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Generated: October 20, 2017

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MUCINEX DM Drug Profile

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

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

This drug has thirty-nine patent family members in nineteen countries and six supplementary protection certificates in five countries.

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

Summary for Tradename: MUCINEX DM

US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list8
Clinical Trials: see list7
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:MUCINEX DM at DailyMed
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 DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-002Apr 29, 2004OTCYesNo► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-001Apr 29, 2004OTCYesYes► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-002Apr 29, 2004OTCYesNo► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-002Apr 29, 2004OTCYesNo► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-001Apr 29, 2004OTCYesYes► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-001Apr 29, 2004OTCYesYes► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges 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
Denmark1276467► Subscribe
Taiwan200733952► Subscribe
Cyprus1108166► Subscribe
China1655766► Subscribe
Portugal1276467► Subscribe
Austria391494► Subscribe
European Patent Office1276467► Subscribe
Japan5466346► Subscribe
TaiwanI359034► 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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Supplementary Protection Certificates for Tradename: MUCINEX DM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00059Denmark► SubscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
C0062France► SubscribePRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
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
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
2013 00059Denmark► SubscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
/2013Austria► SubscribePRODUCT NAME: KOMBINATION VON A) DEXTROMETHORPHAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE DEXTROMETHORPHANHYDROBROMID, UND INSBESONDERE DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT UND B) CHINIDIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE CHINIDINSULFAT, UND INSBESONDERE CHINIDINSULFATDIHYDRAT.; REGISTRATION NO/DATE: EU/1/13/833 20130626
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Serving leading biopharmaceutical companies globally:

Novartis
Chubb
Healthtrust
QuintilesIMS
Teva
Johnson and Johnson
Baxter
Chinese Patent Office
Covington
McKesson

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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