MUCINEX D Drug Patent 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.

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

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Summary for MUCINEX D

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	16
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
What excipients (inactive ingredients) are in MUCINEX D?	MUCINEX D excipients list
DailyMed Link:	MUCINEX D at DailyMed

Drug patent expirations by year for MUCINEX D

Recent Clinical Trials for MUCINEX D

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

Sponsor	Phase
Vitaccess Ltd	Phase 4
American Health Research	Phase 4
Massachusetts Eye and Ear Infirmary	N/A

See all MUCINEX D clinical trials

Pharmacology for MUCINEX D

Drug Class	alpha-Adrenergic Agonist Expectorant
Mechanism of Action	Adrenergic alpha-Agonists
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Paragraph IV (Patent) Challenges for MUCINEX D

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 MUCINEX D

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Glossary

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

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

International Patents for MUCINEX D

See the table below for patents covering MUCINEX D around the world.

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	007156	ЗАМЕДЛЕННО ВЫСВОБОЖДАЮЩИЕ ЛЕКАРСТВЕННЫЕ КОМПОЗИЦИИ ГВАЙФЕНЕЗИНА (SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS)	⤷ Sign Up
Mexico	PA04010225	LIBERACION SOSTENIDA DE LA COMBINACION DE GUAIFENESINA CON FARMACOS. (SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS.)	⤷ Sign Up
Portugal	1276467		⤷ Sign Up
Spain	2301537		⤷ Sign Up
Taiwan	200733952		⤷ Sign Up
Japan	2003531849		⤷ Sign Up
World Intellectual Property Organization (WIPO)	03088952		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration