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CETYLEV Drug Profile

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Which patents cover Cetylev, and what substitute generic drugs are available?

Cetylev is a drug marketed by Arbor Pharms Llc and is included in one NDA. There are two 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. Ten suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

Summary for Tradename: CETYLEV

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:CETYLEV at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc
CETYLEV
acetylcysteine
TABLET, EFFERVESCENT;ORAL207916-002Jan 29, 2016RXYesYes8,747,894► SubscribeY ► Subscribe
Arbor Pharms Llc
CETYLEV
acetylcysteine
TABLET, EFFERVESCENT;ORAL207916-001Jan 29, 2016RXYesNo9,427,421► SubscribeY ► Subscribe
Arbor Pharms Llc
CETYLEV
acetylcysteine
TABLET, EFFERVESCENT;ORAL207916-002Jan 29, 2016RXYesYes9,427,421► SubscribeY ► Subscribe
Arbor Pharms Llc
CETYLEV
acetylcysteine
TABLET, EFFERVESCENT;ORAL207916-001Jan 29, 2016RXYesNo8,747,894► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: CETYLEV

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,561,204Effervescent compositions containing N-acetylcysteine► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: CETYLEV

Country Document Number Estimated Expiration
European Patent Office2662077► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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