Roflumilast - Generic Drug Details

What are the generic drug sources for roflumilast and what is the scope of patent protection?

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

Roflumilast has sixty-three patent family members in thirteen countries.

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

Summary for roflumilast

International Patents:	63
US Patents:	20
Tradenames:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	117
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
Beth Israel Deaconess Medical Center	PHASE2
University of California, San Francisco	PHASE4
Ganzhou Hemay Pharmaceutical Co., Ltd	PHASE2

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	215985-001	Jul 29, 2022		RX	Yes	Yes	12,336,983		Y
Arcutis	ZORYVE	roflumilast	FOAM;TOPICAL	217242-001	Dec 15, 2023		RX	Yes	Yes	11,793,796		Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-001	Jul 29, 2022		RX	Yes	Yes	12,005,051
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-003	Oct 4, 2025		RX	Yes	Yes	10,940,142		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	5,712,298
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	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	8,604,064

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
Israel	295172	הרכב רופלומילסט מקומי עם שיפור במתן ובמחצית חיים בפלזמה (Topical roflumilast formulation having improved delivery and plasma half-life)
European Patent Office	4025214
New Zealand	790834
World Intellectual Property Organization (WIPO)	2018226584

Supplementary Protection Certificates for roflumilast

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0706513	SPC/GB10/040	United Kingdom		PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXIDE AND THE SALTS OF THESE COMPOUNDS.; REGISTERED: UK EU/1/10/636/001 20100705; UK EU/1/10/636/002 20100705; UK EU/1/10/636/003 20100705
0706513	10C0052	France		PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXYDE ET LES SELS DE CES COMPOSES; NAT. REGISTRATION NO/DATE: EU/1/16/636/001 20100705; FIRST REGISTRATION: EU/1/10/636/001 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
0706513	1090034-8	Sweden		PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705

ROFLUMILAST: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

Roflumilast is a phosphodiesterase-4 (PDE4) inhibitor used for COPD maintenance in specific patient populations. Commercial momentum is shaped by (1) COPD severity segmentation and guideline positioning, (2) competitive substitution from inhaled bronchodilator and ICS/LABA/LAMA regimens, (3) payer and reimbursement pressure around oral add-on therapies, and (4) the erosion profile typical after patent expiry in multiple geographies. Public financial reporting is limited because roflumilast is not typically broken out as a standalone revenue line by major firms; the financial trajectory below therefore focuses on observable market dynamics, pricing and access forces, and the cost structure that governs profitability at scale.

How does roflumilast fit COPD treatment economics?

Where it sits in care pathways

Roflumilast is used as an oral anti-inflammatory add-on for COPD patients with severe disease and a history of exacerbations, typically alongside optimized inhaled maintenance. It is not positioned as a primary therapy replacing inhaled bronchodilators. This positioning creates a “narrower addressable use case” relative to inhaled classes.

Clinical and labeling bases:

• FDA label: roflumilast is indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. (FDA prescribing information for Daliresp, accessed via Drugs@FDA.) [1]
• EMA product information for roflumilast-containing products also targets chronic obstructive pulmonary disease with chronic bronchitis, severe disease, and exacerbation history. (EMA product information portal.) [2]

Economic implication

Because roflumilast is an add-on oral therapy, demand depends less on broad COPD prevalence and more on:

• The share of patients meeting “severe + chronic bronchitis + exacerbation history”
• Clinician willingness to layer an oral anti-inflammatory onto inhaler regimens
• Payer coverage acceptance for oral add-on drugs versus switching within inhaled classes

What market dynamics drive demand volatility and pricing pressure?

Competition from inhaled regimens

COPD exacerbation reduction is dominated by inhaled long-acting bronchodilators and combination inhalers, with oral therapies competing on marginal benefit. Roflumilast’s demand elasticity is therefore higher during periods of aggressive penetration of inhaled products that shift care away from add-on oral anti-inflammatories.

Key competitive pressure points:

• Inhaled dual and triple therapies (LABA/LAMA and LAMA/LABA/ICS) are often covered broadly because they address dyspnea and exacerbation risk simultaneously.
• Oral therapy face higher persistence friction due to adverse event tolerability (weight loss, GI effects, insomnia/anxiety are label-relevant) which reduces treatment continuation and affects effective demand. (FDA label.) [1]

Tolerability and adherence translate into “net treated patients”

Roflumilast’s market outcome depends on real-world adherence after initiation. Label warnings and adverse event burden impact continuation rates:

• Underweight and weight loss risk is a central differentiator versus many inhaled alternatives. (FDA label.) [1]
• Neuropsychiatric events and insomnia/anxiety are also label-relevant, affecting patient selection and prescriber confidence. (FDA label.) [1]

Market implication: even when coverage exists, effective demand can decelerate if discontinuation reduces “time on drug” and triggers switching.

Payer dynamics after patent expiry

Roflumilast has entered a post-originator competitive phase in many markets. After originator exclusivity ends, pricing typically compresses and volumes shift to lowest net-price offerings. This leads to:

• Margin compression for branded sellers
• Route-to-market consolidation toward generics
• Fragmentation of revenue tracking because multiple manufacturers sell the same dosage forms

Roflumilast’s current market structure is consistent with widely marketed branded availability in the originator era and subsequent generic penetration, aligned with typical PDE4 inhibitor lifecycle economics.

How has the financial trajectory evolved (sales, margins, and profitability drivers)?

Trajectory drivers

Because company financial statements rarely isolate roflumilast line items, financial trajectory is best inferred from structural drivers tied to life-cycle stage:

1. Branded-to-generic transition

   • Revenue growth typically peaks in the branded phase, then declines with generic substitution.
   • Profitability shifts from high-margin originator sales to lower-margin generic or contract manufacturing.

2. Exacerbation-driven usage

   • Uptake rises when patient cohorts that match “severe exacerbator, chronic bronchitis” expand through coding and guideline adherence.
   • Downshift occurs when treatment algorithms emphasize inhaled escalation or when exacerbations are managed with alternative add-ons in specific regions.

3. Label scope and contraindication friction

   • Patient selection is tighter due to adverse event considerations and labeling constraints, limiting addressable use and accelerating churn when tolerability is poor. (FDA label.) [1]

Revenue mechanics that matter most

For a cash-flow model, roflumilast profitability tends to hinge on four variables:

• Net price after rebates and generic competition
• Gross-to-net adjustments driven by payer contracts and wholesaler channel terms
• Treatment duration (adherence and discontinuation) translating into prescription-to-therapy conversion
• Manufacturing scale efficiency because the drug is oral and widely producible once patents expire

Net effect across most small-molecule respiratory brands after exclusivity:

• Volume may hold better than price, but overall revenue and operating income trend down unless market share gains offset price compression.

What are the key regulatory and lifecycle milestones affecting cash flow?

FDA status and dosing/label constraints

Roflumilast’s US regulatory footprint is anchored by Daliresp labeling:

• Indication for reducing risk of COPD exacerbations in severe COPD associated with chronic bronchitis and a history of exacerbations. (FDA.) [1]
• Dosing is weight-driven through titration and discontinuation decisions in tolerability-sensitive patients; label-driven practice affects persistence and thus revenue quality. (FDA label.) [1]

Europe (EMA) product information and authorization scope

EMA product information supports COPD chronic bronchitis exacerbator use. (EMA.) [2]

Lifecycle milestone implication for financial trajectory:

• Broad label reduces total eligible patient pool only marginally (versus severe exacerbator restriction), but it prevents the steep cliff seen when indications are narrowly defined.
• Adverse event profile caps long-term therapy penetration and sustains physician selectivity even after generics reduce price.

Who captures value in roflumilast’s supply chain?

Originator branded seller vs generic manufacturers

Value capture shifts over time:

• Originator: higher unit margins earlier; revenue peaks during branded adoption in severe exacerbator cohorts.
• Generic phase: volume and market share matter more than price, and the dominant profits accrue to producers with scale, procurement advantages, and stable contracted distribution.

Specialty channel role

In many respiratory markets, COPD care routes through pneumology and general internal medicine. That structure limits impulse buying and reinforces guideline-aligned prescribing.

Result: switching occurs at renewal and regimen optimization points, so price pressure from generics can be slower to translate into fully absorbed market share but eventually dominates once substitution becomes routine.

How does roflumilast perform versus other COPD add-ons in investment terms?

Relative risk profile

Roflumilast’s investment thesis typically screens through these risk lenses:

• Clinical differentiation risk: PDE4 is mechanistically distinct, but inhaled regimens plus other oral options can compete for “exacerbation add-on” budgets.
• Commercial differentiation risk: oral add-on drugs can lose share if payer formularies narrow access.
• Life-cycle risk: post-patent pricing compression is the central commercial risk.

Cash-flow profile

Compared with first-in-class assets, roflumilast’s cash-flow profile is usually:

• Mature demand with periodic drops after formulary changes
• Low upside torque unless a regional payer broadens access or patient selection expands

What are the practical signals investors track for roflumilast performance?

1) Exacerbation cohort growth vs guideline drift

Investors monitor:

• Rates of severe COPD exacerbations treated in outpatient settings
• Guideline shifts that alter the preferred sequence of inhaled escalation vs oral anti-inflammatory add-ons

These influence the “severe chronic bronchitis exacerbator” population treated.

2) Net price and rebate trajectory in major markets

Even without public roflumilast-only segment reporting, financial trajectory tracks:

• Originator discounting and rebate intensity in the branded stage
• Generic erosion rate after substitution

3) Persistence and discontinuation due to tolerability

Label-driven tolerability is a leading indicator:

• Weight loss and GI side effects correlate with higher discontinuation in routine practice.
• Any changes in clinical education or patient management protocols affect time-on-therapy and thus revenue quality. (FDA label.) [1]

Key Takeaways

• Roflumilast demand is concentrated in severe COPD chronic bronchitis patients with exacerbation history, making it a targeted add-on rather than a volume-wide COPD baseline therapy. (FDA label.) [1]
• Market dynamics are dominated by substitution from inhaled regimens, tolerability-driven persistence limits, and payer/formulary pressure after exclusivity.
• The financial trajectory most often follows a classic small-molecule pattern: branded peak followed by generic-driven net price compression, with revenue stabilization only if treatment duration and patient selection remain strong.
• Profitability depends less on top-line growth and more on net price, gross-to-net control, and adherence-driven treatment duration.

FAQs

1) Is roflumilast a first-line COPD therapy?

No. It is indicated as an add-on to reduce COPD exacerbation risk in severe COPD associated with chronic bronchitis and a history of exacerbations. (FDA.) [1]

2) What drives prescription volume for roflumilast?

The size of the treated severe exacerbator cohort plus persistence after initiation, which is constrained by tolerability considerations in routine use. (FDA label.) [1]

3) How does generic competition affect roflumilast’s financial performance?

It compresses net prices and reallocates market share to lowest net-cost suppliers, typically lowering operating margins for branded manufacturers post-exclusivity.

4) What label issues most affect adherence and thus revenue quality?

Weight loss/underweight risk and neuropsychiatric or sleep-related adverse effects influence patient selection and continuation. (FDA label.) [1]

5) What is the most relevant regulatory anchor for US commercial planning?

FDA labeling for Daliresp defines indication and constraints that drive eligible patient identification and prescribing behavior. (FDA.) [1]

References

[1] U.S. Food and Drug Administration. (n.d.). Daliresp (roflumilast) prescribing information. Drugs@FDA.
[2] European Medicines Agency. (n.d.). Product information for roflumilast-containing medicines. EMA.