May 1, 2040 | 001 | No | — | |
| 12545646*PED | May 1, 2040 | 001 | No | — | |
| 12545645*PED | May 1, 2040 | 001 | No | — | |
| 12344585*PED | May 1, 2040 | 001 | No | — | |
| 11618733*PED | May 1, 2040 | 001 | No | — | |
| 11117867*PED | May 1, 2040 | 001 | No | — | |
| 10662160*PED | May 1, 2040 | 001 | No | — | |
| 12590069*PED | May 1, 2040 | 002 | No | — | |
| 12590068*PED | May 1, 2040 | 002 | No | — | |
| 12552750*PED | May 1, 2040 | 002 | No | — | |
| 12545647*PED | May 1, 2040 | 002 | No | — | |
| 12545646*PED | May 1, 2040 | 002 | No | — | |
| 12545645*PED | May 1, 2040 | 002 | No | — | |
| 12344585*PED | May 1, 2040 | 002 | No | — | |
| 11618733*PED | May 1, 2040 | 002 | No | — | |
| 11117867*PED | May 1, 2040 | 002 | No | — | |
| 10662160*PED | May 1, 2040 | 002 | No | — | |
| 12590069*PED | May 1, 2040 | 003 | No | — | |
| 12590068*PED | May 1, 2040 | 003 | No | — | |
| 12552750*PED | May 1, 2040 | 003 | No | — | |
| 12545647*PED | May 1, 2040 | 003 | No | — | |
| 12545646*PED | May 1, 2040 | 003 | No | — | |
| 12545645*PED | May 1, 2040 | 003 | No | — | |
| 12344585*PED | May 1, 2040 | 003 | No | — | |
| 11618733*PED | May 1, 2040 | 003 | No | — | |
| 11117867*PED | May 1, 2040 | 003 | No | — | |
| 10662160*PED | May 1, 2040 | 003 | No | — | |
| 12590069*PED | May 1, 2040 | 004 | No | — | |
| 12590068*PED | May 1, 2040 | 004 | No | — | |
| 12552750*PED | May 1, 2040 | 004 | No | — | |
| 12545647*PED | May 1, 2040 | 004 | No | — | |
| 12545646*PED | May 1, 2040 | 004 | No | — | |
| 12545645*PED | May 1, 2040 | 004 | No | — | |
| 12344585*PED | May 1, 2040 | 004 | No | — | |
| 11618733*PED | May 1, 2040 | 004 | No | — | |
| 11117867*PED | May 1, 2040 | 004 | No | — | |
| 10662160*PED | May 1, 2040 | 004 | No | — |
| Code | Expires | Product |
|---|---|---|
| NP | December 11, 2028 | 001 |
| NP | December 11, 2028 | 002 |
| NP | December 11, 2028 | 003 |
| NP | December 11, 2028 | 004 |
| PED | June 11, 2029 | 001 |
| PED | June 11, 2029 | 002 |
| PED | June 11, 2029 | 003 |
| PED | June 11, 2029 | 004 |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Type 3 - New Dosage Form | Approved | December 11, 2025 | Priority |
Adverse event reports
Source: openFDA FAERS856
FAERS reports mentioning this drug
A report count is not a risk measure. FAERS accepts voluntary and
mandatory reports without establishing causation, and reporting is influenced by how
widely a drug is used, how long it has been marketed, and media attention. FDA states
that reports “do not prove that the drug caused the event”. Compare rates, not totals.
Attributed to this product's most-reported active ingredient: BEROTRALSTAT HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 72769-111-02 | 72769-111 | BioCryst Pharmaceuticals, Inc. | 4 DOSE PACK in 1 CARTON (72769-111-02) / 7 PACKET in 1 DOSE PACK / 12 PELLET in 1 PACKET | December 12, 2025 |
| 72769-112-02 | 72769-112 | BioCryst Pharmaceuticals, Inc. | 4 DOSE PACK in 1 CARTON (72769-112-02) / 7 PACKET in 1 DOSE PACK / 16 PELLET in 1 PACKET | December 12, 2025 |
| 72769-113-02 | 72769-113 | BioCryst Pharmaceuticals, Inc. | 4 DOSE PACK in 1 CARTON (72769-113-02) / 7 PACKET in 1 DOSE PACK / 18 PELLET in 1 PACKET | December 12, 2025 |
| 72769-114-02 | 72769-114 | BioCryst Pharmaceuticals, Inc. | 4 DOSE PACK in 1 CARTON (72769-114-02) / 7 PACKET in 1 DOSE PACK / 22 PELLET in 1 PACKET | December 12, 2025 |
| 72769-111 | 72769-111 | BioCryst Pharmaceuticals, Inc. | — | December 12, 2025 |
| 72769-112 | 72769-112 | BioCryst Pharmaceuticals, Inc. | — | December 12, 2025 |
| 72769-113 | 72769-113 | BioCryst Pharmaceuticals, Inc. | — | December 12, 2025 |
| 72769-114 | 72769-114 | BioCryst Pharmaceuticals, Inc. | — | December 12, 2025 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.