DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - Generic Drug Details

What are the generic drug sources for dextromethorphan hydrobromide; guaifenesin and what is the scope of patent protection?

Dextromethorphan hydrobromide; guaifenesin is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Perrigo R And D, Sun Pharm, and Rb Hlth, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Sixty-three suppliers are listed for this compound.

Summary for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	63
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
DailyMed Link:	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN at DailyMed

Pharmacology for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

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

Anatomical Therapeutic Chemical (ATC) Classes for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

R05CA	Expectorants
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

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 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

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
Dr Reddys	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	217340-001	Aug 1, 2023		OTC	No	No
Actavis Labs Fl	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	091070-001	Aug 31, 2015		OTC	No	No
Sun Pharm	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	214781-001	Jul 1, 2021		OTC	No	No
Sun Pharm	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	214781-002	Jul 1, 2021		OTC	No	No

Expired US Patents for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

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