Roflumilast - Generic Drug Details

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

International Patents:	111
US Patents:	9
Tradenames:	3
Applicants:	11
NDAs:	11
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	93
Patent Applications:	6,689
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for roflumilast
What excipients (inactive ingredients) are in roflumilast?	roflumilast excipients list
DailyMed Link:	roflumilast at DailyMed

Recent Clinical Trials for roflumilast

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

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

See all roflumilast clinical trials

Generic filers with tentative approvals for ROFLUMILAST

Applicant	Application No.	Strength	Dosage Form
		500MCG	TABLET;ORAL
		500MCG	TABLET;ORAL
		250MCG	TABLET;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

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

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
Msn	ROFLUMILAST	roflumilast	TABLET;ORAL	208256-001	Sep 7, 2022	AB	RX	No	No
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-001	Jul 29, 2022		RX	Yes	Yes			Y
Zydus Pharms	ROFLUMILAST	roflumilast	TABLET;ORAL	208303-001	Feb 10, 2022	AB	RX	No	No
Mylan	ROFLUMILAST	roflumilast	TABLET;ORAL	208257-001	Jul 13, 2018	AB	RX	No	No
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	AB	RX	Yes	Yes
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	AB	RX	Yes	No			Y

Expired US Patents for roflumilast

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011

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

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)
South Korea	20050106392	NOVEL PROCESS FOR THE PREPARATION OF ROFLUMILAST
Slovenia	2258394
South Africa	200503191	Novel process for the preparation of roflumilast.
Peru	20030823	FORMA DE DOSIFICACION QUE CONTIENE UN INHIBIDOR DE LA PDE 4 COMO INGREDIENTE ACTIVO
Japan	4163120
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)

Supplementary Protection Certificates for roflumilast

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0706513	C300462	Netherlands		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		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		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		PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
0706513	1090034-8	Sweden		PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705
0706513	34/2010	Austria		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		PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705