DALIRESP Drug Patent Profile

When do Daliresp patents expire, and when can generic versions of Daliresp launch?

Daliresp is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in DALIRESP is roflumilast. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Daliresp

A generic version of DALIRESP was approved as roflumilast by NORVIUM BIOSCIENCE on July 13^th, 2018.

Summary for DALIRESP

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	17
Patent Applications:	5,558
Drug Prices:	Drug price information for DALIRESP
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DALIRESP
What excipients (inactive ingredients) are in DALIRESP?	DALIRESP excipients list
DailyMed Link:	DALIRESP at DailyMed

See drug prices for DALIRESP

Recent Clinical Trials for DALIRESP

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

Sponsor	Phase
Chiesi Farmaceutici S.p.A.	Phase 3
Johns Hopkins University	Phase 3
Patient-Centered Outcomes Research Institute	Phase 3

See all DALIRESP clinical trials

Pharmacology for DALIRESP

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Paragraph IV (Patent) Challenges for DALIRESP

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 DALIRESP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	AB	RX	Yes	Yes
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	AB	RX	Yes	No

Expired US Patents for DALIRESP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	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	8,431,154
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	9,468,598
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	8,604,064

EU/EMA Drug Approvals for DALIRESP

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	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
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

International Patents for DALIRESP

See the table below for patents covering DALIRESP around the world.

Country	Patent Number	Title	Estimated Expiration
China	1046939
Ecuador	SP045238	FORMA DE DOSIS ORAL QUE CONTIENE UN INHIBIDOR DE PDE 4 COMO UN INGREDIENTE ACTIVO Y POLIVINILPIRROLIDONA COMO EXCIPIENTE
New Zealand	271316	FLUOROALKOXY BENZAMIDE DERIVATIVES, PHARMACEUTICAL COMPOSITIONS
Norway	955211
Slovakia	283263
World Intellectual Property Organization (WIPO)	03070279

Supplementary Protection Certificates for DALIRESP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	PA2010010,C1606261	Lithuania		PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 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

Market Dynamics and Financial Trajectory for DALIRESP

Introduction

DALIRESP (roflumilast) is a phosphodiesterase-4 (PDE4) inhibitor used primarily for the treatment of chronic obstructive pulmonary disease (COPD) and other respiratory conditions. To understand the market dynamics and financial trajectory of DALIRESP, it is crucial to analyze various factors including its clinical performance, market competition, regulatory environment, and financial data.

Clinical Performance and Safety Profile

DALIRESP has been shown to improve lung function and reduce exacerbations in patients with COPD. However, its use is associated with several adverse reactions, including psychiatric events such as insomnia, anxiety, and depression, as well as weight loss and suicidal ideation[4].

Adverse Reactions and Monitoring

The psychiatric adverse reactions, particularly the risk of suicidal ideation and behavior, necessitate careful monitoring and patient counseling. This complex safety profile can impact patient adherence and prescriber confidence, potentially influencing market dynamics.

Market Competition

The COPD treatment market is highly competitive, with various therapies available, including bronchodilators, combination inhalers, and other PDE4 inhibitors.

Competitive Landscape

DALIRESP competes with other COPD treatments such as combination therapies like Breo Ellipta and Anoro Ellipta, as well as other PDE4 inhibitors. The competitive landscape is dynamic, with new treatments and formulations being approved, which can affect the market share of DALIRESP.

Regulatory Environment

Regulatory approvals and labeling changes can significantly impact the market dynamics of any drug.

FDA Labeling and Warnings

The FDA labeling for DALIRESP includes warnings about psychiatric adverse reactions and the need for careful patient monitoring. Any changes to these warnings or additional regulatory actions can influence prescribing patterns and patient safety, thereby affecting the drug's financial trajectory.

Financial Performance

To assess the financial trajectory of DALIRESP, we need to look at the broader financial context of its manufacturer and the specific revenue data related to the drug.

Revenue Trends

While specific revenue figures for DALIRESP are not provided in the sources, we can infer from the broader pharmaceutical market trends. For instance, AstraZeneca's financial reports highlight significant revenue growth in other therapeutic areas but do not specifically detail DALIRESP's performance. However, given the competitive nature of the COPD market and the drug's safety profile, it is likely that DALIRESP's revenue may not be as robust as other therapies.

Impact of Safety Profile on Sales

The safety profile of DALIRESP, particularly the psychiatric adverse reactions, can deter some prescribers and patients, potentially limiting its market penetration.

Patient Adherence and Prescriber Confidence

The need for regular monitoring and the risk of severe adverse reactions can reduce patient adherence and prescriber confidence. This can lead to lower sales and a less favorable financial trajectory compared to competitors with more favorable safety profiles.

Market Penetration and Geographic Performance

The performance of DALIRESP can vary geographically based on local healthcare systems, reimbursement policies, and patient demographics.

Geographic Variations

In regions with stringent regulatory environments or where patient safety is a paramount concern, DALIRESP may face additional hurdles. For example, in the EU, stricter safety monitoring might be required, which could impact sales.

Comparison with Other Therapies

Comparing DALIRESP with other COPD treatments can provide insights into its market position.

Efficacy and Safety Comparison

While DALIRESP has shown efficacy in improving lung function and reducing exacerbations, its safety profile is a significant concern. Other treatments, such as combination inhalers, may offer better safety profiles and thus attract more prescribers and patients.

Future Outlook

The future outlook for DALIRESP depends on several factors, including ongoing clinical trials, regulatory updates, and market competition.

Potential for New Indications

If DALIRESP were to be approved for additional indications or if new formulations were developed that mitigate its safety concerns, it could potentially regain market share. However, this would require significant investment in research and development.

Competitive Innovations

The COPD treatment landscape is evolving with new therapies and technologies. Innovations such as biologics or more targeted therapies could further erode DALIRESP's market share unless it adapts to these changes.

Key Takeaways

• Clinical Performance: DALIRESP is effective in treating COPD but has a complex safety profile.
• Market Competition: The COPD market is highly competitive, with DALIRESP facing challenges from other therapies.
• Regulatory Environment: FDA warnings and labeling changes can impact prescribing patterns.
• Financial Performance: Specific revenue data is not available, but the drug's safety profile likely affects its sales.
• Geographic Performance: Sales can vary geographically due to local healthcare policies and patient demographics.
• Future Outlook: The drug's future depends on addressing safety concerns and adapting to market innovations.

FAQs

What is DALIRESP used for?

DALIRESP (roflumilast) is used primarily for the treatment of chronic obstructive pulmonary disease (COPD).

What are the common adverse reactions associated with DALIRESP?

Common adverse reactions include psychiatric events such as insomnia, anxiety, and depression, as well as weight loss and suicidal ideation[4].

How does DALIRESP compare to other COPD treatments in terms of safety?

DALIRESP has a more complex safety profile compared to many other COPD treatments, particularly due to its psychiatric adverse reactions.

What impact does the regulatory environment have on DALIRESP?

The FDA labeling and warnings about psychiatric adverse reactions can influence prescribing patterns and patient safety, affecting the drug's market dynamics.

What is the future outlook for DALIRESP in the COPD treatment market?

The future outlook depends on addressing safety concerns, potential new indications, and adapting to market innovations and competitive pressures.

Sources

1. DALIRESP (roflumilast) tablets - FDA Label[4]
2. AstraZeneca Full-year and Q4 2023 results announcement - AstraZeneca[1]
3. AstraZeneca Q1-2023-results-announcement - AstraZeneca[3]
4. Arcutis Announces Fourth Quarter and Full Year 2021 Financial Results - Arcutis[2]