DrugDashboards

glycerol phenylbutyrate

glycerol phenylbutyrate · GLYCEROL PHENYLBUTYRATE 1.1 g/mL · Liquid · Oral · Lupin Pharmaceuticals, Inc.

NDC 70748-0425-01 · 1 BOTTLE in 1 CARTON / 25 mL in 1 BOTTLE · NDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply.

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 75987-0050-06) — 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ⓘ
$372.01per unit
middle half $372.01–$372.01 · 22 plans · Jan 1, 2026
Est. net of rebatesⓘ
$223.20–$279.01
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
0%of plans cover it
tier 1 · prior auth 100% · 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 9 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Medicaid spend (2026 YTD · Q1)ⓘ

$1.3M
39 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 · avg $85,617.65 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA203284
TE code
AA
Approval date
Feb 1, 2013
Patents / exclusivity
14 patents, 0 exclusivities
TypeNumber / codeExpires
patent9962359Sep 22, 2030
patent9561197Sep 22, 2030
patent10183003Sep 22, 2030
patent10183002Sep 22, 2030
patent10183004Sep 22, 2030
patent8642012Sep 22, 2030
patent10045959Sep 22, 2030
patent9999608Sep 22, 2030
patent9326966Sep 22, 2030
patent10668040Sep 22, 2030
patent10183005Sep 22, 2030
patent10183006Sep 22, 2030

Shortage history

  • Planned discontinuation — RAVICTI, Oral Liquid, 1.1 g/1 mL (NDC 75987-050-06)Sep 1, 2026
  • Planned discontinuation — RAVICTI, Oral Liquid, 1.1 g/1 mL (NDC 75987-050-07)Sep 1, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of glycerol phenylbutyrate (Liquid)

LabelerStrengthFirst seenLast seen
Navinta LLCGLYCEROL PHENYLBUTYRATE 1.1 g/mLJul 16, 2026Sep 3, 2026
Aurobindo Pharma LimitedGLYCEROL PHENYLBUTYRATE 1 kg/kgJul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedGLYCEROL PHENYLBUTYRATE 1.1 g/mLJul 15, 2026Sep 2, 2026
Horizon Therapeutics USA, Inc.GLYCEROL PHENYLBUTYRATE 1.1 g/mLJul 15, 2026Sep 2, 2026
Lupin Manufacturing Solutions LimitedGLYCEROL PHENYLBUTYRATE 1 kg/kgJul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.GLYCEROL PHENYLBUTYRATE 1.1 g/mLJul 15, 2026Sep 2, 2026
MSN Laboratories Private LimitedGLYCEROL PHENYLBUTYRATE 1 kg/kgJul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCGLYCEROL PHENYLBUTYRATE 1.1 g/mLJul 15, 2026Sep 2, 2026
Nuray Chemicals Private LimitedGLYCEROL PHENYLBUTYRATE 35 kg/35kgJul 15, 2026Sep 2, 2026
Penn Pharmaceutical Services LimitedGLYCEROL PHENYLBUTYRATE 1.1 g/mLJul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.GLYCEROL PHENYLBUTYRATE 1.1 g/mLJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.GLYCEROL PHENYLBUTYRATE 1.1 g/mLJul 15, 2026Sep 2, 2026
HAS Healthcare Advanced Synthesis SAGLYCEROL PHENYLBUTYRATE 1 kg/kgJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "glycerol phenylbutyrate — NDC 70748-0425-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70748042501.

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