.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries

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

Serving leading biopharmaceutical companies globally:

Merck
QuintilesIMS
Medtronic
Harvard Business School
AstraZeneca
McKinsey
Deloitte
Accenture
McKesson
Daiichi Sankyo

Generated: December 12, 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 Cumberland Pharms, Akorn Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms, Alvogen Inc, Hospira, Luitpold, Roxane, Apothecon, DEY, Arbor Pharms Llc, and Mead Johnson, and is included in twenty-three 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.

Medical Subject Heading (MeSH) Categories for acetylcysteine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Akorn IncACETYLCYSTEINEacetylcysteineINJECTABLE;INTRAVENOUS203173-001Mar 24, 2015APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
ApotheconMUCOMYSTacetylcysteineSOLUTION;INHALATION, ORAL013601-002Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Cumberland PharmsACETADOTEacetylcysteineINJECTABLE;INTRAVENOUS021539-001Jan 23, 2004APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Arbor Pharms LlcCETYLEVacetylcysteineTABLET, EFFERVESCENT;ORAL207916-002Jan 29, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Mylan InstitutionalACETYLCYSTEINEacetylcysteineINJECTABLE;INTRAVENOUS203624-001Jun 19, 2015APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Arbor Pharms LlcCETYLEVacetylcysteineTABLET, EFFERVESCENT;ORAL207916-002Jan 29, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Cumberland PharmsACETADOTEacetylcysteineINJECTABLE;INTRAVENOUS021539-001Jan 23, 2004APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Arbor Pharms LlcCETYLEVacetylcysteineTABLET, EFFERVESCENT;ORAL207916-002Jan 29, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Arbor Pharms LlcCETYLEVacetylcysteineTABLET, EFFERVESCENT;ORAL207916-001Jan 29, 2016RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
HospiraACETYLCYSTEINEacetylcysteineSOLUTION;INHALATION, ORAL071364-001May 1, 1989DISCNNoNo► Subscribe► 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
Australia2011281035► Subscribe
Canada2619441► Subscribe
South Korea101408336► Subscribe
Japan5303272► Subscribe
China103038356► Subscribe
Philippines12012501687► Subscribe
Australia2006282030► Subscribe
South Korea20080047398► Subscribe
European Patent Office2596112► Subscribe
World Intellectual Property Organization (WIPO)2007024311► 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 plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
Moodys
Merck
Dow
Accenture
AstraZeneca
Argus Health
Deloitte
Federal Trade Commission
Cerilliant

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
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot