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Last Updated: November 29, 2022

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, Ohm Labs Inc, Perrigo R And D, Rb Hlth, Bkk Pharms, Sovereign Pharms, Eci Pharms Llc, Aurobindo Pharma Ltd, L Perrigo Co, and Sun Pharm Inds Inc, and is included in twenty 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. Sixty-six 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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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
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sovereign Pharms OBREDON guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 205474-001 Nov 14, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Actavis Labs Fl GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 091009-002 Sep 3, 2015 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 208369-001 Dec 29, 2017 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 See Plans and Pricing See Plans and Pricing
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 See Plans and Pricing See Plans and Pricing
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 See Plans and Pricing See Plans and Pricing
>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

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 verification 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.