Viewing data from:

LEFLUNOMIDE

ANDA

LEFLUNOMIDE | A077090 | APOTEX INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ARAVA(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$0.3180

per ea

Lowest NADAC/Unit

$0.3048

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60505250201LEFLUNOMIDE 10 MG TABLET	$0.3180	EA	Generic	—	2026-06-17
50268047715LEFLUNOMIDE 10 MG TABLET	$0.3180	EA	Generic	—	2026-06-17
60505250301LEFLUNOMIDE 20 MG TABLET	$0.3048	EA	Generic	—	2026-06-17
50268047815LEFLUNOMIDE 20 MG TABLET	$0.3048	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$11.29

Highest Price

$20.90

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60505-2502-01LEFLUNOMIDE 10MG TAB	$20.90	FSS	AvKare, LLC	06/14/2028
60505-2503-01LEFLUNOMIDE 20MG TAB	$18.35	FSS	AvKare, LLC	06/14/2028
42291-0420-30LEFLUNOMIDE 10MG TAB	$16.53	FSS	AvKare, LLC	06/14/2028
42291-0421-30LEFLUNOMIDE 20MG TAB	$11.29	FSS	AvKare, LLC	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain7 active DMFs1 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

EUROAPI GERMANY GMBHLEFLUNOMIDE

DMF 81161989

FORMOSA LABORATORIES INCLEFLUNOMIDE

DMF 160382002

CIPLA LTDLEFLUNOMIDE USP

DMF 161092002

ALEMBIC PHARMACEUTICALS LTDLEFLUNOMIDE USP

DMF 161122002

EMCURE PHARMACEUTICALS LTDLEFLUNOMIDE USP

DMF 161242002

MAPRIMED SALEFLUNOMIDE

DMF 329882018

RAKSHIT DRUGS PRIVATE LTDLEFLUNOMIDE

DMF 435802026

UNICHEM LABORATORIES LTDInactiveLEFLUNOMIDE

DMF 165042003

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 15, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 13, 2005

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 13, 2005