The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Orladeyo
Berotralstat hydrochloride · BEROTRALSTAT HYDROCHLORIDE 132 mg/1 · Pellet · Oral · BioCryst Pharmaceuticals, Inc.
NDC 72769-0114-02 · 4 DOSE PACK in 1 CARTON / 7 PACKET in 1 DOSE PACK / 22 PELLET in 1 PACKET · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Estimated fill cost
WAC per package, as filed
$48,487.92
Reported to Texas DSHS · 2026 annual filing · BioCryst Pharmaceuticals, Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Avista Pharma Solutions, Inc. dba CambrexUnited Statesanalysis
- Halo Pharmaceutical IncUnited Stateslabel · pack
- Quotient Sciences - Philadelphia, LLCUnited Statesanalysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $42,449.43 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA219776
- TE code
- —
- Approval date
- Dec 11, 2025
- Patents / exclusivity
- 128 patents, 8 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | PED | Jun 11, 2029 |
| exclusivity | PED | Jun 11, 2029 |
| exclusivity | PED | Jun 11, 2029 |
| exclusivity | PED | Jun 11, 2029 |
| exclusivity | NP | Dec 11, 2028 |
| exclusivity | NP | Dec 11, 2028 |
| exclusivity | NP | Dec 11, 2028 |
| exclusivity | NP | Dec 11, 2028 |
| patent | 11618733*PED | May 1, 2040 |
| patent | 12590069*PED | May 1, 2040 |
| patent | 12590069*PED | May 1, 2040 |
| patent | 12590069*PED | May 1, 2040 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Berotralstat hydrochloride (Pellet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| BioCryst Pharmaceuticals, Inc. | BEROTRALSTAT HYDROCHLORIDE 108 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| BioCryst Pharmaceuticals, Inc. | BEROTRALSTAT HYDROCHLORIDE 132 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| BioCryst Pharmaceuticals, Inc. | BEROTRALSTAT HYDROCHLORIDE 72 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| BioCryst Pharmaceuticals, Inc. | BEROTRALSTAT HYDROCHLORIDE 96 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Orladeyo — NDC 72769-0114-02," retrieved September 3, 2026, https://drugdashboards.com/drug/72769011402.
Free to cite with attribution — see how the data is put together.