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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 roflumilast freedom to operate?

Roflumilast is the generic ingredient in two branded drugs marketed by Astrazeneca Pharms, Breckenridge Pharm, Hetero Labs Ltd Iii, Mylan Pharms Inc, and Torrent Pharms Ltd, and is included in five 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-three patent family members in forty-four countries.

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

Summary for roflumilast

International Patents:	123
US Patents:	6
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	10
Suppliers / Packagers:	3
Bulk Api Vendors:	102
Clinical Trials:	66
Patent Applications:	5,860
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for roflumilast
DailyMed Link:	roflumilast at DailyMed

Pharmacology for roflumilast

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Synonyms for roflumilast

0P6C6ZOP5U

162401-32-3

1xmu

1xoq

3-(Cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)benzamide

3-(cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridyl)-4-(difluoromethoxy)benzamide

3-(CYCLOPROPYLMETHOXY)-N-(3,5-DICHLOROPYRIDIN-4-YL)-4-(DIFLUOROMETHOXY)BENZAMIDE

3-cyclopropylmethoxy-4-difluoromethoxy-N-(3,5-di-chloropyrid-4-yl)benzamide

3-CyclopropylMethoxy-N-(3,5-dichloro-pyridin-4-yl)-4-isopropoxy-benzaMide

3-Cyclopropylmethoxy-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide

3-CYCLOPROPYLOMETHOXY-N-(3,5 DICHLOROPYRIDIN-4-YL)-4-DIFLUORO-METHOXYBENZAMIDE

3g4l

401R323

A24672

AB0031354

AB01565852_02

AB1008459

AC-23383

AC1L9MU7

ACM1189992004

ACT02619

AJ-23633

AK110425

AKOS005146309

Alogliptin/roflumilast

AM84550

AN-552

API0004090

APTA-2217

AS-14120

AX8150494

B 9302-107

B9302-107

BCP0726000146

BDBM14774

BEN530

Benzamide, 3-(cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)-

Benzamide, 3-(cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)-

BRD-K03194791-001-02-2

BY 217

BY-217

BY217

BYK-20869

BYK20869

C17H14Cl2F2N2O3

cc-305

CHEBI:47657

CHEMBL193240

CR0025

CS-0963

CTK8E9183

D05744

D07GBA

D0R4UW

Daliresp

Daliresp (TN)

DAXAS

DB01656

DR002373

DTXSID8044123

EBD15341

EX-A059

FC0016

FT-0660846

GTPL6962

HE316208

HMS3655P21

HY-15455

I14-15194

J-510858

KS-00000792

Libertek

LS-26272

MFCD00938270

MLS006010074

MNDBXUUTURYVHR-UHFFFAOYSA-N

MolPort-006-069-128

n-(3,5-dichloropyridin-4-yl)-4-difluoromethoxy-3-cyclopropylmethoxybenzamide

NCGC00346566-01

PB29130

Q-4353

QC-1593

R0193

RL02084

ROF

Roflumilast (Daxas)

Roflumilast (JAN/USAN/INN)

Roflumilast [USAN:INN]

Roflumilast [USAN]

Roflumilast, >=98% (HPLC)

Roflumilast;

RoflumilastDaxas

roflumilastum

RT-015436

s2131

SCHEMBL19158

SMR002530074

ST24049127

UNII-0P6C6ZOP5U

X4421

ZB014504

ZINC592419

Tentative approvals for ROFLUMILAST

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

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
Torrent Pharms Ltd	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
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			Y
Hetero Labs Ltd Iii	ROFLUMILAST	roflumilast	TABLET;ORAL	208213-001	Nov 23, 2018	AB	RX	No	No
Astrazeneca Pharms	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	AB	RX	Yes	Yes

International Patents for roflumilast

Country	Document Number	Estimated Expiration
Cyprus	1109580
Japan	2006519818
Hong Kong	1011690
Peru	08232003
Canada	2503290
Norway	20043904

Supplementary Protection Certificates for roflumilast

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2010010,C1606261	Lithuania		PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
/2010	Austria		PRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705
709	Luxembourg		91709, EXPIRES: 20190702
90034-8	Sweden		PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705
C031/2010	Ireland		SPC031/2010: 20110906, EXPIRES: 20190701
2010010	Lithuania		PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705