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, 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 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:	60
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	215985-003	Oct 4, 2025		RX	Yes	Yes			Y
Torrent	ROFLUMILAST	roflumilast	TABLET;ORAL	208272-001	Aug 6, 2018		DISCN	No	No
Arcutis	ZORYVE	roflumilast	FOAM;TOPICAL	217242-001	Dec 15, 2023		RX	Yes	Yes

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
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011

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
Mexico	2022013151
Japan	2023513092	向上した送達および血漿半減期を有する局所用ロフルミラスト配合物
Mexico	2022013151	INHIBICION DEL CRECIMIENTO DE CRISTALES DE ROFLUMILAST. (INHIBITION OF CRYSTAL GROWTH OF ROFLUMILAST.)

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
0706513	C300462	Netherlands		PRODUCT NAME: ROFLUMILAST, DESGEWENST IN DE VORM VAN HET N-OXIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; 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

Roflumilast: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is the current market size and growth outlook for roflumilast?

Roflumilast (sold as Daliresp in the U.S., and Daxas elsewhere) is a selective phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of chronic obstructive pulmonary disease (COPD). The drug's sales generate significant revenue within respiratory therapeutics, driven by the increasing prevalence of COPD worldwide.

In 2022, the global COPD drug market was valued at approximately $13 billion, with roflumilast accounting for an estimated $200 million in sales. The compound's market share remains modest relative to inhaled bronchodilators but is growing steadily.

Forecasts predict a compound annual growth rate (CAGR) of 7% for the COPD therapeutics segment through 2027, largely fueled by aging populations and increased diagnosis rates. Roflumilast's uptake is expected to benefit from this overall industry trend, with projected sales reaching $350 million by 2027.

How does Roflumilast compare to competitors in the COPD treatment space?

Roflumilast competes with a broad class of inhaled therapies, including:

• Long-Acting Beta-Agonists (LABA)
• Long-Acting Muscarinic Antagonists (LAMA)
• Inhaled corticosteroids (ICS)

These inhaled therapies commonly dominate COPD management, accounting for over 80% of the market. Roflumilast's focus is on reducing exacerbations, often used as an add-on therapy for severe COPD with chronic bronchitis.

In terms of sales, inhaled bronchodilators corner approximately 80% of the market, whereas roflumilast holds less than 2% as of 2022. The drug’s niche positioning limits its initial market penetration but allows growth through combined therapy strategies.

What regulatory and patent challenges influence roflumilast's market trajectory?

• Patent Expiry: The original patent for roflumilast has expired in many jurisdictions, including the U.S. as of 2022. This HAS prompted development of generic versions, threatening revenue streams.
• Regulatory Approvals: The drug holds FDA approval for COPD but has faced delays in obtaining approval for other indications like asthma.
• Side Effect Profile: Roflumilast's adverse effect profile includes gastrointestinal symptoms and neuropsychiatric effects. These issues restrict its use to specific patient groups.

What are the key clinical and market trends affecting future revenues?

Clinical trends favor combination therapies, integrating roflumilast with inhaled agents to improve efficacy. The pursuit of biomarkers aims to identify patient segments most likely to benefit, potentially expanding roflumilast’s market share.

Market trends include increased use in emerging markets, where COPD prevalence is rapidly rising, particularly in Asia-Pacific, driven by air pollution and smoking rates.

How are pricing and reimbursement strategies shaping revenue outlooks?

Pricing varies across markets, with the U.S. list price around USD 3000 per year per patient. Payers often restrict reimbursement to severe COPD cases. Cost-effectiveness analyses influence formulary decisions, and ongoing negotiations could impact sales volume.

In emerging economies, pricing strategies are adjusted for affordability, limiting revenue but expanding access.

What is the potential pipeline for roflumilast and similar PDE4 inhibitors?

Early-stage research aims to develop next-generation PDE4 inhibitors with improved efficacy and fewer side effects. Agents with oral bioavailability and targeted delivery are under investigation to broaden indications to conditions like asthma and idiopathic pulmonary fibrosis.

Summary of financial implications

Factor	Impact
Patent expiry	Negative; generic competition expected to reduce revenue by up to 70% within five years
Market growth	Positive; COPD market expanding at 7% CAGR through 2027
Use in combination therapy	Positive; could increase patient adherence and extend indications
Emerging markets	Positive; rapid COPD prevalence growth offers new revenue streams
Cost and reimbursement	Variable; influences pricing strategies and patient access

Key Takeaways

• Roflumilast's global sales stood at approximately $200 million in 2022, with projections reaching $350 million by 2027.
• The poster child for PDE4 inhibitors in COPD faces generic competition following patent expiration.
• The therapy's niche positioning limits its share but provides growth opportunities through combination use and emerging markets.
• Regulatory and clinical developments are critical in shaping future revenue streams.
• Pricing, reimbursement, and healthcare policy decisions will significantly influence financial performance.

FAQs

1. What are the primary factors limiting roflumilast sales?
   Patent expiration, side effect profile, and competition from inhaled therapies limit sales.

2. How does roflumilast's market share compare with inhaled COPD medications?
   It has less than 2% market share compared to inhaled drugs, which dominate with over 80%.

3. Are there regulatory pathways to expand roflumilast’s indications?
   Yes, ongoing clinical trials for other respiratory conditions could open new markets.

4. What is the primary driver of growth for roflumilast?
   Increased COPD prevalence in emerging markets and use in combination therapies.

5. How are generic versions affecting the market?
   Generic competition is expected to erode revenue significantly following patent expiry.

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References

[1] MarketWatch. (2023). COPD drugs market size, share & trends analysis.
[2] IQVIA. (2022). Global drug sales report 2022.
[3] U.S. Food and Drug Administration. (2022). Roflumilast approval and patent status.
[4] Research and Markets. (2023). COPD therapeutics pipeline analysis.
[5] Pharma Intelligence. (2022). Respiratory drugs market forecast.