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Serving leading biopharmaceutical companies globally:

UBS
Fuji
Baxter
Deloitte
Argus Health
McKesson
US Army
Fish and Richardson
Novartis
Medtronic

Generated: December 12, 2017

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Roflumilast - Generic Drug Details

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What are the generic sources for roflumilast and what is the scope of roflumilast freedom to operate?

Roflumilast
is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Roflumilast has one hundred and twenty-three patent family members in forty-four countries and twelve supplementary protection certificates in eleven countries.

There are eight drug master file entries for roflumilast. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for roflumilast

Tentative approvals for ROFLUMILAST

Applicant Application No. Strength Dosage Form
u► Subscribe500MCGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsDALIRESProflumilastTABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: roflumilast

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 Ingredient: roflumilast

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2004080967► Subscribe
China1635909► Subscribe
TaiwanI363636► Subscribe
Taiwan200508201► Subscribe
China1046939► Subscribe
China100471840► Subscribe
Iceland7810► Subscribe
Japan3093271► Subscribe
Brazil0307739► Subscribe
South Korea20100103729► 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: ROFLUMILAST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
/2010Austria► SubscribePRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705
2010 00028Denmark► Subscribe
2010010,C1606261Lithuania► SubscribePRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
709Luxembourg► Subscribe91709, EXPIRES: 20190702
C031/2010Ireland► SubscribeSPC031/2010: 20110906, EXPIRES: 20190701
0706513/01Switzerland► SubscribeFORMER OWNER: NYCOMED GERMANY HOLDING GMBH, DE
90034-8Sweden► SubscribePRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705
0100008 00033Estonia► SubscribePRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Teva
Mallinckrodt
Boehringer Ingelheim
Harvard Business School
Fish and Richardson
UBS
Medtronic
Julphar
QuintilesIMS
Baxter

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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