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Serving leading biopharmaceutical companies globally:

Queensland Health
QuintilesIMS
Moodys
Citi
Colorcon
Cerilliant
Accenture
Julphar
Deloitte
McKinsey

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,399,445

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Which drugs does patent 8,399,445 protect, and when does it expire?


Patent 8,399,445 protects ACETADOTE and is included in one NDA. There has been one Paragraph IV challenge on Acetadote.

This patent has thirteen patent family members in ten countries.

Summary for Patent: 8,399,445

Title:Acetylcysteine composition and uses thereof
Abstract: This invention relates to novel acetylcysteine compositions in solution, comprising acetylcysteine and which are substantially free of metal chelating agents, such as EDTA. Further, this invention relates to methods of making and using the acetylcysteine compositions. The present compositions and methods are designed to improve patient tolerance and compliance, while at the same time maintaining the stability of the pharmaceutical formulation. The compositions and methods of this invention are useful in the treatment of acetaminophen overdose, acute liver failure, various cancers, methacrylonitrile poisoning, reperfusion injury during cardio bypass surgery, and radiocontrast-induced nephropathy, and can also be used as a mucolytic agent.
Inventor(s): Pavliv; Leo (Cary, NC)
Assignee: Cumberland Pharmaceuticals, Inc. (Nashville, TN)
Application Number:13/406,175
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Cumberland PharmsACETADOTEacetylcysteineINJECTABLE;INTRAVENOUS021539-001Jan 23, 2004APRXYesYes► Subscribe► Subscribe► SubscribeMETHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
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Non-Orange Book Patents for Patent: 8,399,445

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
8,148,356Acetylcysteine composition and uses therefor► Subscribe
8,952,065Acetylcysteine composition and uses thereof► Subscribe
8,653,061Acetylcysteine composition and uses thereof► 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: 8,399,445

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Philippines12012501687► Subscribe
New Zealand566100► Subscribe
South Korea101408336► Subscribe
South Korea20080047398► Subscribe
Japan5303272► Subscribe
Japan2009506030► Subscribe
Hong Kong1123972► Subscribe
European Patent Office1928449► Subscribe
China102266316► Subscribe
China101242824► 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:

Express Scripts
Dow
Daiichi Sankyo
Novartis
US Department of Justice
Citi
Cerilliant
Julphar
Boehringer Ingelheim
Federal Trade Commission

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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