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Serving leading biopharmaceutical companies globally:

Colorcon
Julphar
Express Scripts
Moodys
Chinese Patent Office
Deloitte
Johnson and Johnson
Cantor Fitzgerald
Teva
McKinsey

Generated: December 17, 2017

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Guaifenesin - Generic Drug Details

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

Guaifenesin
is the generic ingredient in seven branded drugs marketed by Actavis Labs Fl, Guardian Pharms, Perrigo R And D, Reckitt Benckiser, Mission Pharmacal Co, and Sovereign Pharms, and is included in nine NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Guaifenesin has thirty-nine patent family members in nineteen countries.

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

Medical Subject Heading (MeSH) Categories for guaifenesin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Reckitt BenckiserMUCINEX Dguaifenesin; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021585-001Jun 22, 2004OTCYesNo► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEX Dguaifenesin; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021585-001Jun 22, 2004OTCYesNo► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEXguaifenesinTABLET, EXTENDED RELEASE;ORAL021282-001Jul 12, 2002OTCYesNo► Subscribe► SubscribeY► Subscribe
Mission Pharmacal CoFLOWTUSSguaifenesin; hydrocodone bitartrateSOLUTION;ORAL022424-001May 14, 2015RXNoNo► Subscribe► Subscribe► Subscribe
Reckitt BenckiserMUCINEXguaifenesinTABLET, EXTENDED RELEASE;ORAL021282-002Dec 18, 2002OTCYesYes► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEX Dguaifenesin; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021585-002Jun 22, 2004OTCYesYes► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEX Dguaifenesin; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021585-001Jun 22, 2004OTCYesNo► Subscribe► SubscribeY► Subscribe
Reckitt BenckiserMUCINEXguaifenesinTABLET, EXTENDED RELEASE;ORAL021282-002Dec 18, 2002OTCYesYes► Subscribe► Subscribe► Subscribe
Reckitt BenckiserMUCINEXguaifenesinTABLET, EXTENDED RELEASE;ORAL021282-002Dec 18, 2002OTCYesYes► Subscribe► SubscribeY► Subscribe
Guardian PharmsGUAIFENESINguaifenesinTABLET, EXTENDED RELEASE;ORAL209215-002Sep 6, 2017OTCNoNo► Subscribe► 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
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

Country Document Number Estimated Expiration
South Africa200409171► Subscribe
Taiwan200727919► Subscribe
MexicoPA04010225► Subscribe
Japan5466346► Subscribe
New Zealand561044► Subscribe
TaiwanI359034► Subscribe
Hong Kong1052651► Subscribe
Taiwan200733952► Subscribe
Spain2301537► Subscribe
Israel152012► 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 plans and pricing

Serving leading biopharmaceutical companies globally:

Healthtrust
Chinese Patent Office
Cantor Fitzgerald
QuintilesIMS
UBS
Mallinckrodt
Express Scripts
Baxter
Dow
Deloitte

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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