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Serving leading biopharmaceutical companies globally:

Fuji
Chubb
Moodys
Cipla
Colorcon
Baxter
Federal Trade Commission
Deloitte
Dow
Boehringer Ingelheim

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,536,206

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Which drugs does patent 8,536,206 protect, and when does it expire?


Patent 8,536,206 protects DALIRESP and is included in one NDA. There has been one Paragraph IV challenge on Daliresp.

This patent has thirty-two patent family members in twenty-seven countries.

Summary for Patent: 8,536,206

Title:Process for the preparation of roflumilast
Abstract: The invention relates to novel processes for the preparation of high-purity roflumilast.
Inventor(s): Kohl; Bernhard (Constance, DE), Mueller; Bernd (Constance, DE), Palosch; Walter (Rielasingen, DE)
Assignee: Takeda GmbH (Konstanz, DE)
Application Number:13/547,945
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form; Formulation;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Astrazeneca Pharms
DALIRESP
roflumilast
TABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► Subscribe TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
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Foreign Priority and PCT Information for Patent: 8,536,206

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
03005245Mar 08, 2003

Non-Orange Book Patents for Patent: 8,536,206

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
8,618,142Process for the preparation of roflumilast► Subscribe
8,604,064Process 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 Patent: 8,536,206

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Eurasian Patent Organization009985► Subscribe
European Patent Office1606261► SubscribePA2010010Lithuania► Subscribe
European Patent Office1606261► SubscribeC20100008 00033Estonia► Subscribe
European Patent Office1606261► SubscribePA2010010,C1606261Lithuania► Subscribe
Spain2335498► Subscribe
Hong Kong1085480► Subscribe
CroatiaP20050399► Subscribe
Eurasian Patent Organization200501350► Subscribe
Israel168170► Subscribe
Iceland7810► 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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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Teva
Queensland Health
Medtronic
Merck
Covington
Fish and Richardson
UBS
Daiichi Sankyo

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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