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.
Tirosint SOL
Levothyroxine Sodium · LEVOTHYROXINE SODIUM 50 ug/mL · Solution · Oral · IBSA Pharma Inc.
NDC 71858-0115-02 · 6 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH / 1 mL in 1 AMPULE · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 71858-0115-05) — 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ⓘ
$5.07per unit
middle half $4.99–$5.16 · 50 plans · Apr 1, 2026
Est. net of rebatesⓘ
$3.04–$3.80
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
1%of plans cover it
tier 4 · prior auth 2% · step therapy 0% · qty limit 8%
*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 levothyroxine sodium (other) 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 →
Regulatory
- Application
- NDA206977
- TE code
- —
- Approval date
- Dec 15, 2016
- Patents / exclusivity
- 60 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 12564565 | Sep 26, 2044 |
| patent | 12564565 | Sep 26, 2044 |
| patent | 12564565 | Sep 26, 2044 |
| patent | 12564565 | Sep 26, 2044 |
| patent | 12564565 | Sep 26, 2044 |
| patent | 12564565 | Sep 26, 2044 |
| patent | 12564565 | Sep 26, 2044 |
| patent | 12564565 | Sep 26, 2044 |
| patent | 12564565 | Sep 26, 2044 |
| patent | 12564565 | Sep 26, 2044 |
| patent | 12564565 | Sep 26, 2044 |
| patent | 12564565 | Sep 26, 2044 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
- Class II · TerminatedJan 30, 2023IBSA PHARMA INC — Subpotent Drug
Manufacturers of Levothyroxine Sodium (Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 88 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 100 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 112 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 125 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 13 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 137 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 150 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 175 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 200 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 25 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 62.5 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 75 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 37.5 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 44 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| IBSA Pharma Inc. | LEVOTHYROXINE SODIUM 50 ug/mL | Jul 15, 2026 | Sep 2, 2026 |
| Oliva Therapeutics, LLC | LEVOTHYROXINE SODIUM 100 ug/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Viatris Specialty LLC | LEVOTHYROXINE SODIUM 30 ug/mL | Jul 15, 2026 | Jul 29, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Tirosint SOL — NDC 71858-0115-02," retrieved September 3, 2026, https://drugdashboards.com/drug/71858011502.
Free to cite with attribution — see how the data is put together.