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Last Updated: November 29, 2022

Roflumilast - Generic Drug Details


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What are the generic drug sources for roflumilast and what is the scope of patent protection?

Roflumilast is the generic ingredient in three branded drugs marketed by Arcutis, Astrazeneca, Breckenridge, Hetero Labs Ltd Iii, Micro Labs, MSN, Mylan, Prinston Inc, Strides Pharma, Torrent, and Zydus Pharms, and is included in eleven NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Roflumilast has one hundred and eleven patent family members in thirty-six countries.

There are ten drug master file entries for roflumilast. Nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for roflumilast
Recent Clinical Trials for roflumilast

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

SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Early Phase 1
Children's Hospital Medical Center, CincinnatiEarly Phase 1
Dermatology Consulting Services, PLLCPhase 2

See all roflumilast clinical trials

Generic filers with tentative approvals for ROFLUMILAST
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing500MCGTABLET;ORAL
See Plans and PricingSee Plans and Pricing500MCGTABLET;ORAL
See Plans and PricingSee Plans and Pricing250MCGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for roflumilast
Paragraph IV (Patent) Challenges for ROFLUMILAST
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 roflumilast

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Breckenridge ROFLUMILAST roflumilast TABLET;ORAL 208236-001 Oct 3, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msn ROFLUMILAST roflumilast TABLET;ORAL 208256-001 Sep 7, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-001 Jul 29, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Zydus Pharms ROFLUMILAST roflumilast TABLET;ORAL 208303-001 Feb 10, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan ROFLUMILAST roflumilast TABLET;ORAL 208257-001 Jul 13, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

International Patents for roflumilast

Country Patent Number Title Estimated Expiration
Ukraine 84266 ДОЗИРОВАННАЯ ВРАЧЕБНАЯ ФОРМА В ВИДЕ ТАБЛЕТКИ ИЛИ ГРАНУЛЫ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ, КОТОРАЯ СОДЕРЖИТ ИНГИБИТОР PDE 4 И ПОЛИВИНИЛПИРОЛИДОН, СПОСОБЫ ЕЕ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ;ДОЗОВАНА ЛІКАРСЬКА ФОРМА У ВИГЛЯДІ ТАБЛЕТКИ АБО ПЕЛЕТИ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕННЯ, ЯКА МІСТИТЬ ІНГІБІТОР PDE 4 ТА ПОЛІВІНІЛПІРОЛІДОН, СПОСОБИ ЇЇ ОДЕРЖАННЯ ТА ЗАСТОСУВАННЯ (ORAL DOSAGE FORM CONTAINING A PDE 4 INHIBITOR AS AN ACTIVE INGREDIENT AND POLYVINYLPYROOLIDON AS EXCIPIENT, PROCESSES FOR THE PREPARATION AND USE THEREOF) See Plans and Pricing
South Korea 20050106392 NOVEL PROCESS FOR THE PREPARATION OF ROFLUMILAST See Plans and Pricing
Slovenia 2258394 See Plans and Pricing
South Africa 200503191 Novel process for the preparation of roflumilast. See Plans and Pricing
Peru 20030823 FORMA DE DOSIFICACION QUE CONTIENE UN INHIBIDOR DE LA PDE 4 COMO INGREDIENTE ACTIVO See Plans and Pricing
Japan 4163120 See Plans and Pricing
Eurasian Patent Organization 008219 ДОЗИРОВАННАЯ ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ ПЕРОРАЛЬНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩАЯ ИНГИБИТОР PDE 4 В КАЧЕСТВЕ ДЕЙСТВУЮЩЕГО ВЕЩЕСТВА И ПОЛИВИНИЛПИРРОЛИДОН В КАЧЕСТВЕ ВСПОМОГАТЕЛЬНОГО ВЕЩЕСТВА (ORAL DOSAGE FORM CONTAINING A PDE 4 INHIBITOR AS AN ACTIVE INGREDIENT AND POLYVINYLPYRROLIDON AS EXCIPIENT) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for roflumilast

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0706513 C300462 Netherlands See Plans and Pricing 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 C 2010 014 Romania See Plans and Pricing 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 See Plans and Pricing 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
1606261 C20100008 00033 Estonia See Plans and Pricing PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
0706513 1090034-8 Sweden See Plans and Pricing PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705
0706513 34/2010 Austria See Plans and Pricing PRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705
1606261 PA2010010 Lithuania See Plans and Pricing PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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