DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE - Generic Drug Details

What are the generic drug sources for dexbrompheniramine maleate; pseudoephedrine sulfate and what is the scope of patent protection?

Dexbrompheniramine maleate; pseudoephedrine sulfate is the generic ingredient in six branded drugs marketed by Copley Pharm, Avanthi Inc, Sandoz, Schering Plough, Pioneer Pharms, and Schering, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

US Patents:	0
Tradenames:	6
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	1
DailyMed Link:	DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE at DailyMed

Pharmacology for DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

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

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

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 DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering Plough	DISOPHROL	dexbrompheniramine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	013483-004	Sep 13, 1982		DISCN	No	No
Pioneer Pharms	RESPORAL	dexbrompheniramine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	089139-001	Jun 16, 1988		DISCN	No	No
Avanthi Inc	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	dexbrompheniramine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	078648-001	Feb 27, 2013		DISCN	No	No
Sandoz	DISOBROM	dexbrompheniramine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	070770-001	Sep 30, 1991		DISCN	No	No
Copley Pharm	BROMPHERIL	dexbrompheniramine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	089116-001	Jan 22, 1987		DISCN	No	No
Schering	DISOPHROL	dexbrompheniramine maleate; pseudoephedrine sulfate	TABLET;ORAL	012394-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Schering Plough	DRIXORAL	dexbrompheniramine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	013483-003	Sep 13, 1982		DISCN	Yes	No