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.
Auvelity
dextromethorphan hydrobromide, bupropion hydrochloride · DEXTROMETHORPHAN HYDROBROMIDE 45 mg/1; BUPROPION HYDROCHLORIDE 105 mg/1 · Tablet, Multilayer, Extended Release · Oral · Axsome Therapeutics, Inc.
NDC 81968-0045-31 · 1 BOTTLE in 1 CARTON / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 81968-0045-30) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
Data sources
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method
Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
Plans pay at point of saleⓘ
$19.97per unit
middle half $19.71–$20.78 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
$11.98–$14.98
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 38% · step therapy 36% · qty limit 77%
*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.
NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for dextromethorphan hydrobromide, bupropion hydrochloride (oral solid) in the next 90 days
sole-source market · price up 6% YoY
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- Dipharma Francis SrlItalyapi manufacture
- api manufacture
- Patheon Inc.Canadamanufacture
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 $1,054.69 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA215430
- TE code
- —
- Approval date
- Aug 18, 2022
- Patents / exclusivity
- 204 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | I-913 | Apr 30, 2029 |
| exclusivity | I-913 | Apr 30, 2029 |
| patent | 12653795 | Nov 28, 2043 |
| patent | 12194036 | Apr 20, 2043 |
| patent | 11844797 | Apr 20, 2043 |
| patent | 11839612 | Mar 2, 2043 |
| patent | 12042473 | Feb 23, 2043 |
| patent | 12146889 | Feb 23, 2043 |
| patent | 11752144 | Feb 23, 2043 |
| patent | 12472155 | Feb 23, 2043 |
| patent | 11986444 | Feb 15, 2043 |
| patent | 12370154 | Feb 15, 2043 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of dextromethorphan hydrobromide, bupropion hydrochloride (Tablet, Multilayer, Extended Release)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Axsome Therapeutics, Inc. | DEXTROMETHORPHAN HYDROBROMIDE 30 mg/1; BUPROPION HYDROCHLORIDE 105 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Axsome Therapeutics, Inc. | DEXTROMETHORPHAN HYDROBROMIDE 45 mg/1; BUPROPION HYDROCHLORIDE 105 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Axsome Therapeutics, Inc. | DEXTROMETHORPHAN HYDROBROMIDE 105 mg/1; BUPROPION HYDROCHLORIDE 30 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Axsome Therapeutics, Inc. | DEXTROMETHORPHAN HYDROBROMIDE 105 mg/1; BUPROPION HYDROCHLORIDE 45 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Axsome Therapeutics, Inc. | BUPROPION HYDROCHLORIDE 105 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 30 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Axsome Therapeutics, Inc. | BUPROPION HYDROCHLORIDE 105 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 45 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Auvelity — NDC 81968-0045-31," retrieved September 3, 2026, https://drugdashboards.com/drug/81968004531.
Free to cite with attribution — see how the data is put together.