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Last Updated: August 14, 2022

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, Akorn, Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Zydus Pharms, Alvogen, Am Regent, Hospira, Roxane, Apothecon, DEY, Arbor Pharms Llc, and Mead Johnson, and is included in twenty-seven 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. Twelve suppliers are listed 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
Sydney Local Health DistrictPhase 4
National Health and Medical Research Council, AustraliaPhase 4
South West Sydney Local Health DistrictPhase 4

See all ACETYLCYSTEINE clinical trials

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
Hospira ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 073664-001 Aug 30, 1994 AN RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aspen ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 213693-001 Feb 3, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dey MUCOSIL-20 acetylcysteine SOLUTION;INHALATION, ORAL 070576-001 Oct 14, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eugia Pharma ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 207358-001 Feb 29, 2016 AP RX No No 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

International Patents for ACETYLCYSTEINE

Country Patent Number Title Estimated Expiration
China 102266316 See Plans and Pricing
European Patent Office 2596112 COMPOSITIONS D'ACÉTYLCYSTÉINE ET MÉTHODES D'UTILISATION CORRESPONDANTES (ACETYCYSTEINE COMPOSITIONS AND METHODS OF USE THEREOF) See Plans and Pricing
European Patent Office 1928449 COMPOSITION D'ACETYLCYSTEINE ET SES UTILISATIONS (ACETYLCYSTEINE COMPOSITION AND USES THEREFOR) See Plans and Pricing
Japan 5303272 See Plans and Pricing
Australia 2011281035 Acetycysteine compositions and methods of use thereof See Plans and Pricing
World Intellectual Property Organization (WIPO) 2012012640 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Dow
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Colorcon
McKinsey

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.