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Last Updated: March 7, 2021

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Guaifenesin; pseudoephedrine hydrochloride - Generic Drug Details

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What are the generic 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 Labs Ltd, Sun Pharm Inds Inc, and Rb Hlth, and is included in five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Guaifenesin; pseudoephedrine hydrochloride has thirty-nine patent family members in nineteen countries.

There are twenty drug master file entries for guaifenesin; pseudoephedrine hydrochloride. Twenty-seven 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
Mantecorp Industria Quimica e Farmaceutica Ltd.Phase 3

See all guaifenesin; pseudoephedrine hydrochloride clinical trials

Paragraph IV (Patent) Challenges for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
MUCINEX D TABLET, EXTENDED RELEASE;ORAL guaifenesin; pseudoephedrine hydrochloride 021585 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
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 OTC Yes Yes   Start Trial   Start Trial Y   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
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
>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   Start Trial   Start Trial
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004   Start Trial   Start Trial
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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