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Serving 500+ biopharmaceutical companies globally:

Teva
Citi
Cerilliant
Colorcon
Argus Health
Chinese Patent Office
Dow
Moodys
Harvard Business School
Chubb

Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,604,064

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Which drugs does patent 8,604,064 protect, and when does it expire?


Patent 8,604,064 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: 8,604,064

Title:Process for the preparation of roflumilast
Abstract: A method for the treatment of chronic obstructive pulmonary disease (COPD), including administering to a patient suffering from COPD, a therapeutically effective amount of roflumilast having a purity of greater than or equal to 99% by weight, and N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount greater than zero and less than 0.1% by weight.
Inventor(s): Kohl; Bernhard (Constance, DE), Mueller; Bernd (Constance, DE), Palosch; Walter (Rielasingen, DE)
Assignee: Takeda GmbH (Constance, DE)
Application Number:13/860,248
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, 2011RXYesYes8,604,064► 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: 8,604,064

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
03005245Mar 10, 2003

Non-Orange Book Patents for Patent: 8,604,064

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
8,536,206Process 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: 8,604,064

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Norway20051957► Subscribe
MexicoPA04008070► Subscribe
South Korea101179012► Subscribe
South Korea20050106392► Subscribe
Japan4742026► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Teva
Baxter
Fuji
QuintilesIMS
Farmers Insurance
Cerilliant
Chubb
Boehringer Ingelheim
Johnson and Johnson
Queensland 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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