Viewing data from:

ROFLUMILAST

ANDA

ROFLUMILAST | A212490 | ALKEM LABORATORIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DALIRESP(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ASTRAZENECA PHARMACEUTICALS LP et al v. ALKEM LABORATORIES LTD. 3:2018cv16399 3 patentsANDA 212490Roflumilast	D.N.J.	2018-11-21	Terminated 2019-11-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$2.00

per ea

Lowest NADAC/Unit

$0.3160

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
67877073093ROFLUMILAST 250 MCG TABLET	$2.00	EA	Generic	—	2026-08-19
67877048090ROFLUMILAST 500 MCG TABLET	$0.3160	EA	Generic	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$238.11

Highest Price

$682.14

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
51407-0975-90ROFLUMILAST 500MCG TAB	$682.14	FSS	Golden State Medical Supply, Inc.	06/14/2028
67877-0730-93ROFLUMILAST 250MCG TAB	$238.11	FSS	Golden State Medical Supply, Inc.	06/14/2028

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
Aug 16, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MCG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 18, 2023

No patent or exclusivity listings for this strength.

#002 — 500MCG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 18, 2023