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Last Updated: August 11, 2020

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CETYLEV Drug Profile

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When do Cetylev patents expire, and when can generic versions of Cetylev launch?

Cetylev is a drug marketed by Arbor Pharms Llc and is included in one NDA. There are three patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in CETYLEV 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 Cetylev

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

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Drug patent expirations by year for CETYLEV
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Recent Clinical Trials for CETYLEV

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SponsorPhase
University of MarylandPhase 1/Phase 2

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US Patents and Regulatory Information for CETYLEV

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-002 Jan 29, 2016 DISCN Yes No   Start Trial   Start Trial   Start Trial
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-001 Jan 29, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-002 Jan 29, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-002 Jan 29, 2016 DISCN Yes No   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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