The short version
11 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Tolvaptan
Tolvaptan · TOLVAPTAN 15 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC 31722-0868-01 · 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 49884-0768-54) — 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ⓘ
$146.01per unit
middle half $106.45–$229.83 · 2,566 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $146.01
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
47%of plans cover it
tier 5 · prior auth 94% · step therapy 0% · qty limit 65%
*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)
0.0%chance of a new FDA shortage posting for tolvaptan (oral solid) in the next 90 days
sole-source market
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
- analysis · 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 2 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $3,935.41 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Tolvaptan for ADPKD Shared System REMS Shared System REMS
Regulatory
- Application
- ANDA205646
- TE code
- AB1
- Approval date
- Jul 16, 2021
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Tolvaptan (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Ascend Laboratories, LLC | TOLVAPTAN 60 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Ascend Laboratories, LLC | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Ascend Laboratories, LLC | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | TOLVAPTAN 60 mg/1 | Jul 23, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | TOLVAPTAN 45 mg/1 | Jul 23, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | TOLVAPTAN 15 mg/1 | Jul 23, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | TOLVAPTAN 30 mg/1 | Jul 23, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | TOLVAPTAN 90 mg/1 | Jul 23, 2026 | Sep 3, 2026 |
| Apotex Corp. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Apotex Corp. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | TOLVAPTAN 90 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | TOLVAPTAN 45 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Northstar Rx LLC | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Northstar Rx LLC | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka America Pharmaceutical, Inc. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka Pharmaceutical Co., Ltd. | TOLVAPTAN 90 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka Pharmaceutical Co., Ltd. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka Pharmaceutical Co., Ltd. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka Pharmaceutical Co., Ltd. | TOLVAPTAN 45 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Otsuka Pharmaceutical Co., Ltd. | TOLVAPTAN 60 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Par Health USA, LLC | TOLVAPTAN 15 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Par Health USA, LLC | TOLVAPTAN 30 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Otsuka America Pharmaceutical, Inc. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Endo USA, Inc. | TOLVAPTAN 15 mg/1 | Jul 15, 2026 | Aug 19, 2026 |
| Endo USA, Inc. | TOLVAPTAN 30 mg/1 | Jul 15, 2026 | Aug 19, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Tolvaptan — NDC 31722-0868-01," retrieved September 3, 2026, https://drugdashboards.com/drug/31722086801.
Free to cite with attribution — see how the data is put together.