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Serving hundreds of leading biopharmaceutical companies globally:

UBS
QuintilesIMS
Daiichi Sankyo
Chinese Patent Office
Citi
Covington
Julphar
Argus Health
Cantor Fitzgerald

Generated: May 26, 2018

DrugPatentWatch Database Preview

DALIRESP Drug Profile

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Which patents cover Daliresp, and when can generic versions of Daliresp launch?

Daliresp is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-three patent family members in forty-four countries.

The generic ingredient in DALIRESP is roflumilast. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
Drug patent expirations by year for DALIRESP
Pharmacology for DALIRESP
Synonyms for DALIRESP
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 (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
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

US Patents and Regulatory Information for DALIRESP

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 Y ➤ Sign Up
Astrazeneca Pharms DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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 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

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Paragraph IV (Patent) Challenges for DALIRESP
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 500 mcg ➤ Subscribe 2015-03-02

Non-Orange Book US Patents for DALIRESP

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

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Supplementary Protection Certificates for DALIRESP

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C031/2010 Ireland ➤ Sign Up SPC031/2010: 20110906, EXPIRES: 20190701
0100008 00033 Estonia ➤ Sign Up PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
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
2010010,C1606261 Lithuania ➤ Sign Up PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Baxter
Citi
Chubb
Julphar
Fish and Richardson
Colorcon
Queensland Health
QuintilesIMS

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