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Last Updated: April 19, 2024

ACETYLCYSTEINE Drug Patent Profile


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Which patents cover Acetylcysteine, and when can generic versions of Acetylcysteine launch?

Acetylcysteine is a drug marketed by Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Steriscience, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane. and is included in twenty-two NDAs.

The generic ingredient in ACETYLCYSTEINE is acetylcysteine. There are three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Acetylcysteine

A generic version of ACETYLCYSTEINE was approved as acetylcysteine by HOSPIRA on August 30th, 1994.

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Drug patent expirations by year for ACETYLCYSTEINE
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

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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
Aspen ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 213693-001 Feb 3, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 074037-001 Aug 30, 1994 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sagent Pharms Inc ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 091684-001 Oct 31, 2017 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
Am Regent ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072489-001 Jul 28, 1995 AN RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072621-001 Sep 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

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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.