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, Breckenridge, Hetero Labs Ltd Iii, Micro Labs, MSN, Mylan, Prinston Inc, Strides Pharma, Torrent, and Zydus Pharms, and is included in fourteen NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Roflumilast has eighty-five patent family members in twenty-nine countries.

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

Summary for ROFLUMILAST

International Patents:	85
US Patents:	16
Tradenames:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	99
Patent Applications:	7,299
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
Mansoura University	Phase 1/Phase 2
Jacob Pontoppidan Thyssen	Phase 4
The Novo Nordic Foundation	Phase 4

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	9,907,788
Torrent	ROFLUMILAST	roflumilast	TABLET;ORAL	208272-002	Oct 18, 2024	AB	RX	No	No
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-001	Jul 29, 2022		RX	Yes	Yes	11,129,818
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-002	Jul 9, 2024		RX	Yes	Yes	11,129,818
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-001	Jul 29, 2022		RX	Yes	Yes	10,940,142		Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-002	Jul 9, 2024		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	9,468,598
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	022522-002	Jan 23, 2018	5,712,298
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	5,712,298
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	8,431,154

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/001179 Daxas 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/002399 Libertek 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/002398 Daliresp 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
Austria	447555
Canada	2503290	NOUVEAU PROCEDE DE PREPARATION DE ROFLUMILAST (NOVEL PROCESS FOR THE PREPARATION OF ROFLUMILAST)
European Patent Office	4255393	FORMULATION TOPIQUE DE ROFLUMILAST PRÉSENTANT DES PROPRIÉTÉS ANTIFONGIQUES (TOPICAL ROFLUMILAST FORMULATION HAVING ANTIFUNGAL PROPERTIES)
China	112263577	罗氟司特晶体生长的抑制 (Inhibition of roflumilast crystal growth)
Australia	2021214399	Topical roflumilast formulation having improved delivery and plasma half-life
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
0706513	1090034-8	Sweden		PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: 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	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	C20100008 00033	Estonia		PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
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
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

ROFLUMILAST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Roflumilast

Introduction to Roflumilast

Roflumilast, a phosphodiesterase-4 (PDE4) inhibitor, has been making significant waves in the pharmaceutical industry, particularly in the treatment of dermatological conditions and chronic obstructive pulmonary disease (COPD). Here, we delve into the market dynamics and financial trajectory of this drug, focusing on its recent approvals, market performance, and future projections.

FDA Approvals and Market Expansion

Roflumilast, under the brand name ZORYVE, has recently received several FDA approvals that have significantly expanded its market reach. The FDA approved ZORYVE cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in patients aged six and older, marking a crucial milestone for Arcutis Biotherapeutics[3].

• Atopic Dermatitis Treatment: ZORYVE cream 0.15% is the first steroid-free treatment for AD, addressing the long-term use risks associated with topical steroids. This unique selling proposition is expected to attract patients and caregivers seeking safer alternatives[3].

• Scalp and Body Psoriasis: The FDA has also accepted a supplemental New Drug Application (sNDA) for ZORYVE foam for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over, with a PDUFA action date of May 22, 2025[2].

Financial Performance

Arcutis Biotherapeutics has seen a substantial surge in revenue driven by the success of ZORYVE products.

• Third Quarter 2024 Financial Results: Product revenues for the quarter ended September 30, 2024, were $44.8 million, a significant increase from $8.1 million in the corresponding period in 2023. This growth was driven by strong unit demand and improvements in gross-to-net (GTN) rates, which are now in the low 50% range[2][5].

• Revenue Breakdown: The revenue was distributed as follows: $22.0 million for ZORYVE cream 0.3%, $20.3 million for ZORYVE topical foam 0.3%, and $2.5 million for ZORYVE cream 0.15%. This indicates robust sales across all formulations of the drug[2][5].

Market Dynamics

The market for atopic dermatitis and other dermatological conditions is highly competitive, but ZORYVE's unique characteristics are positioning it favorably.

• Competitive Advantage: ZORYVE's steroid-free formulation is a key differentiator, allowing it to capture market share from traditional topical steroid treatments. This is particularly important given the long-term use risks associated with steroids[3].

• Patient and Caregiver Preference: The non-steroidal nature of ZORYVE is likely to attract a substantial number of patients and caregivers seeking safer and more effective treatments. Clinical trials have shown significant improvements, with 69% of patients experiencing at least a 50% reduction in symptoms within four weeks[3].

Commercial Strategy

Arcutis has implemented a strategic approach to ensure the wide availability and adoption of ZORYVE.

• Distribution and Access: The company is ensuring wide availability through key pharmacy channels and patient support programs like the ZORYVE Direct Program. This strategy facilitates access and addresses potential cost barriers, enhancing patient adherence and satisfaction[3].

• Prescription Growth: There has been sustained growth in prescriptions for both ZORYVE cream and foam, with a total U.S. franchise unit demand increase of 25% quarter over quarter. This indicates strong market acceptance and growing demand[2].

Future Projections

The global roflumilast market is expected to continue its upward trajectory.

• Market Growth: The global roflumilast market is projected to grow from $1.523 billion in 2024 to $2.526 billion by 2030, at a compound annual growth rate (CAGR) that reflects the increasing adoption of roflumilast-based treatments[4].

• Expanding Indications: With the potential approval for scalp and body psoriasis and other dermatological conditions, the market for roflumilast is expected to expand further, contributing to its financial growth[2].

Financial Trajectory

Arcutis Biotherapeutics' financial performance is closely tied to the success of ZORYVE.

• Revenue Growth: The company has experienced 45% revenue growth this quarter, marking sequential quarter growth since January 2023. This trend is expected to continue as more patients and healthcare providers adopt ZORYVE[2][5].

• Operating Expenses: While the company has seen an increase in selling, general, and administrative (SG&A) expenses due to sales and marketing efforts, the decrease in research and development (R&D) expenses related to the topical roflumilast program has helped in managing overall costs[2][5].

• Cash Position: As of September 30, 2024, Arcutis had $331.2 million in cash, cash equivalents, restricted cash, and marketable securities, providing a solid financial foundation for future operations and growth initiatives[2].

Key Takeaways

• FDA Approvals: ZORYVE has received multiple FDA approvals, expanding its use in treating atopic dermatitis and other dermatological conditions.
• Financial Growth: Arcutis has seen significant revenue growth driven by strong demand for ZORYVE products.
• Market Dynamics: ZORYVE's steroid-free formulation is a key differentiator, capturing market share from traditional treatments.
• Commercial Strategy: Wide availability and patient support programs are enhancing adoption and patient satisfaction.
• Future Projections: The global roflumilast market is expected to grow substantially, driven by expanding indications and increasing adoption.

FAQs

Q: What is roflumilast, and how is it used? A: Roflumilast is a phosphodiesterase-4 (PDE4) inhibitor used in the treatment of atopic dermatitis, scalp and body psoriasis, and other dermatological conditions under the brand name ZORYVE.

Q: What are the key FDA approvals for ZORYVE? A: ZORYVE has been approved for treating mild to moderate atopic dermatitis in patients aged six and older, and an sNDA has been accepted for the treatment of scalp and body psoriasis.

Q: How has Arcutis Biotherapeutics' revenue been impacted by ZORYVE? A: Arcutis has seen a significant increase in revenue, with $44.8 million in product revenues for the third quarter of 2024, driven by strong demand for ZORYVE products.

Q: What is the competitive advantage of ZORYVE? A: ZORYVE's steroid-free formulation is a key differentiator, addressing the long-term use risks associated with traditional topical steroids.

Q: What are the future projections for the global roflumilast market? A: The global roflumilast market is projected to grow from $1.523 billion in 2024 to $2.526 billion by 2030, driven by expanding indications and increasing adoption.

Sources

1. Global Roflumilast Market Size, Scope And Forecast Report - Market Research Intellect
2. Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update - GlobeNewswire
3. FDA Approves Arcutis' ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis - StockTitan
4. Global Roflumilast Market Insights, Forecast to 2030 - QYResearch
5. Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update - Arcutis Biotherapeutics