BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride and what is the scope of freedom to operate?

Brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride is the generic ingredient in four branded drugs marketed by Alpharma Us Pharms, Wockhardt, Wockhardt Bio Ag, Acella, Alkem Labs Ltd, Bionpharma, Chartwell Molecular, Dr Reddys Labs Sa, Padagis Us, Pharm Assoc, Rhodes Pharms, Taro, Wes Pharma Inc, and Robins Ah, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Eleven suppliers are listed for this compound.

Summary for BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	11
DailyMed Link:	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed

Pharmacology for BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Drug Class	Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists

US Patents and Regulatory Information for BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wes Pharma Inc	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	211170-001	Jun 16, 2020	AA	RX	No	No
Chartwell Molecular	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	213125-001	Apr 17, 2020	AA	RX	No	No
Robins Ah	DIMETANE-DX	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	019279-001	Aug 24, 1984		DISCN	Yes	No
Wockhardt	BROMFED-DM	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	089681-001	Dec 22, 1988		DISCN	No	No
Acella	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	203375-001	Sep 20, 2016	AA	RX	No	No