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Last Updated: October 4, 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

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

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.

Patents protecting DALIRESP

Process for the preparation of roflumilast
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS

Process for the preparation of roflumilast
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS

Process for the preparation of roflumilast
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 ⤷  Sign Up ⤷  Sign Up
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 ⤷  Sign Up ⤷  Sign Up
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 ⤷  Sign Up ⤷  Sign Up
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 ⤷  Sign Up ⤷  Sign Up
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 ⤷  Sign Up ⤷  Sign Up
>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
Australia 7490794 ⤷  Sign Up
Iceland 7410 ⤷  Sign Up
Japan H08512041 ⤷  Sign Up
Eurasian Patent Organization 200501350 НОВЫЙ СПОСОБ ПОЛУЧЕНИЯ РОФЛУМИЛАСТА ⤷  Sign Up
Slovakia 161795 FLUOROALKOXY-SUBSTITUTED BENZAMIDES, MANUFACTURING PROCESS AND THEIR USE AS CYCLIC NUCLEOTIDE PHOSPHODIESTERASE INHIBITORS ⤷  Sign Up
South Korea 20040084926 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DALIRESP

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0706513 CA 2010 00028 Denmark ⤷  Sign Up
0706513 C300462 Netherlands ⤷  Sign Up 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
0706513 34/2010 Austria ⤷  Sign Up PRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705
0706513 SPC/GB10/040 United Kingdom ⤷  Sign Up 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 C00706513/01 Switzerland ⤷  Sign Up FORMER OWNER: NYCOMED GERMANY HOLDING GMBH, DE
1606261 C 2010 014 Romania ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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