MUCINEX DM Drug Patent Profile

Which patents cover Mucinex Dm, and when can generic versions of Mucinex Dm launch?

Mucinex Dm is a drug marketed by Rb Hlth and is included in one NDA.

The generic ingredient in MUCINEX DM 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.

Summary for MUCINEX DM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	16
Drug Prices:	Drug price information for MUCINEX DM
Drug Sales Revenues:	Drug sales revenues for MUCINEX DM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MUCINEX DM
What excipients (inactive ingredients) are in MUCINEX DM?	MUCINEX DM excipients list
DailyMed Link:	MUCINEX DM at DailyMed

See drug prices for MUCINEX DM

See drug sales revenues for MUCINEX DM

Recent Clinical Trials for MUCINEX DM

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 DM clinical trials

Pharmacology for MUCINEX DM

Drug Class	Expectorant Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Paragraph IV (Patent) Challenges for MUCINEX DM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MUCINEX DM	Extended-release Tablets	dextromethorphan hydrobromide; guaifenesin	600 mg/30 mg and 1200 mg/60 mg	021620	1	2008-12-17

US Patents and Regulatory Information for MUCINEX DM

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 DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004		OTC	Yes	No
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004		OTC	Yes	Yes

Expired US Patents for MUCINEX DM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004

International Patents for MUCINEX DM

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	200401369
Canada	2405031	FORMULATION ET COMPRIMES DE LIBERATION SOUTENUE DE GUAIFENESINE (GUAIFENESIN SUSTAINED RELEASE FORMULATION AND TABLETS)
Australia	2001255680
Hong Kong	1052651
Eurasian Patent Organization	007156	ЗАМЕДЛЕННО ВЫСВОБОЖДАЮЩИЕ ЛЕКАРСТВЕННЫЕ КОМПОЗИЦИИ ГВАЙФЕНЕЗИНА (SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS)
Australia	2003237807
China	1655766

Supplementary Protection Certificates for MUCINEX DM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	60/2013	Austria		PRODUCT NAME: KOMBINATION VON A) DEXTROMETHORPHAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE DEXTROMETHORPHANHYDROBROMID, UND INSBESONDERE DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT UND B) CHINIDIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE CHINIDINSULFAT, UND INSBESONDERE CHINIDINSULFATDIHYDRAT.; REGISTRATION NO/DATE: EU/1/13/833 20130626
1539166	CA 2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1539166	92323	Luxembourg		PRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624
1539166	2013C/064	Belgium		PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
1539166	CR 2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1539166	13C0062	France		PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
1539166	122013000090	Germany		PRODUCT NAME: KOMBINATION AUS: (A) DEXTROMETHORPHAN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ, Z.B. DEXTROMETHORPHAN-HYDROBROMID UND INSBESONDERE DEXTROMETHORPHAN-HYDROBROMID-MONOHYDRAT; UND (B) CHINIDIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, Z.B.CHINIDIN-SULFAT UND INSBESONDERE CHINIDIN-SULFAT-DIHYDRAT; REGISTRATION NO/DATE: EU/1/13/833 20130624