Roflumilast - Generic Drug Details

What are the generic sources for roflumilast and what is the scope of freedom to operate?

Roflumilast is the generic ingredient in three branded drugs marketed by Arcutis, Astrazeneca, Alkem Labs Ltd, Anda Repository, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Micro Labs, MSN, Pharmobedient, Prinston Inc, Strides Pharma, Torrent, and Zydus Pharms, and is included in fourteen NDAs. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Roflumilast has fifty-two patent family members in thirteen countries.

There are ten drug master file entries for roflumilast. Sixteen suppliers are listed for this compound.

Summary for roflumilast

International Patents:	52
US Patents:	19
Tradenames:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	111
Patent Applications:	8,028
Drug Prices:	Drug price trends for roflumilast
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for roflumilast
What excipients (inactive ingredients) are in roflumilast?	roflumilast excipients list
DailyMed Link:	roflumilast at DailyMed

See drug prices for roflumilast

Recent Clinical Trials for roflumilast

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Tulane University	PHASE2
Derm Texas, PLLC	PHASE2
The University of Texas Health Science Center at San Antonio	PHASE1

See all roflumilast clinical trials

Pharmacology for roflumilast

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for roflumilast

D05AX	Other antipsoriatics for topical use
D05A	ANTIPSORIATICS FOR TOPICAL USE
D05	ANTIPSORIATICS
D	Dermatologicals

R03DX	Other systemic drugs for obstructive airway diseases
R03D	OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for ROFLUMILAST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZORYVE	Cream	roflumilast	0.3%	215985	1	2023-12-27
DALIRESP	Tablets	roflumilast	250 mcg	022522	1	2019-01-25
DALIRESP	Tablets	roflumilast	500 mcg	022522	7	2015-03-02

US Patents and Regulatory Information for roflumilast

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-002	Jul 9, 2024		RX	Yes	Yes	12,016,848		Y
Zydus Pharms	ROFLUMILAST	roflumilast	TABLET;ORAL	208303-002	Apr 18, 2023	AB	RX	No	No
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-002	Jul 9, 2024		RX	Yes	Yes	12,336,983		Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-002	Jul 9, 2024		RX	Yes	Yes	12,042,487		Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-003	Oct 4, 2025		RX	Yes	Yes	12,016,848		Y

Expired US Patents for roflumilast

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	8,604,064
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	8,618,142
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	8,536,206
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	5,712,298
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	5,712,298

EU/EMA Drug Approvals for roflumilast

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Daxas	roflumilast	EMEA/H/C/001179Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.,	Authorised	no	no	no	2010-07-05
AstraZeneca AB	Libertek	roflumilast	EMEA/H/C/002399Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.	Withdrawn	no	no	no	2011-02-28
AstraZeneca AB	Daliresp	roflumilast	EMEA/H/C/002398Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.	Withdrawn	no	no	no	2011-02-28

International Patents for roflumilast

Country	Patent Number	Title	Estimated Expiration
Canada	3150222	PROCEDE DE REDUCTION D'EFFETS SECONDAIRES PROVENANT DE L'ADMINISTRATION D'INHIBITEURS DE PHOSPHODIESTERASE-4 (METHOD FOR REDUCING SIDE EFFECTS FROM ADMINISTRATION OF PHOSPHODIESTERASE-4 INHIBITORS)
Spain	3033851
Canada	3166300	FORMULATION DE ROFLUMILAST TOPIQUE AYANT UNE ADMINISTRATION ET UNE DEMI-VIE PLASMATIQUE AMELIOREES (TOPICAL ROFLUMILAST FORMULATION HAVING IMPROVED DELIVERY AND PLASMA HALF-LIFE)
New Zealand	759871	Inhibition of crystal growth of roflumilast
Brazil	112022015104

Supplementary Protection Certificates for roflumilast

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1606261	PA2010010,C1606261	Lithuania		PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
1606261	C 2010 014	Romania		PRODUCT NAME: ROFLUMILAST; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/636/001, RO EU/1/10/636/002, RO EU/1/10/636/003; DATE OF NATIONAL AUTHORISATION: 20100705; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/636/001, EMEA EU/1/10/636/002, EMEA EU/1/10/636/003; DATE OF FIRST AUTHORISATION IN EEA: 20100705
1606261	C20100008 00033	Estonia		PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
1606261	PA2010010	Lithuania		PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
0706513	34/2010	Austria		PRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705

Market Dynamics and Financial Trajectory for Roflumilast

Last updated: July 27, 2025

Introduction

Roflumilast (Daliresp, Aformax) is a phosphodiesterase-4 (PDE4) inhibitor primarily indicated for reducing the risk of recurrent exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis. As an oral anti-inflammatory agent, its unique mechanism has positioned it within a niche market amidst potent competitors such as bronchodilators and corticosteroids. This analysis explores the evolving market landscape, key drivers, challenges, and financial outlook for roflumilast over the coming years.

Market Landscape and Key Players

The global COPD treatment market projected to reach USD 17.2 billion by 2026, is marked by intense competition among bronchodilators, corticosteroids, and emerging therapies like biologics [1]. Roflumilast captures a specialized segment targeting exacerbation reduction, particularly for patients with chronic bronchitis phenotype and frequent exacerbations.

Major competitors include:

• Bronchodilators: Long-acting β2-agonists (LABAs), long-acting muscarinic antagonists (LAMAs)
• Anti-inflammatory agents: Inhaled corticosteroids (ICS)
• Novel agents: Biologicals like monoclonal antibodies targeting eosinophilic inflammation

Despite intense competition, roflumilast’s oral route offers convenience over inhaled therapies, providing a distinct value proposition for specific patient subsets.

Market Drivers

Expanding COPD Prevalence

According to the World Health Organization, COPD ranks as the third leading cause of death globally, with an estimated 211 million cases [2]. Aging populations, smoking habits, and rising pollution levels contribute to prevalence growth, directly fueling demand for adjunct therapies like roflumilast.

Guideline Endorsements

Professional societies such as GOLD (Global Initiative for Chronic Obstructive Lung Disease) recommend roflumilast in patients with severe COPD with frequent exacerbations despite optimal inhaled therapy [3], bolstering prescription rates.

Efficacy in Exacerbation Reduction

Roflumilast’s capacity to lower exacerbation frequency translates into reduced hospitalization costs, making it an attractive adjunct treatment in health economics models, especially in healthcare systems prioritizing cost savings.

Patient-Centric Advantages

The oral administration and improvement in quality of life metrics promote adherence, further supporting its market presence.

Market Challenges

Limited Scope of Indication

Roflumilast is indicated mainly for severe COPD with chronic bronchitis phenotype. Its marginal role outside of this subset limits its broad market penetration relative to inhaled therapies.

Side Effect Profile

Common adverse effects include gastrointestinal symptoms, weight loss, and neuropsychiatric events (e.g., depression, anxiety) which hinder tolerability and patient adherence [4].

Pricing and Reimbursement Constraints

High costs relative to inhaled generic therapies restrict access in cost-sensitive markets, especially where reimbursement is limited.

Emerging Therapies

Biologics and gene therapies targeting COPD phenotypes threaten to displace small-molecule therapies in future treatment algorithms.

Financial Trajectory

Revenue Trends

Since its launch in 2013, roflumilast has posted modest but stable growth, driven by increased adoption in US and European markets. The drug's sales reached approximately USD 500 million globally in 2022, with expectations of a compound annual growth rate (CAGR) of around 4-6% over the next five years, fueled by prevalence increases and guideline recommendations [5].

Market Expansion Strategies

Pharmaceutical companies are exploring formulations with improved safety profiles and combination products to enhance utility. For instance, partnerships to combine roflumilast with bronchodilators may boost adherence and expand usage.

Pricing Dynamics

Patent protections until 2025 in key markets ensure pricing power; post-expiry, generic competition may erode revenue. Nonetheless, strategic positioning in niche populations ensures sustained relevance.

Regulatory and Policy Impact

Healthcare system reforms emphasizing cost-effective treatments and decreased reliance on expensive biologics may further favor oral PDE4 inhibitors like roflumilast.

Future Outlook

The introduction of next-generation PDE4 inhibitors with improved safety profiles is anticipated. Additionally, biomarker-driven patient stratification could refine target populations, expanding market share. The trajectory suggests moderate growth driven primarily by the burgeoning COPD burden, with potential fluctuations based on competitive dynamics and healthcare policies.

Conclusion

Roflumilast operates within a complex pharmaceutical ecosystem shaped by unmet needs in severe COPD management, safety considerations, and market competition. Its financial journey remains cautiously optimistic, contingent upon continued epidemiological growth, clinical validation, and strategic positioning to mitigate limitations.

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Key Takeaways

• Roflumilast’s niche positioning for severe COPD with frequent exacerbations sustains steady revenue streams amid competitive inhaled therapies.
• The global COPD epidemic serves as a robust fundamental driver for long-term growth, particularly in aging populations.
• Market challenges such as adverse effects, limited indications, and impending patent expirations require strategic innovation and pipeline development.
• Cost considerations and healthcare policies influence adoption and reimbursement, impacting revenue trajectories.
• Future innovations—combination therapies and personalized medicine—may unlock new growth avenues for roflumilast.

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FAQs

Q1: Will generic versions of roflumilast significantly impact its market share?
Yes. Patent expiries around 2025 in major markets will introduce generics, likely reducing prices and impacting branded sales. However, niche indications and combination therapy developments can sustain revenues.

Q2: How does roflumilast compare with newer COPD treatments?
While newer biologics target eosinophilic phenotypes and may offer better safety profiles, roflumilast’s oral administration and proven efficacy in reduction of exacerbations retain its significance, especially in severe COPD with chronic bronchitis.

Q3: Are there ongoing efforts to address the side effect profile of roflumilast?
Yes. Research focuses on dose optimization, alternative formulations, and combination treatments to improve tolerability.

Q4: How might healthcare policies influence future sales of roflumilast?
Reimbursement restrictions and cost-effectiveness evaluations could limit access in certain regions, while policies promoting chronic disease management could enhance utilization.

Q5: What is the potential for roflumilast in indications beyond COPD?
Currently limited, but ongoing research investigates anti-inflammatory applications in other respiratory and inflammatory conditions. Future approvals depend on clinical trial outcomes.

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References:

1. MarketsandMarkets. COPD treatment market analysis, 2022.
2. WHO. Global prevalence of COPD. 2017.
3. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2023 Report.
4. Kim, S.H., et al. "Safety and tolerability of roflumilast in COPD." Respiratory Medicine, 2020.
5. IQVIA. GlobalPharma Data, 2022.