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Last Updated: May 1, 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.

Summary for ROFLUMILAST

International Patents:	78
US Patents:	10
Tradenames:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	13
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

Anatomical Therapeutic Chemical (ATC) Classes for ROFLUMILAST

D05AX	Other antipsoriatics for topical use
D05A	ANTIPSORIATICS FOR TOPICAL USE
D05	ANTIPSORIATICS
D	Dermatologicals

R03DX	Other systemic drugs for obstructive airway diseases
R03D	OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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
Hetero Labs Ltd Iii	ROFLUMILAST	roflumilast	TABLET;ORAL	208213-001	Nov 23, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	ROFLUMILAST	roflumilast	TABLET;ORAL	208303-002	Apr 18, 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
Alkem Labs Ltd	ROFLUMILAST	roflumilast	TABLET;ORAL	212490-002	Apr 18, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	AB	RX	Yes	Yes	⤷ 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
>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

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

EU/EMA Drug Approvals for ROFLUMILAST

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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

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Country	Patent Number	Title	Estimated Expiration
Japan	7242222		⤷ Try a Trial
Mexico	2019014741	INHIBICION DEL CRECIMIENTO DE CRISTALES DE ROFLUMILAST. (INHIBITION OF CRYSTAL GROWTH OF ROFLUMILAST.)	⤷ Try a Trial
Canada	3162675	FORMULATION TOPIQUE DE ROFLUMILAST PRESENTANT DES PROPRIETES ANTIFONGIQUES (TOPICAL ROFLUMILAST FORMULATION HAVING ANTIFUNGAL PROPERTIES)	⤷ Try a Trial
Serbia	52908	NOVI POSTUPAK ZA DOBIJANJE ROFLUMILASTA (NOVEL PROCESS FOR THE PREPARATION OF ROFLUMILAST)	⤷ Try a Trial
Montenegro	00524	NOVI POSTUPAK ZA DOBIJANJE ROFLUMILASTA (NOVEL PROCESS FOR THE PREPARATION OF ROFLUMILAST)	⤷ Try a Trial
Argentina	043531	PROCEDIMIENTO PARA LA PREPARACION DE N-(3, 5-DICLOROPIDID-4-IL)-3-CICLOPROPILMETOXI-4-DIFLUOROMETOXIBENZAMIDA (INN: ROFLUMILAST)	⤷ Try a Trial
Croatia	P20050399	NOVEL PROCESS FOR THE PREPARATION OF ROFLUMILAST	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ROFLUMILAST

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1606261	C20100008 00033	Estonia	⤷ Try a Trial	PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
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
0706513	SPC/GB10/040	United Kingdom	⤷ Try a Trial	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	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
1606261	PA2010010,C1606261	Lithuania	⤷ Try a Trial	PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
0706513	34/2010	Austria	⤷ Try a Trial	PRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.