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Last Updated: August 11, 2020

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MUCINEX Drug Profile

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

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

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

The generic ingredient in MUCINEX is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Fifty-four 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

Annual sales in 2018 were $18mm indicating the motivation for generic entry (peak sales were $27mm in 2007).

There have been three 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
Drug Prices for MUCINEX

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Drug Sales Revenue Trends for MUCINEX

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Recent Clinical Trials for MUCINEX

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 clinical trials

Paragraph IV (Patent) Challenges for MUCINEX
Tradename Dosage Ingredient NDA Submissiondate
MUCINEX TABLET, EXTENDED RELEASE;ORAL guaifenesin 021282 2006-06-09

US Patents and Regulatory Information for MUCINEX

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 guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 OTC Yes Yes   Start Trial   Start Trial   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 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 guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 OTC Yes No   Start Trial   Start Trial   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 021585-002 Jun 22, 2004 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Rb Hlth MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 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

Expired US Patents for MUCINEX

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   Start Trial   Start Trial
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002   Start Trial   Start Trial
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002   Start Trial   Start Trial
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002   Start Trial   Start Trial
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002   Start Trial   Start Trial
Rb Hlth MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
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Merck
Harvard Business School
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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.