Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
Baxter
Johnson and Johnson
US Department of Justice
Medtronic
Cerilliant
Queensland Health
Healthtrust
Julphar
Farmers Insurance

Generated: August 22, 2017

DrugPatentWatch Database Preview

Acetylcysteine - Generic Drug Details

« Back to Dashboard

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

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 list255
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon
MUCOMYST
acetylcysteine
SOLUTION;INHALATION, ORAL013601-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Cumberland Pharms
ACETADOTE
acetylcysteine
INJECTABLE;INTRAVENOUS021539-001Jan 23, 2004APRXYesYes► Subscribe► SubscribeY ► Subscribe
Hospira
ACETYLCYSTEINE
acetylcysteine
SOLUTION;INHALATION, ORAL071365-001May 1, 1989DISCNNoNo► Subscribe► Subscribe► Subscribe
Roxane
ACETYLCYSTEINE
acetylcysteine
SOLUTION;INHALATION, ORAL072621-001Sep 30, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Roxane
ACETYLCYSTEINE
acetylcysteine
SOLUTION;INHALATION, ORAL072622-001Sep 30, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: acetylcysteine

Country Document Number Estimated Expiration
European Patent Office2662077► Subscribe
New Zealand566100► Subscribe
European Patent Office2596112► Subscribe
Hong Kong1123972► Subscribe
China103038356► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Merck
Fish and Richardson
QuintilesIMS
Cerilliant
Moodys
Mallinckrodt
Medtronic
Fuji
Cipla
Novartis

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot