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Harvard Business School
Mallinckrodt
Healthtrust
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Generated: October 21, 2017

DrugPatentWatch Database Preview

Acetylcysteine - Generic Drug Details

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What are the generic drug sources for acetylcysteine and what is the scope of acetylcysteine patent protection?

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 eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetylcysteine 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

US Patents:8
Tradenames:7
Applicants:13
NDAs:22
Drug Master File Entries: see list3
Suppliers / Packagers: see list10
Bulk Api Vendors: see list89
Clinical Trials: see list257
Patent Applications: see list7,668
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:acetylcysteine at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc
CETYLEV
acetylcysteine
TABLET, EFFERVESCENT;ORAL207916-002Jan 29, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Apothecon
MUCOMYST
acetylcysteine
SOLUTION;INHALATION, ORAL013601-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Hospira
ACETYLCYSTEINE
acetylcysteine
SOLUTION;INHALATION, ORAL073664-001Aug 30, 1994ANRXNoNo► Subscribe► Subscribe► Subscribe
Cumberland Pharms
ACETADOTE
acetylcysteine
INJECTABLE;INTRAVENOUS021539-001Jan 23, 2004APRXYesYes► Subscribe► Subscribe ► Subscribe
Dey
MUCOSIL-10
acetylcysteine
SOLUTION;INHALATION, ORAL070575-001Oct 14, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Arbor Pharms Llc
CETYLEV
acetylcysteine
TABLET, EFFERVESCENT;ORAL207916-001Jan 29, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Cumberland Pharms
ACETADOTE
acetylcysteine
INJECTABLE;INTRAVENOUS021539-001Jan 23, 2004APRXYesYes► Subscribe► SubscribeY ► Subscribe
Akorn Inc
ACETYLCYSTEINE
acetylcysteine
INJECTABLE;INTRAVENOUS203173-001Mar 24, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Dey
MUCOSIL-20
acetylcysteine
SOLUTION;INHALATION, ORAL070576-001Oct 14, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Mead Johnson
MUCOMYST W/ ISOPROTERENOL
acetylcysteine; isoproterenol hydrochloride
SOLUTION;INHALATION017366-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► 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
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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
Canada2619441► Subscribe
World Intellectual Property Organization (WIPO)2012012640► Subscribe
China103038356► Subscribe
New Zealand566100► Subscribe
China102266316► Subscribe
Australia2006282030► Subscribe
South Korea20080047398► Subscribe
World Intellectual Property Organization (WIPO)2007024311► Subscribe
European Patent Office1928449► 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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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Cipla
Cerilliant
Medtronic
McKesson
Johnson and Johnson
Farmers Insurance
Daiichi Sankyo
Mallinckrodt
Express Scripts

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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