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Last Updated: July 29, 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 freedom to operate?

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
Paulista School of Medicine-EPM, UNIFESPPhase 3
CearĂ¡ Health Secretariat - SESAPhase 3
Leonardo da Vinci Hospital - HLVPhase 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
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Aurobindo Pharma Ltd ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 207358-001 Feb 29, 2016 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-002 Jan 29, 2016 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mead Johnson MUCOMYST W/ ISOPROTERENOL acetylcysteine; isoproterenol hydrochloride SOLUTION;INHALATION 017366-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Alvogen ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 203853-001 Jun 21, 2012 AN 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

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Dow
Baxter
Colorcon
McKinsey

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