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Last Updated: July 23, 2021

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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 patent protection?

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

See all guaifenesin clinical trials

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
Perrigo R And D GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 078912-001 Nov 23, 2011 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharm Inds Inc GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 212542-001 Apr 28, 2020 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sovereign Pharms OBREDON guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 205474-001 Nov 14, 2014 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>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 021282-001 Jul 12, 2002 ⤷  Try it Free ⤷  Try it Free
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 ⤷  Try it Free ⤷  Try it Free
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
Merck
McKinsey
Harvard Business School
Colorcon

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.