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Last Updated: March 28, 2024

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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

Guaifenesin; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Aurobindo Pharma Ltd, Dr Reddys, Granules, L Perrigo Co, Sun Pharm Inds Inc, and Rb Hlth, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Thirty suppliers are listed for this compound.

Recent Clinical Trials for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

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

SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1
Reckitt Benckiser LLCPhase 4
Reckitt Benckiser Inc.Phase 4

See all GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MUCINEX D Extended-release Tablets guaifenesin; pseudoephedrine hydrochloride 600 mg/60 mg and 1200 mg/120 mg 021585 1 2008-12-29

US Patents and Regulatory Information for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 208369-001 Dec 29, 2017 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 213203-002 Mar 25, 2020 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Fl GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071-002 May 27, 2015 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 208369-002 Dec 29, 2017 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Granules GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 216082-001 Aug 22, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Granules GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 216082-002 Aug 22, 2022 DISCN 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; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
>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.