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Last Updated: September 30, 2020

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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.

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 Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,399,445
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;

Drugs Protected by US Patent 8,399,445

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes   Start Trial   Start Trial METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,399,445

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2006282030   Start Trial
Canada 2619441   Start Trial
China 101242824   Start Trial
China 102266316   Start Trial
European Patent Office 1928449   Start Trial
Hong Kong 1123972   Start Trial
Japan 2009506030   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Johnson and Johnson
McKesson
Colorcon
McKinsey

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