The short version
Just 3 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.
Kyzatrex
Testosterone Undecanoate · TESTOSTERONE UNDECANOATE 200 mg/1 · Capsule, Liquid Filled · Oral · Marius Pharmaceuticals
NDC 80603-0105-11 · 90 CAPSULE, LIQUID FILLED in 1 BOTTLE · 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.
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 testosterone undecanoate (oral solid) in the next 90 days
sole-source market · price up 4% 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 →
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 $1,110.91 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Aveed
Regulatory
- Application
- NDA213953
- TE code
- —
- Approval date
- Jul 27, 2022
- Patents / exclusivity
- 18 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 12403146 | Mar 29, 2041 |
| patent | 12403146 | Mar 29, 2041 |
| patent | 12403146 | Mar 29, 2041 |
| patent | 11617758 | Mar 15, 2033 |
| patent | 11617758 | Mar 15, 2033 |
| patent | 11617758 | Mar 15, 2033 |
| patent | 12357643 | Mar 15, 2033 |
| patent | 12357643 | Mar 15, 2033 |
| patent | 12357643 | Mar 15, 2033 |
| patent | 10576089 | Dec 31, 2030 |
| patent | 10576089 | Dec 31, 2030 |
| patent | 10576089 | Dec 31, 2030 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Testosterone Undecanoate (Capsule, Liquid Filled)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Marius Pharmaceuticals | TESTOSTERONE UNDECANOATE 50 mg/1 | Sep 3, 2026 | Sep 3, 2026 |
| Marius Pharmaceuticals | TESTOSTERONE UNDECANOATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Marius Pharmaceuticals | TESTOSTERONE UNDECANOATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| TOLMAR Inc. | TESTOSTERONE UNDECANOATE 198 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| TOLMAR Inc. | TESTOSTERONE UNDECANOATE 158 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| TOLMAR Inc. | TESTOSTERONE UNDECANOATE 237 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Verity Pharmaceuticals Inc. | TESTOSTERONE UNDECANOATE 112.5 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, "Kyzatrex — NDC 80603-0105-11," retrieved September 3, 2026, https://drugdashboards.com/drug/80603010511.
Free to cite with attribution — see how the data is put together.