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Baxter
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McKinsey
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Farmers Insurance
Daiichi Sankyo
Johnson and Johnson
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Generated: February 19, 2019

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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 ten 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 ➤ 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 ➤ 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 Date
➤ Subscribe Tablets 500 mcg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for DALIRESP

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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:

Cipla
Daiichi Sankyo
Mallinckrodt
Express Scripts
Chubb
Chinese Patent Office
UBS
McKesson
Merck

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