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Serving 500+ biopharmaceutical companies globally:

Chubb
Cantor Fitzgerald
Colorcon
Mallinckrodt
Deloitte
Argus Health
Healthtrust
Cipla
Farmers Insurance
Merck

Generated: June 26, 2017

DrugPatentWatch Database Preview

MUCINEX D Drug Profile

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What is the patent landscape for Mucinex D, and when can generic versions of Mucinex D launch?

Mucinex D is a drug marketed by Reckitt Benckiser and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in nineteen countries.

The generic ingredient in MUCINEX D is dextromethorphan hydrobromide; guaifenesin. There are twenty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.

Summary for Tradename: MUCINEX D

Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list4
Clinical Trials: see list7
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:MUCINEX D at DailyMed

Pharmacology for Tradename: MUCINEX D

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Reckitt Benckiser
MUCINEX D
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021585-002Jun 22, 2004OTCYesYes6,372,252► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-002Apr 29, 2004OTCYesNo7,838,032► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX D
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021585-001Jun 22, 2004OTCYesNo6,372,252► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-001Apr 29, 2004OTCYesYes6,955,821► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-002Apr 29, 2004OTCYesNo6,372,252► SubscribeY ► Subscribe
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Paragraph IV activity for: MUCINEX D

Drugname Dosage Strength RLD Submissiondate
guaifenesin and dextromethorphanExtended-release Tablets600 mg/30 mg and 1200 mg/60 mgMucinex DM12/17/2008

Non-Orange Book Patents for Tradename: MUCINEX D

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
7,985,420Sustained release of guaifenesin combination drugs► Subscribe
8,012,504Sustained release of guaifenesin combination drugs► Subscribe
7,985,421Sustained release formulations of guaifenesin and additional drug ingredients► 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: MUCINEX D

Country Document Number Estimated Expiration
Taiwan200727919► Subscribe
New Zealand562286► Subscribe
TaiwanI326602► Subscribe
Israel152012► Subscribe
Japan2003531849► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Moodys
US Department of Justice
Queensland Health
Boehringer Ingelheim
Harvard Business School
Accenture
Baxter
UBS
US Army
Teva

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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