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Dextromethorphan hydrobromide; guaifenesin - Generic Drug Details

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

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

There are twenty-two drug master file entries for dextromethorphan hydrobromide; guaifenesin. Twenty-eight suppliers are listed for this compound.

Summary for Generic Name: dextromethorphan hydrobromide; guaifenesin

Tradenames:2
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: see list22
Suppliers / Packaging: see list28
Formulation / Manufacturing:see details
Drug Prices:see low prices
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;ORAL021620-001Apr 29, 2004OTCYes6,372,252► 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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Non-Orange Book Patents for Generic Ingredient: 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
8,012,504Sustained release of guaifenesin combination drugs► subscribe
7,985,420Sustained 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 Ingredient: dextromethorphan hydrobromide; guaifenesin

Country Document Number Estimated Expiration
Canada2405031► subscribe
World Intellectual Property Organization (WIPO)0182895► subscribe
TaiwanI326602► 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: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/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
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 ET EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
2013 00059Denmark► subscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
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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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