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Last Updated: March 28, 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. Thirteen 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
>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
Slovenia 2258394 ⤷  Try a Trial
Norway 955211 ⤷  Try a Trial
Mexico PA04005759 FORMA DE DOSIS ORAL QUE CONTIENE UN INHIBIDOR DE PDE 4 COMO UN INGREDIENTE ACTIVO Y POLIVINILPIRROLIDONA COMO EXCIPIENTE. (ORAL DOSAGE FORM CONTAINING A PDE 4 INHIBITOR AS AN ACTIVE INGREDIENT AND POLYVINYLPYRROLIDON AS EXCIPIENT.) ⤷  Try a Trial
Latvia 13074 FLUOROALKOXY-SUBSTITUTED BENZAMIDES AND THEIR USE AS CYCLIC NUCLEOTIDE PHOSPHODIESTERASE INHIBITORS ⤷  Try a Trial
Slovenia 1478399 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for Daliresp

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0706513 SPC/GB10/040 United Kingdom ⤷  Try a Trial 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 CA 2010 00028 Denmark ⤷  Try a Trial
0706513 C300462 Netherlands ⤷  Try a Trial 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 10C0052 France ⤷  Try a Trial 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 C00706513/01 Switzerland ⤷  Try a Trial FORMER OWNER: NYCOMED GERMANY HOLDING GMBH, DE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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