Prescription medicine
Berotralstat Brand names: Orladeyo
Berotralstat (Orladeyo) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the berotralstat FDA label on DailyMed (effective August 20, 2026, BioCryst Pharmaceuticals, Inc.); the NDA 214094 record on Drugs@FDA; every berotralstat label on DailyMed.
Highlights of the record
FDA label of August 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageORLADEYO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years of age and older.
Forms and strengths
- 72 mg
- 96 mg
- 108 mg
- 110 mg
- 132 mg
- 150 mg
Pellet; capsule.
On the market
- Earliest approval on file
- December 3, 2020 Orladeyo, Biocryst; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 1, 2040 Orladeyo pellets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 856 through July 30, 2026
What is berotralstat used for?
From the label: indications and usageORLADEYO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years of age and older. ORLADEYO is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years and older. ( 1 ) Limitations of Use: ORLADEYO should not be used for treatment of acute HAE attacks. ( 1 ) Limitations of Use: The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for treatment of acute HAE attacks. […]
FDA pharmacologic class: Plasma Kallikrein Inhibitor.
Source: FDA drug label (Orladeyo), BioCryst Pharmaceuticals, Inc., effective August 20, 2026 (SPL set 3527ece1-e7e0-40b1-b0c5-6baeb0deabeb), via openFDA; the full label on DailyMed
Is there a generic for berotralstat (Orladeyo)?
No generic berotralstat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 16 patents for Orladeyo pellets: the compound patent runs to November 1, 2039 (pediatric exclusivity to May 1, 2040). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the berotralstat label say about other medicines?
The berotralstat label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Etonogestrel | drug interactions | Desogestrel Concomitant use of ORLADEYO with desogestrel increases exposure to etonogestrel, the active metabolite of desogestrel, and may increase the risk of desogestrel-associated adverse reactions. |
Source: FDA drug label (Orladeyo), BioCryst Pharmaceuticals, Inc., effective August 20, 2026 (SPL set 3527ece1-e7e0-40b1-b0c5-6baeb0deabeb), via openFDA; the full label on DailyMed
What do FAERS reports show for berotralstat?
The FDA Adverse Event Reporting System holds 856 reports that list berotralstat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 28 are coded as a death and 209 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other plasma kallikrein inhibitors
- the pharmacologic class, with prices and generics
- Berotralstat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other