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Last Updated: December 22, 2024

DALIRESP Drug Patent Profile


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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. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-seven patent family members in twenty-nine countries.

The generic ingredient in DALIRESP is roflumilast. There are ten drug master file entries for this compound. Fourteen 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 MYLAN on July 13th, 2018.

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Drug patent expirations by year for DALIRESP
Drug Prices for DALIRESP

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Recent Clinical Trials for DALIRESP

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SponsorPhase
Chiesi Farmaceutici S.p.A.Phase 3
Johns Hopkins UniversityPhase 3
Patient-Centered Outcomes Research InstitutePhase 3

See all DALIRESP clinical trials

Pharmacology for DALIRESP
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

DALIRESP is protected by three US patents.

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

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 ⤷  Subscribe ⤷  Subscribe
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 ⤷  Subscribe ⤷  Subscribe
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for DALIRESP

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

Country Patent Number Title Estimated Expiration
Iceland 2723 ⤷  Subscribe
Serbia 20050669 NOVI POSTUPAK ZA DOBIJANJE ROFLUMILASTA (NOVEL PROCESS FOR THE PREPARATION OF ROFLUMILAST) ⤷  Subscribe
Argentina 043531 PROCEDIMIENTO PARA LA PREPARACION DE N-(3, 5-DICLOROPIDID-4-IL)-3-CICLOPROPILMETOXI-4-DIFLUOROMETOXIBENZAMIDA (INN: ROFLUMILAST) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DALIRESP

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0706513 SPC031/2010 Ireland ⤷  Subscribe SPC031/2010: 20110906, EXPIRES: 20190701
1606261 C 2010 014 Romania ⤷  Subscribe 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 10C0052 France ⤷  Subscribe 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

DALIRESP Market Analysis and Financial Projection Experimental

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]

More… ↓

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