Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Deloitte
UBS
Covington
Argus Health
Merck
Federal Trade Commission
AstraZeneca
Harvard Business School

Generated: August 21, 2018

DrugPatentWatch Database Preview

DALIRESP Drug Profile

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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
Generic Entry Opportunity Date for DALIRESP
Generic Entry Date for DALIRESP*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Astrazeneca Pharms DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Pharms DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Pharms DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Paragraph IV (Patent) Challenges for DALIRESP
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 500 mcg ➤ Subscribe ➤ Try a Free Trial

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 ➤ Try a Free Trial
7,470,791 Process for the preparation of roflumilast ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Supplementary Protection Certificates for DALIRESP

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010010,C1606261 Lithuania ➤ Try a Free Trial PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
C0052 France ➤ Try a Free Trial 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
C/GB10/040 United Kingdom ➤ Try a Free Trial PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXIDE AND THE SALTS OF THESE COMPOUNDS.; REGISTERED: UK EU/1/10/636/001 20100705; UK EU/1/10/636/002 20100705; UK EU/1/10/636/003 20100705
709 Luxembourg ➤ Try a Free Trial 91709, EXPIRES: 20190702
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Army
Johnson and Johnson
Chinese Patent Office
Fish and Richardson
Colorcon
McKinsey
Moodys
Fuji

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.