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Last Updated: December 14, 2024

ACETADOTE Drug Patent Profile


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Which patents cover Acetadote, and what generic alternatives are available?

Acetadote is a drug marketed by Cumberland Pharms and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in eleven countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Acetadote

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

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Drug patent expirations by year for ACETADOTE
Drug Prices for ACETADOTE

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Recent Clinical Trials for ACETADOTE

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SponsorPhase
University of Missouri-ColumbiaPhase 1
Shandong Provincial HospitalPhase 1
Central South UniversityPhase 1

See all ACETADOTE clinical trials

Paragraph IV (Patent) Challenges for ACETADOTE
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 ACETADOTE

ACETADOTE is protected by five US patents.

Patents protecting ACETADOTE

Acetylcysteine composition and uses therefor
Patent Number: 8,148,356
Patent Expiration: ⤷  Subscribe

Acetylcysteine composition and uses thereof
Patent Number: 8,399,445
Patent Expiration: ⤷  Subscribe
Patented Use: METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

Acetylcysteine composition and uses thereof
Patent Number: 8,653,061
Patent Expiration: ⤷  Subscribe
Patented Use: METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

Acetycysteine compositions and methods of use thereof
Patent Number: 8,722,738
Patent Expiration: ⤷  Subscribe
Patented Use: METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

Acetylcysteine compositions and methods of use thereof
Patent Number: 9,327,028
Patent Expiration: ⤷  Subscribe
Patented Use: COMPOSITION AND METHOD FOR PROVIDING A REDUCTION IN SIDE EFFECTS FOR HUMAN PATIENTS IN NEED OF ACETYLCYSTEINE THERAPY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes 8,399,445 ⤷  Subscribe ⤷  Subscribe
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes 8,722,738 ⤷  Subscribe ⤷  Subscribe
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes 9,327,028 ⤷  Subscribe ⤷  Subscribe
>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.