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 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.

Summary for ROFLUMILAST

International Patents:	85
US Patents:	16
Tradenames:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	99
Patent Applications:	7,299
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
The Novo Nordic Foundation	Phase 4
Jacob Pontoppidan Thyssen	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
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-002	Jul 9, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Arcutis	ZORYVE	roflumilast	FOAM;TOPICAL	217242-001	Dec 15, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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

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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	⤷ 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
>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
Canada	3162675	FORMULATION TOPIQUE DE ROFLUMILAST PRESENTANT DES PROPRIETES ANTIFONGIQUES (TOPICAL ROFLUMILAST FORMULATION HAVING ANTIFUNGAL PROPERTIES)	⤷ Sign Up
Canada	3166300	FORMULATION DE ROFLUMILAST TOPIQUE AYANT UNE ADMINISTRATION ET UNE DEMI-VIE PLASMATIQUE AMELIOREES (TOPICAL ROFLUMILAST FORMULATION HAVING IMPROVED DELIVERY AND PLASMA HALF-LIFE)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2021045804		⤷ Sign Up
>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
0706513	1090034-8	Sweden	⤷ Sign Up	PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 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
1606261	PA2010010	Lithuania	⤷ Sign Up	PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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