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Last Updated: July 13, 2020

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ACETADOTE Drug 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 seventeen patent family members in ten countries.

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

US ANDA 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
Mercy Medical CenterPhase 1/Phase 2
Wake Forest UniversityPhase 1/Phase 2
St George Hospital, AustraliaPhase 1/Phase 2

See all ACETADOTE clinical trials

Paragraph IV (Patent) Challenges for ACETADOTE
Tradename Dosage Ingredient NDA Submissiondate
ACETADOTE INJECTABLE;INTRAVENOUS acetylcysteine 021539 2012-04-04

US Patents and Regulatory Information for ACETADOTE

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   Start Trial   Start Trial   Start Trial
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes   Start Trial   Start Trial Y   Start 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
AstraZeneca
Merck
Express Scripts
Moodys

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