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Generated: February 23, 2018

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Dextromethorphan hydrobromide; guaifenesin - Generic Drug Details

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What are the generic drug sources for dextromethorphan hydrobromide; guaifenesin and what is the scope of dextromethorphan hydrobromide; guaifenesin freedom to operate?

Dextromethorphan hydrobromide; guaifenesin
is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Aurobindo Pharma Ltd, and Reckitt Benckiser, and is included in three NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dextromethorphan hydrobromide; guaifenesin has thirty-nine patent family members in nineteen countries.

There are twenty-two drug master file entries for dextromethorphan hydrobromide; guaifenesin. Forty-three suppliers are listed for this compound.
Summary for dextromethorphan hydrobromide; guaifenesin

US Patents and Regulatory Information for dextromethorphan hydrobromide; guaifenesin

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Aurobindo Pharma Ltd GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 206941-001 Mar 17, 2017 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Actavis Labs Fl GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 091070-001 Aug 31, 2015 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Aurobindo Pharma Ltd GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 206941-002 Mar 17, 2017 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Actavis Labs Fl GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 091070-002 Aug 31, 2015 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Non-Orange Book US Patents for dextromethorphan hydrobromide; guaifenesin

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
7,985,420 Sustained release of guaifenesin combination drugs ➤ Sign Up
7,985,421 Sustained release formulations of guaifenesin and additional drug ingredients ➤ Sign Up
8,012,504 Sustained release of guaifenesin combination drugs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for dextromethorphan hydrobromide; guaifenesin

Supplementary Protection Certificates for dextromethorphan hydrobromide; guaifenesin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/055 Ireland ➤ Sign Up 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 ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
C0062 France ➤ Sign Up 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
/2013 Austria ➤ Sign Up PRODUCT 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
2013 00059 Denmark ➤ Sign Up PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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