DrugDashboards

Tiopronin

tiopronin · TIOPRONIN 300 mg/1 · Tablet, Delayed Release · Oral · Torrent Pharmaceuticals Limited

NDC 13668-0692-90 · 90 TABLET, DELAYED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

7 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 70709-0123-90) — 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
$68.39per unit
middle half $67.17$69.18 · 161 plans · Apr 1, 2026
Est. net of rebates
≈ $68.39
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
3%of plans cover it
tier 5 · prior auth 12% · 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 4 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
$7,616.48
Reported to Texas DSHS · 2026 annual filing · Torrent Pharmaceuticals

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

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 $5,003.34 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA216990
TE code
AB
Approval date
Jan 30, 2024
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 tiopronin (Tablet, Delayed Release)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals NY LLCTIOPRONIN 300 mg/1Jul 15, 2026Sep 2, 2026
BioComp Pharma, Inc.TIOPRONIN 100 mg/1Jul 15, 2026Sep 2, 2026
BioComp Pharma, Inc.TIOPRONIN 300 mg/1Jul 15, 2026Sep 2, 2026
Cycle Pharmaceuticals Ltd.TIOPRONIN 100 mg/1Jul 15, 2026Sep 2, 2026
Cycle Pharmaceuticals Ltd.TIOPRONIN 300 mg/1Jul 15, 2026Sep 2, 2026
Endo USA, Inc.TIOPRONIN 100 mg/1Jul 15, 2026Sep 2, 2026
Endo USA, Inc.TIOPRONIN 300 mg/1Jul 15, 2026Sep 2, 2026
Mission Pharmacal CompanyTIOPRONIN 100 mg/1Jul 15, 2026Sep 2, 2026
Mission Pharmacal CompanyTIOPRONIN 300 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.TIOPRONIN 100 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.TIOPRONIN 300 mg/1Jul 15, 2026Sep 2, 2026
Torrent Pharmaceuticals LimitedTIOPRONIN 300 mg/1Jul 15, 2026Sep 2, 2026
Torrent Pharmaceuticals LimitedTIOPRONIN 100 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Tiopronin — NDC 13668-0692-90," retrieved September 3, 2026, https://drugdashboards.com/drug/13668069290.

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