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Acetylcysteine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for acetylcysteine?

Acetylcysteine is the generic ingredient in seven branded drugs marketed by Apothecon, Arbor Pharms Llc, Roxane, Mylan Institutional, Hospira, Cumberland Pharms, Fresenius Kabi Usa, Luitpold, Alvogen Inc, Aurobindo Pharma Ltd, Akorn Inc, DEY, and Mead Johnson, and is included in twenty-two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has eighteen patent family members in ten countries.

There are three drug master file entries for acetylcysteine. Ten suppliers are listed for this compound.

Summary for Generic Name: acetylcysteine

Tradenames:7
Patents:8
Applicants:13
NDAs:22
Drug Master File Entries: see list3
Suppliers / Packagers: see list10
Bulk Api Vendors: see list89
Clinical Trials: see list95
Patent Applications: see list7,580
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:acetylcysteine at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Luitpold
ACETYLCYSTEINE
acetylcysteine
SOLUTION;INHALATION, ORAL072547-001Jul 28, 1995RXNoYes► Subscribe► Subscribe
Fresenius Kabi Usa
ACETYLCYSTEINE
acetylcysteine
INJECTABLE;INTRAVENOUS200644-001Nov 7, 2012RXNoNo► Subscribe► Subscribe
Arbor Pharms Llc
CETYLEV
acetylcysteine
TABLET, EFFERVESCENT;ORAL207916-002Jan 29, 2016RXYesYes9,427,421► SubscribeY ► Subscribe
Cumberland Pharms
ACETADOTE
acetylcysteine
INJECTABLE;INTRAVENOUS021539-001Jan 23, 2004RXYesYes8,148,356► SubscribeY ► Subscribe
Hospira
ACETYLCYSTEINE
acetylcysteine
SOLUTION;INHALATION, ORAL071365-001May 1, 1989DISCNNoNo► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: acetylcysteine

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
8,952,065Acetylcysteine composition and uses thereof► Subscribe
9,561,204Effervescent compositions containing N-acetylcysteine► 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 Ingredient: acetylcysteine

Country Document Number Estimated Expiration
European Patent Office2662077► Subscribe
World Intellectual Property Organization (WIPO)2007024311► Subscribe
World Intellectual Property Organization (WIPO)2012012640► Subscribe
Canada2619441► Subscribe
European Patent Office2596112► 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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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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