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).

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