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.

Twelve 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:	12
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

Anatomical Therapeutic Chemical (ATC) Classes for BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

R06AB	Substituted alkylamines
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

R06AB	Substituted alkylamines
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Pharm Assoc	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	202940-001	Jul 21, 2014	AA	RX	No	No
Padagis Us	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	205292-001	Jul 15, 2014	AA	RX	No	Yes
Bionpharma	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride	SYRUP;ORAL	203997-001	Sep 30, 2020		DISCN	No	No