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Serving leading biopharmaceutical companies globally:

UBS
Farmers Insurance
McKesson
Dow
Chinese Patent Office
Fuji
Novartis
AstraZeneca
McKinsey
Cerilliant

Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,617,595

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Which drugs does patent 8,617,595 protect, and when does it expire?


Patent 8,617,595 protects TEKTURNA and is included in one NDA. There has been one Paragraph IV challenge on Tekturna.

Protection for TEKTURNA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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

Summary for Patent: 8,617,595

Title:Galenic formulations of organic compounds
Abstract: The present invention relates to a solid oral dosage form comprising a therapeutically effective amount of aliskiren or a pharmaceutically acceptable salt thereof, and wherein the active ingredient is present in an amount of more than 46% by weight based on the total weight of the oral dosage form.
Inventor(s): Rigassi-Dietrich; Petra G (Therwil, CH), Schmid; Martin (Wettingen, CH)
Assignee: Novartis AG (Basel, CH)
Application Number:10/590,398
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Use; Formulation; Process; Use; Formulation; Compound; Process; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Noden Pharma
TEKTURNA
aliskiren hemifumarate
TABLET;ORAL021985-001Mar 5, 2007RXYesNo► Subscribe► SubscribeY
Noden Pharma
TEKTURNA
aliskiren hemifumarate
TABLET;ORAL021985-002Mar 5, 2007RXYesYes► Subscribe► SubscribeY
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Foreign Priority and PCT Information for Patent: 8,617,595

PCT Information
PCT FiledMarch 16, 2005PCT Application Number:PCT/EP2005/002798
PCT Publication Date:September 29, 2005PCT Publication Number: WO2005/089729

Non-Orange Book Patents for Patent: 8,617,595

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
7,683,054Galenic formulations of organic compounds► Subscribe
8,007,824Galenic formulations of organic compounds► 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: 8,617,595

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina048431► Subscribe
Australia2005224010► Subscribe
Australia2009202069► Subscribe
BrazilPI0508833► Subscribe
Canada2554633► Subscribe
China103462913► Subscribe
China1997354► Subscribe
EcuadorSP066807► Subscribe
European Patent Office1729736► Subscribe
European Patent Office2283826► 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:

McKesson
Dow
Mallinckrodt
Accenture
Farmers Insurance
Deloitte
Julphar
Chinese Patent Office
Baxter
Merck

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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