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Last Updated: August 4, 2020

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ACETYLCYSTEINE - Generic Drug Details

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What are the generic sources for acetylcysteine and what is the scope of freedom to operate?

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 Inc, Zydus Pharms, Alvogen Inc, Am Regent, Hospira, Roxane, Apothecon, DEY, Arbor Pharms Llc, and Mead Johnson, and is included in twenty-four 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. Eleven suppliers are listed for this compound.

Drug Prices for ACETYLCYSTEINE

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Recent Clinical Trials for ACETYLCYSTEINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
David TangPhase 4
Johns Hopkins UniversityPhase 2
Massachusetts Eye and Ear InfirmaryPhase 2

See all ACETYLCYSTEINE clinical trials

Medical Subject Heading (MeSH) Categories for ACETYLCYSTEINE
Paragraph IV (Patent) Challenges for ACETYLCYSTEINE
Tradename Dosage Ingredient NDA Submissiondate
ACETADOTE INJECTABLE;INTRAVENOUS acetylcysteine 021539 2012-04-04

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
Dey MUCOSIL-20 acetylcysteine SOLUTION;INHALATION, ORAL 070576-001 Oct 14, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-002 Jan 29, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Hospira ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 071364-001 May 1, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Akorn Inc ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 203173-001 Mar 24, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Roxane ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072324-001 Apr 30, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Dow
Baxter
Colorcon
McKinsey

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