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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Harvard Business School
Daiichi Sankyo
Novartis
Healthtrust
Medtronic
Baxter
McKinsey
Teva
Colorcon

Generated: October 17, 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.

Summary for Generic Name: roflumilast

US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list8
Suppliers / Packagers: see list3
Bulk Api Vendors: see list76
Clinical Trials: see list62
Patent Applications: see list5,610
Drug Prices:see low prices
DailyMed Link:roflumilast at DailyMed

Pharmacology for Ingredient: 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 Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
DALIRESP
roflumilast
TABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
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► SubscribeY ► Subscribe
Astrazeneca Pharms
DALIRESP
roflumilast
TABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► SubscribeY ► 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
7,470,791Process for the preparation of roflumilast► Subscribe
7,951,397Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient► 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
European Patent Office1606261► Subscribe
South Korea101386843► Subscribe
Cyprus1112811► Subscribe
HungaryT73232► Subscribe
Slovenia1606261► Subscribe
Germany59410119► Subscribe
Japan4163120► Subscribe
TaiwanI363636► Subscribe
World Intellectual Property Organization (WIPO)9501338► Subscribe
Spain2424634► 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
2010 00028Denmark► Subscribe
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
90034-8Sweden► SubscribePRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: 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
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
2010010,C1606261Lithuania► SubscribePRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 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
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:

Queensland Health
Farmers Insurance
Mallinckrodt
Baxter
Dow
AstraZeneca
Teva
Novartis
Colorcon
McKinsey

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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