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Serving leading biopharmaceutical companies globally:

Healthtrust
QuintilesIMS
Deloitte
Argus Health
Cerilliant
US Army
Harvard Business School
Cipla
Moodys
Fish and Richardson

Generated: February 21, 2018

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 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

US Patents and Regulatory Information for acetylcysteine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Luitpold ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072547-001 Jul 28, 1995 AN RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mead Johnson MUCOMYST W/ ISOPROTERENOL acetylcysteine; isoproterenol hydrochloride SOLUTION;INHALATION 017366-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-002 Jan 29, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hospira ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 074037-001 Aug 30, 1994 AN RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-001 Jan 29, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-001 Jan 29, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Akorn Inc ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 203173-001 Mar 24, 2015 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 207358-001 Feb 29, 2016 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,952,065 Acetylcysteine composition and uses thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for acetylcysteine

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Express Scripts
UBS
Chinese Patent Office
Daiichi Sankyo
Johnson and Johnson
AstraZeneca
Mallinckrodt
US Army

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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