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Last Updated: March 19, 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
Apothecon MUCOMYST acetylcysteine SOLUTION;INHALATION, ORAL 013601-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Indoco ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 215620-001 Feb 23, 2022 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
Hospira ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 073664-001 Aug 30, 1994 AN RX 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
European Patent Office 2662077 COMPOSITION EFFERVESCENTE CONTENANT DE LA N-ACÉTYL-CYSTÉINE (EFFERVESCENT COMPOSITIONS CONTAINING N-ACETYLCYSTEINE) ⤷  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
European Patent Office 1928449 COMPOSITION D'ACETYLCYSTEINE ET SES UTILISATIONS (ACETYLCYSTEINE COMPOSITION AND USES THEREFOR) ⤷  Try a Trial
Japan 2009506030 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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