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Guaifenesin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for guaifenesin?

Guaifenesin is the generic ingredient in seven branded drugs marketed by Actavis Labs Fl Inc, Perrigo R And D, Reckitt Benckiser, Mission Pharmacal Co, and Sovereign Pharms, and is included in eight 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-six patent family members in nineteen countries.

There are twenty drug master file entries for guaifenesin. Forty-seven suppliers are listed for this compound.

Summary for Generic Name: guaifenesin

Tradenames:7
Patents:4
Applicants:5
NDAs:8
Drug Master File Entries: see list20
Suppliers / Packagers: see list47
Bulk Api Vendors: see list65
Clinical Trials: see list6
Patent Applications: see list2,576
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:guaifenesin at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date 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
guaifenesin
TABLET, EXTENDED RELEASE;ORAL021282-001Jul 12, 2002OTCYesNo7,838,032► SubscribeY ► Subscribe
Actavis Labs Fl Inc
GUAIFENESIN
guaifenesin
TABLET, EXTENDED RELEASE;ORAL091009-002Sep 3, 2015OTCNoNo► Subscribe► Subscribe
Actavis Labs Fl Inc
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL091071-002May 27, 2015OTCNoNo► Subscribe► Subscribe
Mission Pharmacal Co
FLOWTUSS
guaifenesin; hydrocodone bitartrate
SOLUTION;ORAL022424-001May 14, 2015RXNoNo► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
7,985,421Sustained release formulations of guaifenesin and additional drug ingredients► Subscribe
7,985,420Sustained release of guaifenesin combination drugs► 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

Country Document Number Estimated Expiration
European Patent Office1913937► Subscribe
European Patent Office1276467► Subscribe
TaiwanI282285► Subscribe
New Zealand521959► Subscribe
Canada2481739► 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.

Export unavailable in trial.
Subscribe for complete access.

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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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