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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cantor Fitzgerald
Fuji
Cerilliant
Deloitte
Julphar
Covington
AstraZeneca
QuintilesIMS
Harvard Business School

Generated: December 15, 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. Two suppliers are listed for this compound. Additional details are available on the roflumilast profile page.

Summary for DALIRESP

Drug patent expirations by year for DALIRESP

Pharmacology for DALIRESP

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe► 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
Eurasian Patent Organization200401019► Subscribe
Iceland2723► Subscribe
Eurasian Patent Organization200501350► Subscribe
Denmark0706513► Subscribe
Denmark1478399► Subscribe
JapanH08512041► Subscribe
Germany122010000043► Subscribe
Ukraine84266► Subscribe
Norway332844► Subscribe
South Korea101179012► 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
0100008 00033Estonia► SubscribePRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
0706513/01Switzerland► SubscribeFORMER OWNER: NYCOMED GERMANY HOLDING GMBH, DE
709Luxembourg► Subscribe91709, EXPIRES: 20190702
2010010Lithuania► 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
2010 00028Denmark► Subscribe
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
C/GB10/040United Kingdom► SubscribePRODUCT 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
/2010Austria► SubscribePRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705
2010010,C1606261Lithuania► SubscribePRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Covington
Dow
Medtronic
Accenture
Novartis
Merck
Queensland Health
Cantor Fitzgerald
Argus Health

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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