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Last Updated: March 4, 2021

DrugPatentWatch Database Preview

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 Ltd, Granules, Guardian Drug, Ohm Labs Inc, Perrigo R And D, Rb Hlth, Bkk Pharms, Sovereign Pharms, Eci Pharms Llc, Dr Reddys Labs Ltd, and Sun Pharm Inds Inc, and is included in seventeen NDAs. There are six 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.

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 WorldwideN/A
Hoffmann-La RocheN/A
Ache Laboratorios Farmaceuticos S.A.Phase 3

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Medical Subject Heading (MeSH) Categories for guaifenesin
Paragraph IV (Patent) Challenges for GUAIFENESIN
Tradename Dosage Ingredient NDA Submissiondate
MUCINEX TABLET, EXTENDED RELEASE;ORAL guaifenesin 021282 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
Granules GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 213420-002 May 8, 2020 OTC No No   Start Trial   Start Trial   Start Trial
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 OTC Yes No   Start Trial   Start Trial Y   Start Trial
Sovereign Pharms OBREDON guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 205474-001 Nov 14, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Perrigo R And D GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 078912-002 Nov 5, 2020 OTC No No   Start Trial   Start Trial   Start Trial
Amneal Pharms GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 207342-002 Jul 11, 2018 OTC No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002   Start Trial   Start Trial
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002   Start Trial   Start Trial
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002   Start Trial   Start Trial
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Express Scripts
Boehringer Ingelheim
Medtronic
Johnson and Johnson

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