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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Teva
US Department of Justice
McKesson
Medtronic
Baxter
Mallinckrodt
Covington

Generated: May 25, 2018

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MUCINEX DM Drug Profile

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When do Mucinex Dm patents expire, 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.

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

US Patents and Regulatory Information for MUCINEX DM

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;ORAL 021620-002 Apr 29, 2004 OTC Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free 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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Paragraph IV (Patent) Challenges for MUCINEX DM
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 600 mg/30 mg and 1200 mg/60 mg ➤ Subscribe 2008-12-17

Non-Orange Book US Patents for 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
8,012,504 Sustained release of guaifenesin combination drugs ➤ Try a Free Trial
7,985,420 Sustained release of guaifenesin combination drugs ➤ Try a Free Trial
7,985,421 Sustained release formulations of guaifenesin and additional drug ingredients ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for MUCINEX DM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/055 Ireland ➤ Try a Free Trial PRODUCT 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
323 Luxembourg ➤ Try a Free Trial PRODUCT 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 00059 Denmark ➤ Try a Free Trial PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
C0062 France ➤ Try a Free Trial PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Fuji
Covington
Cantor Fitzgerald
Argus Health
Chinese Patent Office
Farmers Insurance
Daiichi Sankyo
Express Scripts

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