DrugDashboards

Teriflunomide

Teriflunomide · TERIFLUNOMIDE 14 mg/1 · Tablet, Film Coated · Oral · Zydus Pharmaceuticals USA Inc.

NDC 70710-1115-08 · 2 CARTON in 1 CARTON / 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK · ANDA · View full market →

The short version

15 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 31722-0247-30) — 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ⓘ
$3.65per unit
middle half $1.54–$44.67 · 4,294 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $3.65
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
78%of plans cover it
tier 4 · prior auth 74% · step therapy 0% · qty limit 95%

*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 teriflunomide (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market

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

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 $1,466.04 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA209668
TE code
AB
Approval date
Nov 30, 2018
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 Teriflunomide (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Msn Laboratories Private LimitedTERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 3, 2026
Accord Healthcare Inc.TERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.TERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.TERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.TERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedTERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedTERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
AvKARETERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
AvKARETERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
Biocon Pharma Inc.TERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Biocon Pharma Inc.TERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
Concord Biotech LimitedTERIFLUNOMIDE 14 mg/141Jul 15, 2026Sep 2, 2026
Concord Biotech LimitedTERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Genzyme CorporationTERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
Genzyme CorporationTERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USATERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USATERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.TERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.TERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.TERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.TERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedTERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedTERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.TERIFLUNOMIDE 7 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.TERIFLUNOMIDE 14 mg/1Jul 15, 2026Sep 2, 2026
Opella Healthcare International SasTERIFLUNOMIDE 7 mg/1Jul 15, 2026Aug 31, 2026
Opella Healthcare International SasTERIFLUNOMIDE 14 mg/1Jul 15, 2026Aug 31, 2026
Msn Laboratories Private LimitedTERIFLUNOMIDE 7 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Teriflunomide — NDC 70710-1115-08," retrieved September 3, 2026, https://drugdashboards.com/drug/70710111508.

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