The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Byfavo
remimazolam besylate · REMIMAZOLAM BESYLATE 2.5 mg/mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Acacia Pharma, Ltd.
NDC 71390-0011-11 · 10 VIAL in 1 CARTON / 8 mL in 1 VIAL · 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
$438.20
Reported to Texas DSHS · 2026 annual filing · Acacia Pharma Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2025)
$23,725
305 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Cambrex Karlskoga ABSwedenanalysis · api manufacture
- Cosmo SpAItalyanalysis · manufacture
- analysis
- ITS Testing Services (UK) LimitedUnited Kingdomanalysis
- Particle Analytical ApSDenmarkanalysis
- analysis · manufacture · pack
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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA212295
- TE code
- —
- Approval date
- Oct 6, 2020
- Patents / exclusivity
- 11 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 9827251 | Jan 13, 2034 |
| patent | 9561236 | Apr 30, 2033 |
| patent | 10052334 | Nov 7, 2031 |
| patent | 10195210 | Nov 7, 2031 |
| patent | 10342800 | Nov 7, 2031 |
| patent | 9737547 | Nov 7, 2031 |
| patent | 10722522 | Nov 7, 2031 |
| patent | 9914738 | Jul 10, 2027 |
| patent | 10472365 | Jul 10, 2027 |
| patent | 9777007 | Jul 10, 2027 |
| patent | 10961250 | Jul 10, 2027 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of remimazolam besylate (Injection, Powder, Lyophilized, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Acacia Pharma, Ltd. | REMIMAZOLAM BESYLATE 2.5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Patheon Italia S.p.A. | REMIMAZOLAM BESYLATE 2.5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Byfavo — NDC 71390-0011-11," retrieved September 3, 2026, https://drugdashboards.com/drug/71390001111.
Free to cite with attribution — see how the data is put together.