The short version
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Lytgobi
Lytgobi · Kit · Taiho Pharmaceutical Co., Ltd.
NDC 64842-0128-08 · 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK · 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.
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 $22,935.99 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA214801
- TE code
- —
- Approval date
- Sep 30, 2022
- Patents / exclusivity
- 6 patents, 4 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | ODE-410 | Sep 30, 2029 |
| exclusivity | ODE* | Sep 30, 2029 |
| exclusivity | NCE | Sep 30, 2027 |
| exclusivity | NCE | Sep 30, 2027 |
| patent | 11833151 | Nov 5, 2039 |
| patent | 11833151 | Nov 5, 2039 |
| patent | 10434103 | Mar 31, 2036 |
| patent | 10434103 | Mar 31, 2036 |
| patent | 9108973 | Feb 13, 2033 |
| patent | 9108973 | Feb 13, 2033 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Lytgobi (Kit)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Taiho Pharmaceutical Co., Ltd. | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Lytgobi — NDC 64842-0128-08," retrieved September 3, 2026, https://drugdashboards.com/drug/64842012808.
Free to cite with attribution — see how the data is put together.