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Serving leading biopharmaceutical companies globally:

Express Scripts
Queensland Health
Colorcon
Federal Trade Commission
McKinsey
Mallinckrodt
QuintilesIMS
Chinese Patent Office
Boehringer Ingelheim
Novartis

Generated: December 15, 2017

DrugPatentWatch Database Preview

MUCINEX Drug Profile

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Which patents cover Mucinex, and when can generic versions of Mucinex launch?

Mucinex is a drug marketed by Reckitt Benckiser and is included in three NDAs. There are three patents protecting this drug and three Paragraph IV challenges.

This drug has thirty-nine patent family members in nineteen countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Reckitt BenckiserMUCINEXguaifenesinTABLET, EXTENDED RELEASE;ORAL021282-002Dec 18, 2002OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEX DMdextromethorphan hydrobromide; guaifenesinTABLET, EXTENDED RELEASE;ORAL021620-001Apr 29, 2004OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEX Dguaifenesin; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021585-002Jun 22, 2004OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEXguaifenesinTABLET, EXTENDED RELEASE;ORAL021282-001Jul 12, 2002OTCYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEX Dguaifenesin; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021585-001Jun 22, 2004OTCYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEX Dguaifenesin; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021585-002Jun 22, 2004OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEX DMdextromethorphan hydrobromide; guaifenesinTABLET, EXTENDED RELEASE;ORAL021620-001Apr 29, 2004OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEX DMdextromethorphan hydrobromide; guaifenesinTABLET, EXTENDED RELEASE;ORAL021620-002Apr 29, 2004OTCYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEXguaifenesinTABLET, EXTENDED RELEASE;ORAL021282-002Dec 18, 2002OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEXguaifenesinTABLET, EXTENDED RELEASE;ORAL021282-002Dec 18, 2002OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for MUCINEX

Drugname Dosage Strength RLD Submissiondate
guaifenesin and pseudoephedrine hydrochlorideExtended-release Tablets600 mg/60 mg and 1200 mg/120 mgMucinex-D12/29/2008
guaifenesin and dextromethorphanExtended-release Tablets600 mg/30 mg and 1200 mg/60 mgMucinex DM12/17/2008
guaifenesinExtended-release Tablets600 mg and 1.2 gmMucinex6/9/2006

Non-Orange Book Patents for Tradename: MUCINEX

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

Country Document Number Estimated Expiration
Germany60133538► Subscribe
Denmark1276467► Subscribe
Hong Kong1052651► Subscribe
TaiwanI326602► Subscribe
Canada2481739► Subscribe
Austria391494► Subscribe
Israel152012► Subscribe
South Africa200409171► Subscribe
TaiwanI314866► Subscribe
European Patent Office1276467► 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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Serving leading biopharmaceutical companies globally:

Cerilliant
Fish and Richardson
Chinese Patent Office
QuintilesIMS
Merck
Boehringer Ingelheim
Cipla
Colorcon
Novartis
Federal Trade Commission

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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