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Last Updated: December 9, 2019

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Dextromethorphan hydrobromide; guaifenesin - Generic Drug Details

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

Dextromethorphan hydrobromide; guaifenesin is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma Ltd, Perrigo R And D, and Rb Hlth, and is included in five 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-three drug master file entries for dextromethorphan hydrobromide; guaifenesin. Fifty-four suppliers are listed for this compound.

Summary for dextromethorphan hydrobromide; guaifenesin
Recent Litigation for dextromethorphan hydrobromide; guaifenesin

Identify potential future generic entrants

District Court Litigation
Case NameDate
RECKITT BENCKISER LLC v. AMNEAL PHARMACEUTICALS LLC2015-03-26
Reckitt Benckiser LLC v. Aurobindo Pharma Limited2014-09-17
Adams Respiratory Therapeutics, Inc. v. Perrigo Company2007-10-02

See all dextromethorphan hydrobromide; guaifenesin litigation

Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Tradename Dosage Ingredient NDA Submissiondate
MUCINEX DM TABLET, EXTENDED RELEASE;ORAL dextromethorphan hydrobromide; guaifenesin 021620 2008-12-17

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
Perrigo R And D GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 207602-001 Mar 5, 2018 OTC No No   Start Trial   Start Trial   Start Trial
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes No   Start Trial   Start Trial Y   Start Trial
Aurobindo Pharma Ltd GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 206941-002 Mar 17, 2017 OTC No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 091070-002 Aug 31, 2015 OTC No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for dextromethorphan hydrobromide; guaifenesin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539166 2013C/064 Belgium   Start Trial PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
1539166 60/2013 Austria   Start Trial 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
1539166 CA 2013 00059 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1539166 13C0062 France   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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