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Last Updated: March 18, 2024

Guaifenesin - Generic Drug Details


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

Guaifenesin is the generic ingredient in eight branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Granules, Guardian Drug, Marksans Pharma, Ohm Labs Inc, Perrigo R And D, Rb Hlth, Chartwell Rx, Sovereign Pharms, Eci Pharms Llc, Aurobindo Pharma Ltd, L Perrigo Co, and Sun Pharm Inds Inc, and is included in twenty-one NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for guaifenesin

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Drug Sales Revenue Trends for guaifenesin

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Recent Clinical Trials for guaifenesin

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SponsorPhase
Johnson & Johnson Consumer and Personal Products WorldwidePhase 1
Hoffmann-La Roche
Massachusetts Eye and Ear InfirmaryN/A

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Pharmacology for guaifenesin
Medical Subject Heading (MeSH) Categories for guaifenesin
Paragraph IV (Patent) Challenges for GUAIFENESIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MUCINEX Extended-release Tablets guaifenesin 600 mg and 1.2 gm 021282 1 2006-06-09

US Patents and Regulatory Information for guaifenesin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo R And D GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 078912-001 Nov 23, 2011 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sovereign Pharms OBREDON guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 205474-001 Nov 14, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Guardian Drug GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 209215-001 Sep 6, 2017 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for guaifenesin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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