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Last Updated: March 29, 2024

ROFLUMILAST - Generic Drug Details


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What are the generic sources for roflumilast and what is the scope of freedom to operate?

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

Roflumilast has seventy-eight patent family members in twenty-nine countries.

There are ten drug master file entries for roflumilast. Thirteen suppliers are listed for this compound.

Drug Prices for ROFLUMILAST

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Recent Clinical Trials for ROFLUMILAST

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

SponsorPhase
Mansoura UniversityPhase 1/Phase 2
Jacob Pontoppidan ThyssenPhase 4
The Novo Nordic FoundationPhase 4

See all ROFLUMILAST clinical trials

Pharmacology for ROFLUMILAST
Paragraph IV (Patent) Challenges for ROFLUMILAST
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZORYVE Cream roflumilast 0.3% 215985 1 2023-12-27
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
Arcutis ZORYVE roflumilast FOAM;TOPICAL 217242-001 Dec 15, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Micro Labs ROFLUMILAST roflumilast TABLET;ORAL 208180-001 Mar 22, 2019 AB RX No 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 ⤷  Try a Trial
Aurobindo Pharma Ltd ROFLUMILAST roflumilast TABLET;ORAL 213298-001 Apr 17, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Arcutis ZORYVE roflumilast FOAM;TOPICAL 217242-001 Dec 15, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Torrent ROFLUMILAST roflumilast TABLET;ORAL 208272-001 Aug 6, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 ROFLUMILAST

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
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 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
Eurasian Patent Organization 039942 ИНГИБИРОВАНИЕ РОСТА КРИСТАЛЛА РОФЛУМИЛАСТА (INHIBITION OF GROWTH OF ROFLUMILAST CRYSTAL) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2018226584 ⤷  Try a Trial
Croatia P20050399 NOVEL PROCESS FOR THE PREPARATION OF ROFLUMILAST ⤷  Try a Trial
South Korea 20200016940 로플루밀라스트의 결정 성장의 저해 ⤷  Try a Trial
China 116963717 具有抗真菌性能的局部用罗氟司特制剂 (Topical roflumilast formulations with antifungal properties) ⤷  Try a Trial
Japan 4742026 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ROFLUMILAST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1606261 C 2010 014 Romania ⤷  Try a Trial 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 ⤷  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
1606261 PA2010010,C1606261 Lithuania ⤷  Try a Trial PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
1606261 PA2010010 Lithuania ⤷  Try a Trial PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
0706513 1090034-8 Sweden ⤷  Try a Trial PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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