DrugDashboards

Sapropterin dihydrochloride

Sapropterin dihydrochloride · SAPROPTERIN DIHYDROCHLORIDE 500 mg/1 · Powder, For Solution · Oral · Camber Pharmaceuticals, Inc.

NDC 31722-0048-30 · 30 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET · ANDA · View full market →

The short version

8 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 49884-0873-72) — 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ⓘ
$115.34per unit
middle half $107.79–$141.45 · 3,867 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $115.34
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
70%of plans cover it
tier 5 · prior auth 72% · step therapy 0% · qty limit 0%

*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.

Estimated fill cost

WAC per package, as filed
$4,080.00
Reported to Texas DSHS · 2026 annual filing · Annora Pharma Private Ltd.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2025)

$1.8M
305 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

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 $7,749.86 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA215420
TE code
AB
Approval date
Aug 18, 2022
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Sapropterin dihydrochloride (Powder, For Solution)

LabelerStrengthFirst seenLast seen
Aucta Pharmaceuticals, Inc.SAPROPTERIN DIHYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Aucta Pharmaceuticals, Inc.SAPROPTERIN DIHYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
BioMarin Pharmaceutical Inc.SAPROPTERIN DIHYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
BioMarin Pharmaceutical Inc.SAPROPTERIN DIHYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.SAPROPTERIN DIHYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.SAPROPTERIN DIHYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories IncSAPROPTERIN DIHYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories IncSAPROPTERIN DIHYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Micro Labs LimitedSAPROPTERIN DIHYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Micro Labs LimitedSAPROPTERIN DIHYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCSAPROPTERIN DIHYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCSAPROPTERIN DIHYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Par Health USA, LLCSAPROPTERIN DIHYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Par Health USA, LLCSAPROPTERIN DIHYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Trupharma, LlcSAPROPTERIN DIHYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Trupharma, LlcSAPROPTERIN DIHYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Sapropterin dihydrochloride — NDC 31722-0048-30," retrieved September 3, 2026, https://drugdashboards.com/drug/31722004830.

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