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MUCINEX DM Drug Profile

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Mucinex Dm is a drug marketed by Reckitt Benckiser and is included in one NDA. It is available from seven suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

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

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

Summary for Tradename: MUCINEX DM

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list7
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-002Apr 29, 2004OTCNo6,955,821► subscribeY ► subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-001Apr 29, 2004OTCYes6,955,821► subscribeY ► subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-002Apr 29, 2004OTCNo6,372,252► subscribeY ► subscribe
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Paragraph IV activity for: MUCINEX DM

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 DM

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 DM

Country Document Number Estimated Expiration
Germany60133538► subscribe
Japan2005528402► subscribe
China1655766► 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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Supplementary Protection Certificates for Tradename: MUCINEX DM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/055Ireland► subscribePRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624
2013 00059Denmark► subscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
323Luxembourg► subscribePRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624
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