DrugDashboards

Rexulti

brexpiprazole · BREXPIPRAZOLE 2 mg/1 · Tablet · Oral · Otsuka America Pharmaceutical, Inc.

NDC 59148-0038-07 · 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK · NDA · View full market →

The short version

5 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.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 59148-0038-13) — 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ⓘ
$51.03per unit
middle half $49.60–$52.59 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
$30.62–$38.27
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 31% · step therapy 2% · qty limit 96%

*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 brexpiprazole (oral solid) in the next 90 days

sole-source market · price up 3% 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 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $1,439.27 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA205422
TE code
AB
Approval date
Jul 10, 2015
Patents / exclusivity
58 patents, 24 exclusivities
TypeNumber / codeExpires
exclusivityM-315May 9, 2028
exclusivityM-315May 9, 2028
exclusivityM-315May 9, 2028
exclusivityM-315May 9, 2028
exclusivityM-315May 9, 2028
exclusivityM-315May 9, 2028
exclusivityPEDNov 8, 2027
exclusivityPEDNov 8, 2027
exclusivityPEDNov 8, 2027
exclusivityPEDNov 8, 2027
exclusivityPEDNov 8, 2027
exclusivityPEDNov 8, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of brexpiprazole (Tablet)

LabelerStrengthFirst seenLast seen
Ajanta Pharma USA Inc.BREXPIPRAZOLE 4 mg/1Jul 15, 2026Sep 2, 2026
Ajanta Pharma USA Inc.BREXPIPRAZOLE 2 mg/1Jul 15, 2026Sep 2, 2026
Ajanta Pharma USA Inc.BREXPIPRAZOLE 1 mg/1Jul 15, 2026Sep 2, 2026
Ajanta Pharma USA Inc.BREXPIPRAZOLE .25 mg/1Jul 15, 2026Sep 2, 2026
Ajanta Pharma USA Inc.BREXPIPRAZOLE .5 mg/1Jul 15, 2026Sep 2, 2026
Ajanta Pharma USA Inc.BREXPIPRAZOLE 3 mg/1Jul 15, 2026Sep 2, 2026
Otsuka America Pharmaceutical, Inc.BREXPIPRAZOLE 3 mg/1Jul 15, 2026Sep 2, 2026
Otsuka America Pharmaceutical, Inc.BREXPIPRAZOLE .5 mg/1Jul 15, 2026Sep 2, 2026
Otsuka America Pharmaceutical, Inc.BREXPIPRAZOLE 4 mg/1Jul 15, 2026Sep 2, 2026
Otsuka America Pharmaceutical, Inc.BREXPIPRAZOLE 1 mg/1Jul 15, 2026Sep 2, 2026
Otsuka America Pharmaceutical, Inc.BREXPIPRAZOLE .25 mg/1Jul 15, 2026Sep 2, 2026
Otsuka America Pharmaceutical, Inc.BREXPIPRAZOLE 2 mg/1Jul 15, 2026Sep 2, 2026
Otsuka Pharmaceutical Co., Ltd.BREXPIPRAZOLE .5 mg/1Jul 15, 2026Sep 2, 2026
Otsuka Pharmaceutical Co., Ltd.BREXPIPRAZOLE 4 mg/1Jul 15, 2026Sep 2, 2026
Otsuka Pharmaceutical Co., Ltd.BREXPIPRAZOLE 3 mg/1Jul 15, 2026Sep 2, 2026
Otsuka Pharmaceutical Co., Ltd.BREXPIPRAZOLE .25 mg/1Jul 15, 2026Sep 2, 2026
Otsuka Pharmaceutical Co., Ltd.BREXPIPRAZOLE 1 mg/1Jul 15, 2026Sep 2, 2026
Otsuka Pharmaceutical Co., Ltd.BREXPIPRAZOLE 2 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.BREXPIPRAZOLE 2 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.BREXPIPRAZOLE 1 mg/1Jul 15, 2026Sep 2, 2026
Societal CDMO Gainesville, LLCBREXPIPRAZOLE 1 mg/1Jul 15, 2026Sep 2, 2026
Societal CDMO Gainesville, LLCBREXPIPRAZOLE 4 mg/1Jul 15, 2026Sep 2, 2026
Societal CDMO Gainesville, LLCBREXPIPRAZOLE 3 mg/1Jul 15, 2026Sep 2, 2026
Societal CDMO Gainesville, LLCBREXPIPRAZOLE 2 mg/1Jul 15, 2026Sep 2, 2026
Societal CDMO Gainesville, LLCBREXPIPRAZOLE .5 mg/1Jul 15, 2026Sep 2, 2026
Societal CDMO Gainesville, LLCBREXPIPRAZOLE .25 mg/1Jul 15, 2026Sep 2, 2026
Pharma Packaging Solutions, LLC dba Tjoapack LLCBREXPIPRAZOLE 2 mg/1Jul 15, 2026Jul 22, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Rexulti — NDC 59148-0038-07," retrieved September 3, 2026, https://drugdashboards.com/drug/59148003807.

Free to cite with attribution — see how the data is put together.