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ROFLUMILAST

ANDA

ROFLUMILAST | A208256 | MSN LABORATORIES PRIVATE LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DALIRESP(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 8 NDCs

Highest NADAC/Unit

$1.91

per ea

Lowest NADAC/Unit

$0.3204

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
72205020124ROFLUMILAST 250 MCG TABLET	$1.91	EA	Generic	—	2026-06-17
72205020132ROFLUMILAST 250 MCG TABLET	$1.91	EA	Generic	—	2026-06-17
00904749371ROFLUMILAST 250 MCG TABLET	$1.91	EA	Generic	—	2026-06-17
72205020090ROFLUMILAST 500 MCG TABLET	$0.3204	EA	Generic	—	2026-06-17
00904748303ROFLUMILAST 500 MCG TABLET	$0.3204	EA	Generic	—	2026-06-17
00904739946ROFLUMILAST 500 MCG TABLET	$0.3204	EA	Generic	—	2026-06-17
00904748389ROFLUMILAST 500 MCG TABLET	$0.3204	EA	Generic	—	2026-06-17
72205020030ROFLUMILAST 500 MCG TABLET	$0.3204	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 | 3 NDCs (3 FSS)

Lowest Price

$197.01

Highest Price

$844.20

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00904-7483-03ROFLUMILAST 500MCG TAB	$296.36	FSS	The Harvard Drug Group L.L.C. dba Major Pharmaceuticals and Rugby Labs	05/31/2030
00904-7483-89ROFLUMILAST 500MCG TAB	$844.20	FSS	The Harvard Drug Group L.L.C. dba Major Pharmaceuticals and Rugby Labs	05/31/2030
00904-7493-71ROFLUMILAST 250MCG TAB	$197.01	FSS	The Harvard Drug Group L.L.C. dba Major Pharmaceuticals and Rugby Labs	05/31/2030

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

API Supply Chain13 active DMFs

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

SCINOPHARM TAIWAN LTDROFLUMILAST

DMF 267642012

MSN LABORATORIES PRIVATE LTDROFLUMILAST [ROUTE CODE - RO"]

DMF 276122013

ALP PHARM BEIJING CO LTDROFLUMILAST

DMF 277792014

MATRIX PHARMACORP PRIVATE LTDROFLUMILAST

DMF 284402014

INTERQUIM SAROFLUMILAST

DMF 284712014

CHONGQING HUAPONT PHARMACEUTICAL CO LTDROFLUMILAST

DMF 285062014

HETERO DRUGS LTDROFLUMILAST

DMF 285162014

ZYDUS LIFESCIENCES LTDROFLUMILAST USP

DMF 286572014

VERANOVA LPROFLUMILAST

DMF 320932017

APITORIA PHARMA PRIVATE LTDROFLUMILAST

DMF 328512018

TORRENT PHARMACEUTICALS LTDROFLUMILAST

DMF 356612021

HEFEI TIANRUI PHARMACEUTICAL CHEMICAL CO LTDROFLUMILAST

DMF 393172023

ALIVUS LIFE SCIENCES LTDROFLUMILAST USP

DMF 397812024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 28, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MCG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 7, 2022

No patent or exclusivity listings for this strength.

#002 — 500MCG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 7, 2022