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Serving leading biopharmaceutical companies globally:

US Army
Merck
Harvard Business School
McKesson
Deloitte
AstraZeneca
Novartis
Citi
QuintilesIMS
Mallinckrodt

Generated: October 20, 2017

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 and twelve supplementary protection certificates in eleven countries.

The generic ingredient in DALIRESP is roflumilast. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the roflumilast profile page.

Summary for Tradename: DALIRESP

US Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list75
Clinical Trials: see list10
Patent Applications: see list3,250
Drug Prices:see details
DailyMed Link:DALIRESP at DailyMed

Pharmacology for Tradename: 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;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Pharms
DALIRESP
roflumilast
TABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
DALIRESP
roflumilast
TABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Pharms
DALIRESP
roflumilast
TABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Pharms
DALIRESP
roflumilast
TABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Pharms
DALIRESP
roflumilast
TABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Pharms
DALIRESP
roflumilast
TABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for DALIRESP

Drugname Dosage Strength RLD Submissiondate
roflumilastTablets500 mcgDaliresp3/2/2015

Non-Orange Book Patents for Tradename: 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
7,951,397Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient► Subscribe
7,470,791Process for the preparation of roflumilast► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: DALIRESP

Country Document Number Estimated Expiration
Iceland7810► Subscribe
Ukraine84266► Subscribe
South Africa200406644► Subscribe
Japan4742026► Subscribe
European Patent Office1606261► Subscribe
Portugal2258394► Subscribe
Slovakia283263► Subscribe
Germany10207160► Subscribe
Japan2005517724► Subscribe
Germany59410119► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DALIRESP

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010010,C1606261Lithuania► SubscribePRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
90034-8Sweden► SubscribePRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705
2010010Lithuania► SubscribePRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
709Luxembourg► Subscribe91709, EXPIRES: 20190702
C031/2010Ireland► SubscribeSPC031/2010: 20110906, EXPIRES: 20190701
/2010Austria► SubscribePRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705
C0052France► SubscribePRODUCT 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 00028Denmark► Subscribe
0706513/01Switzerland► SubscribeFORMER OWNER: NYCOMED GERMANY HOLDING GMBH, DE
00462Netherlands► SubscribePRODUCT NAME: ROFLUMILAST, DESGEWENST IN DE VORM VAN HET N-OXIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Army
Chinese Patent Office
Boehringer Ingelheim
Healthtrust
Cerilliant
Cipla
Julphar
Farmers Insurance
US Department of Justice

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.

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