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Last Updated: October 5, 2022

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 Akorn, Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane. and is included in twenty-one NDAs.

The generic ingredient in ACETYLCYSTEINE is acetylcysteine. There are three drug master file entries for this compound. Twelve 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

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Recent Clinical Trials for ACETYLCYSTEINE

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University of HoustonPhase 3
University of Wisconsin, MadisonPhase 3
Massachusetts Eye and Ear InfirmaryPhase 3

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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
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
Roxane ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072323-001 Apr 30, 1992 DISCN No No See Plans and Pricing See Plans and Pricing 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
Exela Pharma ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 204797-001 Apr 15, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Am Regent ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072489-001 Jul 28, 1995 AN RX No Yes 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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School

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.