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Last Updated: October 25, 2020

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Which patents cover Acetylcysteine, and when can generic versions of Acetylcysteine launch?

Acetylcysteine is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms Inc, Zydus Pharms, Alvogen Inc, Am Regent, Hospira, and Roxane. and is included in eighteen NDAs.

The generic ingredient in ACETYLCYSTEINE is acetylcysteine. There are three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

US ANDA Litigation and Generic Entry Outlook for Acetylcysteine

A generic version of ACETYLCYSTEINE was approved as acetylcysteine by HOSPIRA on August 30th, 1994.

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Drug patent expirations by year for ACETYLCYSTEINE

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Recent Clinical Trials for ACETYLCYSTEINE

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

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
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 072622-001 Sep 30, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Alvogen Inc ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 204674-001 Feb 11, 2014 AN RX No No   Start Trial   Start Trial   Start Trial
Mylan Institutional ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 203624-001 Jun 19, 2015 DISCN No No   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:

Express Scripts
Harvard Business School

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