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Details for Patent: 9,327,028

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Patent 9,327,028 protects ACETADOTE and is included in one NDA. There has been one Paragraph IV challenge on Acetadote.

This patent has four patent family members in four countries.

Summary for Patent: 9,327,028

Title:Acetylcysteine compositions and methods of use thereof
Abstract: A pharmaceutical composition and method for providing a reduction in side effects for human patients in need of therapy comprising the administration of a pharmaceutical composition comprising acetylcysteine is disclosed.
Inventor(s): Pavliv; Leo (Cary, NC), Rock; Amy (Thompsons Station, TN)
Assignee: Cumberland Pharmaceuticals, Inc. (Nashville, TN)
Application Number:14/225,345
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Cumberland Pharms
ACETADOTE
acetylcysteine
INJECTABLE;INTRAVENOUS021539-001Jan 23, 2004RXYes9,327,028► subscribe COMPOSITION AND METHOD FOR PROVIDING A REDUCTION IN SIDE EFFECTS FOR HUMAN PATIENTS IN NEED OF ACETYLCYSTEINE THERAPY
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Non-Orange Book Patents for Patent: 9,327,028

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
8,722,738Acetycysteine compositions and methods of use 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: 9,327,028

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office2596112► subscribe
China103038356► subscribe
Australia2011281035► 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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