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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 two branded drugs marketed by Astrazeneca Pharms, Breckenridge, Hetero Labs Ltd Iii, Micro Labs, Mylan, Strides Pharma, and Torrent, and is included in seven NDAs. There are six 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 twenty-six patent family members in forty-four countries.

There are ten drug master file entries for roflumilast. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for roflumilast

International Patents:	126
US Patents:	6
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	10
Suppliers / Packagers:	1
Bulk Api Vendors:	115
Clinical Trials:	79
Patent Applications:	6,932
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for roflumilast
DailyMed Link:	roflumilast at DailyMed

Recent Clinical Trials for roflumilast

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

Sponsor	Phase
Chiesi Farmaceutici S.p.A.	Phase 3
Bispebjerg Hospital	Phase 2
University of Calgary	Phase 1

See all roflumilast clinical trials

Generic filers with tentative approvals for ROFLUMILAST

Applicant	Application No.	Strength	Dosage Form
		500MCG	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	NDA	Submissiondate
DALIRESP	TABLET;ORAL	roflumilast	022522	2019-01-25
DALIRESP	TABLET;ORAL	roflumilast	022522	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	AB	RX	No	No
Astrazeneca Pharms	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	AB	RX	Yes	Yes			Y
Torrent	ROFLUMILAST	roflumilast	TABLET;ORAL	208272-001	Aug 6, 2018	AB	RX	No	No
Astrazeneca Pharms	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	AB	RX	Yes	Yes			Y
Astrazeneca Pharms	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018		RX	Yes	No

Expired US Patents for roflumilast

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

International Patents for roflumilast

Country	Patent Number	Estimated Expiration
Norway	20043904
South Korea	101179012
World Intellectual Property Organization (WIPO)	9501338
China	102764242
European Patent Office	2258394

Supplementary Protection Certificates for roflumilast

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	CA 2010 00028	Denmark