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Last Updated: March 29, 2024

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, Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Steriscience, Zydus Pharms, Alvogen, Am Regent, Hospira, Roxane, Apothecon, DEY, Arbor Pharms Llc, and Mead Johnson, and is included in twenty-eight 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. Fifteen suppliers are listed for this compound. There is one tentative approval 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
University of Alabama at BirminghamEarly Phase 1
Sanjay Gandhi Postgraduate Institute of Medical SciencesPhase 3
Assiut UniversityPhase 1

See all acetylcysteine clinical trials

Generic filers with tentative approvals for ACETYLCYSTEINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial6GM/30ML (200MG/ML)INJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Zydus Pharms ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 208166-001 Jul 20, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-002 Jan 29, 2016 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Exela Pharma ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 205643-001 Nov 1, 2023 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072622-001 Sep 30, 1992 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 203173-001 Mar 24, 2015 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 200644-001 Nov 7, 2012 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072323-001 Apr 30, 1992 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
South Korea 20080047398 ACETYLCYSTEINE COMPOSITION AND USES THEREFOR ⤷  Try a Trial
Japan 2009506030 ⤷  Try a Trial
Australia 2006282030 Acetylcysteine composition and uses therefor ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2012012640 ⤷  Try a Trial
New Zealand 566100 Acetylcysteine composition and uses therefor ⤷  Try a Trial
European Patent Office 1928449 COMPOSITION D'ACETYLCYSTEINE ET SES UTILISATIONS (ACETYLCYSTEINE COMPOSITION AND USES THEREFOR) ⤷  Try a Trial
Hong Kong 1123972 乙酰半胱氨酸組合物及其用途 (ACETYLCYSTEINE COMPOSITION AND USES THEREFOR) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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