DrugPatentWatch Database Preview

Roflumilast - Generic Drug Details

What are the generic drug sources for roflumilast and what is the scope of roflumilast patent protection?

Roflumilast is the generic ingredient in two branded drugs marketed by Astrazeneca Pharms, Breckenridge Pharm, Mylan Pharms Inc, and Torrent Pharms Ltd, and is included in four NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

US Patents:	6
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	10
Suppliers / Packagers:	3
Bulk Api Vendors:	97
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
➤ Sign Up	➤ Sign Up	500MCG	TABLET;ORAL

US Patents and Regulatory Information for roflumilast

+ Get email alerts for changes to this table

Glossary

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Pharms	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Astrazeneca Pharms	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	AB	RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Astrazeneca Pharms	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

International Patents for roflumilast

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial
Country	Document Number	Estimated Expiration
Japan	3093271	➤ Sign Up
Luxembourg	91709	➤ Sign Up
South Korea	20050106392	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for roflumilast

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0052	France	➤ Sign Up	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
2010 00028	Denmark	➤ Sign Up
0706513/01	Switzerland	➤ Sign Up	FORMER OWNER: NYCOMED GERMANY HOLDING GMBH, DE
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description