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Last Updated: August 3, 2021

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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 patent protection?

Acetylcysteine is the generic ingredient in seven branded drugs marketed by Cumberland Pharms, Akorn, Aurobindo Pharma Ltd, Exela Pharma, Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms Inc, Zydus Pharms, Alvogen, Am Regent, Hospira, Roxane, Apothecon, DEY, Arbor Pharms Llc, and Mead Johnson, and is included in twenty-five 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. Twelve suppliers are listed for this compound.

Drug Prices for acetylcysteine

See drug prices for acetylcysteine

Recent Clinical Trials for acetylcysteine

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

SponsorPhase
Central Laboratory of Public Health of Ceara - LACEN-CEPhase 3
Municipal Health Secretary - SMS-FortalezaPhase 3
Universidade Federal do CearaPhase 3

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
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-002 Jan 29, 2016 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Apothecon MUCOMYST acetylcysteine SOLUTION;INHALATION, ORAL 013601-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Roxane ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072621-001 Sep 30, 1992 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hospira ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 073664-001 Aug 30, 1994 AN RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hospira ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 071364-001 May 1, 1989 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Fresenius Kabi Usa ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 200644-001 Nov 7, 2012 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Moodys
Dow
Johnson and Johnson
McKesson

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