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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Express Scripts
AstraZeneca
Covington
Daiichi Sankyo
Cantor Fitzgerald
Cipla
Julphar
Healthtrust

Generated: July 15, 2018

DrugPatentWatch Database Preview

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 one branded drug marketed by Astrazeneca Pharms and is included in one NDA. 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 nine drug master file entries for roflumilast. Two suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for roflumilast
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
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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
Astrazeneca Pharms DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 RX Yes Yes ➤ 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

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Non-Orange Book US Patents for roflumilast

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,470,791 Process for the preparation of roflumilast ➤ Sign Up
7,951,397 Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for roflumilast

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010010,C1606261 Lithuania ➤ Sign Up PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
C031/2010 Ireland ➤ Sign Up SPC031/2010: 20110906, EXPIRES: 20190701
0706513/01 Switzerland ➤ Sign Up FORMER OWNER: NYCOMED GERMANY HOLDING GMBH, DE
/2010 Austria ➤ Sign Up PRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Argus Health
Dow
Medtronic
Colorcon
Merck
Healthtrust
Chinese Patent Office
Federal Trade Commission

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