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Last Updated: February 28, 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

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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
Steriscience ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 217182-001 Apr 19, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aspen ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 213693-001 Feb 3, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alvogen ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 203853-001 Jun 21, 2012 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

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