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Serving 500+ biopharmaceutical companies globally:

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Generated: June 28, 2017

DrugPatentWatch Database Preview

Guaifenesin; pseudoephedrine hydrochloride - Generic Drug Details

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What are the generic sources for guaifenesin; pseudoephedrine hydrochloride and what is the scope of guaifenesin; pseudoephedrine hydrochloride patent protection?

Guaifenesin; pseudoephedrine hydrochloride
is the generic ingredient in two branded drugs marketed by Actavis Labs Fl and Reckitt Benckiser, and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Guaifenesin; pseudoephedrine hydrochloride has thirty-seven patent family members in nineteen countries.

There are twenty drug master file entries for guaifenesin; pseudoephedrine hydrochloride. Nineteen suppliers are listed for this compound.

Summary for Generic Name: guaifenesin; pseudoephedrine hydrochloride

Tradenames:2
Patents:4
Applicants:2
NDAs:2
Drug Master File Entries: see list20
Suppliers / Packagers: see list19
Clinical Trials: see list2,300
Drug Prices:see low prices
DailyMed Link:guaifenesin; pseudoephedrine hydrochloride at DailyMed

Pharmacology for Ingredient: guaifenesin; pseudoephedrine hydrochloride

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 D
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021585-001Jun 22, 2004OTCYesNo6,955,821► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX D
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021585-002Jun 22, 2004OTCYesYes6,372,252► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX D
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021585-002Jun 22, 2004OTCYesYes7,838,032► SubscribeY ► Subscribe
Actavis Labs Fl
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL091071-002May 27, 2015OTCNoNo► Subscribe► Subscribe
Reckitt Benckiser
MUCINEX D
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021585-001Jun 22, 2004OTCYesNo7,838,032► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: guaifenesin; pseudoephedrine hydrochloride

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 Ingredient: guaifenesin; pseudoephedrine hydrochloride

Country Document Number Estimated Expiration
New Zealand561044► Subscribe
Spain2301537► Subscribe
TaiwanI359034► Subscribe
Israel152012► Subscribe
Taiwan200727919► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Teva
Healthtrust
Harvard Business School
Colorcon
Federal Trade Commission
Boehringer Ingelheim
Daiichi Sankyo
Medtronic
Novartis

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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