The short version
6 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Myrbetriq
mirabegron · MIRABEGRON 50 mg/1 · Tablet, Film Coated, Extended Release · Oral · Astellas Pharma US, Inc.
NDC 00469-2602-07 · 4 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 00469-2602-30) — 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ⓘ
$14.85per unit
middle half $14.67–$15.56 · 4,391 plans · Apr 1, 2026
Est. net of rebatesⓘ
$8.91–$11.14
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
80%of plans cover it
tier 3 · prior auth 0% · step therapy 0% · qty limit 67%
*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 mirabegron (oral solid) in the next 90 days
sole-source market · 1 Class I/II recall(s) in 12 months
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 · api manufacture
- Astellas Pharma Inc.Japananalysis · api manufacture
- api manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- NDA202611
- TE code
- AB
- Approval date
- Jun 28, 2012
- Patents / exclusivity
- 20 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 10842780*PED | Mar 28, 2030 |
| patent | 10842780*PED | Mar 28, 2030 |
| patent | 12059409*PED | Mar 28, 2030 |
| patent | 12059409*PED | Mar 28, 2030 |
| patent | 11707451*PED | Mar 28, 2030 |
| patent | 11707451*PED | Mar 28, 2030 |
| patent | 12097189*PED | Mar 28, 2030 |
| patent | 12097189*PED | Mar 28, 2030 |
| patent | 12059409 | Sep 28, 2029 |
| patent | 12059409 | Sep 28, 2029 |
| patent | 10842780 | Sep 28, 2029 |
| patent | 10842780 | Sep 28, 2029 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of mirabegron (Tablet, Film Coated, Extended Release)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Bryant Ranch Prepack | MIRABEGRON 25 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | MIRABEGRON 50 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Amneal Pharmaceuticals NY LLC | MIRABEGRON 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | MIRABEGRON 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Astellas Pharma US, Inc. | MIRABEGRON 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Astellas Pharma US, Inc. | MIRABEGRON 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | MIRABEGRON 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | MIRABEGRON 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Qilu Pharmaceutical Co., Ltd. | MIRABEGRON 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Qilu Pharmaceutical Co., Ltd. | MIRABEGRON 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Remedyrepack Inc. | MIRABEGRON 50 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, "Myrbetriq — NDC 00469-2602-07," retrieved September 3, 2026, https://drugdashboards.com/drug/00469260207.
Free to cite with attribution — see how the data is put together.