Viewing data from:

DALIRESP

NDA

ROFLUMILAST | N022522 | ASTRAZENECA PHARMACEUTICALS LP

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
ASTRAZENECA PHARMACEUTICALS LP et al v. AUROBINDO PHARMA LIMITED et al 3:2019cv12567 3 patentsANDA 213298Roflumilast	D.N.J.	2019-05-15	Terminated 2020-02-07	—
ASTRAZENECA PHARMACEUTICALS LP et al v. ALKEM LABORATORIES LTD. 3:2018cv16399 3 patentsANDA 212490Roflumilast	D.N.J.	2018-11-21	Terminated 2019-11-12	—
ASTRAZENECA AB et al v. TORRENT PHARMA INC. et al 3:2016cv02091 1 patentANDA 208272roflumilast	D.N.J.	2016-04-13	Terminated 2017-09-29	—
ASTRAZENECA AB et al v. APOTEX CORP. et al 3:2015cv03379 3 patentsANDA 208304roflumilast	D.N.J.	2015-05-15	Terminated 2017-06-05	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Daliresp (2023)

Total Spending

$28.6M

Total Claims

52,932

Beneficiaries

14,896

Avg Cost/Unit

$14.16

Spending Trend

$173.6M(2019)→$189.7M(2020)→$199.1M(2021)→$181.4M(2022)→$28.6M(2023)

YoY Change:-2.5%

5yr CAGR:+3.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

5 letters from Drugs@FDA

Date	Submission	Document
Jan 25, 2018	SUPPL -9	View Letter (PDF)
Sep 1, 2017	SUPPL -8	View Letter (PDF)
Nov 25, 2015	SUPPL -6	View Letter (PDF)
Aug 27, 2013	SUPPL -3	View Letter (PDF)
Mar 7, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MCG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 28, 2011

No patent or exclusivity listings for this strength.

#002 — 250MCG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 23, 2018