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Last Updated: May 24, 2024

Guaifenesin - Generic Drug Details


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What are the generic drug sources for guaifenesin and what is the scope of patent protection?

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. Eighty-two 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

Identify potential brand extensions & 505(b)(2) entrants

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

See all guaifenesin clinical trials

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
Marksans Pharma GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 217780-001 Aug 21, 2023 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 210453-001 Oct 21, 2019 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 213203-001 Mar 25, 2020 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 213203-002 Mar 25, 2020 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ohm Labs Inc GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 209254-001 Jul 16, 2018 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 ⤷  Sign Up ⤷  Sign Up
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 ⤷  Sign Up ⤷  Sign Up
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 ⤷  Sign Up ⤷  Sign Up
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 ⤷  Sign Up ⤷  Sign Up
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 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.