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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-three 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

Annual sales in 2018 were $5mm indicating the motivation for generic entry (peak sales were $7mm in 2017).

There have been four 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

Summary for MUCINEX D

International Patents:	39
US Patents:	3
Applicants:	1
NDAs:	2
Suppliers / Packagers:	6
Clinical Trials:	15
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MUCINEX D
Drug Sales Revenues:	Drug sales revenues for MUCINEX D
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MUCINEX D
DailyMed Link:	MUCINEX D at DailyMed

See drug prices for MUCINEX D

See drug sales revenues for MUCINEX D

Recent Clinical Trials for MUCINEX D

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

Sponsor	Phase
Massachusetts Eye and Ear Infirmary	N/A
Dr. Reddy's Laboratories Limited	Phase 1
Reckitt Benckiser Inc.	Phase 1

See all MUCINEX D clinical trials

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

Expired US Patents for MUCINEX D

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
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004

International Patents for MUCINEX D

Country	Patent Number	Estimated Expiration
Denmark	1276467
China	1655766
Canada	2405031
European Patent Office	1503739