Petition	Type	Filed	Status	Petitioner
Physicians for Integrity in Medical Research, Inc. - Citizen Petition FDA-2011-P-0768 · 8 docket documents Physicians for Integrity in Medical Research, Inc. filed this citizen petition under 21 CFR 10.30 on October 16, 2011, requesting that the FDA revoke its approval of roflumilast (Deliresp) for severe chronic obstructive pulmonary disease, which was approved on February 28, 2011. The petitioner conte	Other	2011-11-02	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

76 trials from ClinicalTrials.gov, 61 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)NCT00108823	Phase 3	Completed	AstraZeneca	550	2004-10
A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:NCT01313494	Phase 3	Completed	AstraZeneca	626	2011-03 → 2012-05
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)NCT01443845	Phase 4	Completed	AstraZeneca	2,354	2011-09-30 → 2016-01-31
Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)NCT00424268	Phase 3	Completed	AstraZeneca	743	2007-01 → 2008-07
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)NCT00246935	Phase 3	Completed	AstraZeneca	150	2005-05 → 2007-10
Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis NCT03764475	Phase 2	Completed	Arcutis Biotherapeutics, Inc.	332	2018-12-18 → 2020-10-08
Topical Roflumilast in Adults With Atopic Dermatitis NCT01856764	Phase 2	Completed	AstraZeneca	40	2013-06 → 2014-03
Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis NCT04128007	Phase 2	Completed	Arcutis Biotherapeutics, Inc.	304	2020-01-13 → 2020-09-25
Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization NCT01973998	Phase 3	Completed	Temple University	68	2013-11 → 2017-11-30
PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome NCT02037672	Phase 4	Completed	University Medical Centre Ljubljana	36	2013-09 → 2014-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$15.38

per gm

Lowest NADAC/Unit

$15.38

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
80610043060ZORYVE 0.3% FOAM	$15.38	GM	Brand	—	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$680.37

Highest Price

$923.35

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
80610-0430-60ZORYVE 0.3% FOAM,TOP	$923.35	FSS	Arcutis Biotherapeutics, Inc.	01/14/2028
80610-0430-60ZORYVE 0.3% FOAM,TOP	$680.37	Big4	Arcutis Biotherapeutics, Inc.	01/14/2028

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

3 letters from Drugs@FDA

Date	Submission	Document
May 27, 2025	SUPPL -5	View Letter (PDF)
Sep 6, 2024	SUPPL -2	View Letter (PDF)
Dec 19, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.3%

RLD

20 patents2 exclusivities▴

FOAM;TOPICAL | Approved: Dec 15, 2023

Patents (20) · 14 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9884050	Jun 7, 2037	—	—	Yes	—	—
9907788	Jun 7, 2037	—	—	—		—
10940142	Jun 7, 2037	—	—	Yes	—	—
11129818	Aug 25, 2037	—	—	—		—
11707454	Dec 3, 2041	—	—	—		—
11793796	Jun 7, 2037	—	—	Yes	—	—
11819496	Jun 7, 2037	—	—	—		—
11992480	Jun 7, 2037	—	—	—		—
12005051	Jun 7, 2037	—	—	—		—
12005052	Jun 7, 2037	—	—	Yes	—	—
12011437	Jun 7, 2037	—	—	Yes	—	—
12016848	Jun 7, 2037	—	—	Yes	—	—
12042487	Jun 7, 2037	—	—	Yes	—	—
12220409	Jun 7, 2037	—	—	Yes	—	—
12257242	Jun 7, 2037	—	—	Yes	—	—
12310956	Jun 7, 2037	—	—	—		—
12329751	Dec 3, 2041	—	—	—		—
12336983	Jun 7, 2037	—	—	Yes	—	—
12390453	Jun 7, 2037	—	—	Yes	—	—
12453721	Aug 19, 2042	—	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
I-969	May 22, 2028	Active
NP	Dec 15, 2026	< 1 year