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.
Xenleta
lefamulin acetate · LEFAMULIN ACETATE 150 mg/15mL · Injection, Solution · Intravenous · Meitheal Pharmaceuticals Inc.
NDC 71288-0039-16 · 6 VIAL, SINGLE-USE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-USE · 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 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA211673
- TE code
- —
- Approval date
- Aug 19, 2019
- Patents / exclusivity
- 3 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | GAIN | Aug 19, 2029 |
| exclusivity | NCE | Aug 19, 2024 |
| patent | 12121582 | Jun 14, 2036 |
| patent | 8071643 | Mar 25, 2033 |
| patent | 8153689 | Mar 19, 2028 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of lefamulin acetate (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Meitheal Pharmaceuticals Inc. | LEFAMULIN ACETATE 150 mg/15mL | Jul 24, 2026 | Aug 28, 2026 |
| Patheon Italia S.p.A. | LEFAMULIN ACETATE 150 mg/15mL | Jul 15, 2026 | Aug 26, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Xenleta — NDC 71288-0039-16," retrieved September 3, 2026, https://drugdashboards.com/drug/71288003916.
Free to cite with attribution — see how the data is put together.