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Last Updated: January 23, 2020

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MUCINEX D Drug Profile

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When do Mucinex D patents expire, and when can generic versions of Mucinex D launch?

Mucinex D is a drug marketed by Rb Hlth and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-nine patent family members in nineteen countries.

The generic ingredient in MUCINEX D is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.

US ANDA Litigation and Generic Entry Outlook for Mucinex D

Mucinex D was eligible for patent challenges on December 31, 1968.

Annual sales in 2017 were $7mm indicating the motivation for generic entry.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for MUCINEX D
Drug Prices for MUCINEX D

See drug prices for MUCINEX D

Drug Sales Revenue Trends for MUCINEX D

See drug sales revenues for MUCINEX D

Recent Clinical Trials for MUCINEX D

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

SponsorPhase
Massachusetts Eye and Ear InfirmaryN/A
Dr. Reddy's Laboratories LimitedPhase 1
Reckitt Benckiser Inc.Phase 1

See all MUCINEX D clinical trials

Recent Litigation for MUCINEX D

Identify potential future generic entrants

District Court Litigation
Case NameDate
RECKITT BENCKISER LLC v. AMNEAL PHARMACEUTICALS LLC2015-03-26
Reckitt Benckiser LLC v. Aurobindo Pharma Limited2014-09-17
Adams Respiratory Therapeutics, Inc. v. Perrigo Company2007-10-02

See all MUCINEX D litigation

Paragraph IV (Patent) Challenges for MUCINEX D
Tradename Dosage Ingredient NDA Submissiondate
MUCINEX D TABLET, EXTENDED RELEASE;ORAL guaifenesin; pseudoephedrine hydrochloride 021585 2008-12-29

US Patents and Regulatory Information for MUCINEX D

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 DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 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
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes No   Start Trial   Start Trial Y   Start Trial
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 021585-002 Jun 22, 2004 OTC Yes Yes   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

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