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, 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 thirteen 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 one hundred and seventeen patent family members in thirty-six countries.

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

Summary for roflumilast

International Patents:	117
US Patents:	10
Tradenames:	3
Applicants:	13
NDAs:	13
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	99
Patent Applications:	7,026
Drug Prices:	Drug price trends for roflumilast
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

See drug prices for roflumilast

Recent Clinical Trials for roflumilast

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

Sponsor	Phase
Mansoura University	Phase 1/Phase 2
Jacob Pontoppidan Thyssen	Phase 4
The Novo Nordic Foundation	Phase 4

See all roflumilast clinical trials

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
Hetero Labs Ltd Iii	ROFLUMILAST	roflumilast	TABLET;ORAL	208213-001	Nov 23, 2018	AB	RX	No	No
Torrent	ROFLUMILAST	roflumilast	TABLET;ORAL	208272-001	Aug 6, 2018		DISCN	No	No
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	AB	RX	Yes	No			Y
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	AB	RX	Yes	No			Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-001	Jul 29, 2022		RX	Yes	Yes

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
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018

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
Malaysia	140561	DOSAGE FORM CONTAINING PDE 4 INHIBITOR AS ACTIVE INGREDIENT
South Korea	20200016940	로플루밀라스트의 결정 성장의 저해
Spain	2335498
Canada	2503290	NOUVEAU PROCEDE DE PREPARATION DE ROFLUMILAST (NOVEL PROCESS FOR THE PREPARATION OF ROFLUMILAST)
Poland	370595

Supplementary Protection Certificates for roflumilast

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1606261	PA2010010,C1606261	Lithuania		PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
1606261	PA2010010	Lithuania		PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
0706513	10C0052	France		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	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