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Last Updated: January 27, 2023

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, Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Zydus Pharms, Alvogen, Am Regent, Hospira, Roxane, Apothecon, DEY, Arbor Pharms Llc, and Mead Johnson, and is included in twenty-seven 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 nineteen patent family members in eleven countries.

There are three drug master file entries for acetylcysteine. Thirteen 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

Medical College of WisconsinPhase 3
University College London HospitalsPhase 3
University of MiamiPhase 3

See all acetylcysteine clinical trials

Medical Subject Heading (MeSH) Categories for acetylcysteine
Paragraph IV (Patent) Challenges for ACETYLCYSTEINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ACETADOTE Injection acetylcysteine 200 mg/mL, 30 mL vials 021539 3 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
Apothecon MUCOMYST acetylcysteine SOLUTION;INHALATION, ORAL 013601-002 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-002 Jan 29, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rising ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 203624-001 Jun 19, 2015 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Roxane ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072621-001 Sep 30, 1992 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 203173-001 Mar 24, 2015 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alvogen ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 204674-001 Feb 11, 2014 AN RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for acetylcysteine

Country Patent Number Title Estimated Expiration
Japan 5303272 See Plans and Pricing
New Zealand 566100 Acetylcysteine composition and uses therefor See Plans and Pricing
World Intellectual Property Organization (WIPO) 2007024311 See Plans and Pricing
South Korea 101408336 See Plans and Pricing
Japan 2009506030 See Plans and Pricing
South Korea 20080047398 ACETYLCYSTEINE COMPOSITION AND USES THEREFOR See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

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 verification 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.