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Last Updated: December 13, 2024

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, 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 sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Roflumilast has eighty-five patent family members in twenty-nine countries.

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

Drug Prices for roflumilast

See drug prices for roflumilast

Recent Clinical Trials for roflumilast

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

SponsorPhase
Mansoura UniversityPhase 1/Phase 2
The Novo Nordic FoundationPhase 4
Jacob Pontoppidan ThyssenPhase 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 CREAM;TOPICAL 215985-002 Jul 9, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Zydus Pharms ROFLUMILAST roflumilast TABLET;ORAL 208303-002 Apr 18, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-001 Jul 29, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Arcutis ZORYVE roflumilast FOAM;TOPICAL 217242-001 Dec 15, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd ROFLUMILAST roflumilast TABLET;ORAL 213298-001 Apr 17, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-002 Jul 9, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Arcutis ZORYVE roflumilast FOAM;TOPICAL 217242-001 Dec 15, 2023 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 roflumilast

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 022522-001 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
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 ⤷  Sign Up ⤷  Sign Up
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 ⤷  Sign Up ⤷  Sign Up
>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
South Korea 101179012 ⤷  Sign Up
Japan 2006519818 ⤷  Sign Up
China 108992673 罗氟司特晶体生长的抑制 (Inhibition of crystal growth of roflumilast) ⤷  Sign Up
Iceland 2723 ⤷  Sign Up
Australia 2021393513 TOPICAL ROFLUMILAST FORMULATION HAVING ANTIFUNGAL PROPERTIES ⤷  Sign Up
China 115551478 具有改善递送和血浆半衰期的罗氟司特局部制剂 (Topical formulations of roflumilast with improved delivery and plasma half-life) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2004080967 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for roflumilast

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 1090034-8 Sweden ⤷  Sign Up PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705
1606261 PA2010010,C1606261 Lithuania ⤷  Sign Up PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
1606261 C20100008 00033 Estonia ⤷  Sign Up PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
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
1606261 PA2010010 Lithuania ⤷  Sign Up PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
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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