PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for pseudoephedrine hydrochloride and what is the scope of patent protection?

Pseudoephedrine hydrochloride is the generic ingredient in sixteen branded drugs marketed by Sanofi Aventis Us, Glaxosmithkline, Aurobindo Pharma, L Perrigo Co, Sun Pharm Inds Ltd, Mcneil Cons, J And J Consumer Inc, Kv Pharm, Cenci, Usl Pharma, Newtron Pharms, Pvt Form, Chartwell Rx, Sandoz, Teva, Watson Labs, West Ward, Ivax Sub Teva Pharms, and Superpharm, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for pseudoephedrine hydrochloride. Thirty-two suppliers are listed for this compound.

Summary for PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents:	0
Tradenames:	16
Applicants:	19
NDAs:	23
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	69
Patent Applications:	2,321
What excipients (inactive ingredients) are in PSEUDOEPHEDRINE HYDROCHLORIDE?	PSEUDOEPHEDRINE HYDROCHLORIDE excipients list
DailyMed Link:	PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed

See drug sales revenues for PSEUDOEPHEDRINE HYDROCHLORIDE

Recent Clinical Trials for PSEUDOEPHEDRINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
John Muir Health	N/A
University of Maryland, Baltimore	Phase 4

See all PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for PSEUDOEPHEDRINE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for PSEUDOEPHEDRINE HYDROCHLORIDE

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

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

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

US Patents and Regulatory Information for PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cenci	HISTAFED	pseudoephedrine hydrochloride; triprolidine hydrochloride	SYRUP;ORAL	088283-001	Apr 20, 1984		DISCN	No	No
Sandoz	PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE	pseudoephedrine hydrochloride; triprolidine hydrochloride	TABLET;ORAL	088193-001	May 17, 1983		DISCN	No	No
Newtron Pharms	TRILITRON	pseudoephedrine hydrochloride; triprolidine hydrochloride	TABLET;ORAL	088515-001	Jan 9, 1985		DISCN	No	No
L Perrigo Co	PSEUDOEPHEDRINE HYDROCHLORIDE	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	075153-001	Feb 26, 1999		OTC	No	Yes
Chartwell Rx	CORPHED	pseudoephedrine hydrochloride; triprolidine hydrochloride	TABLET;ORAL	088602-001	Apr 11, 1985		DISCN	No	No
Newtron Pharms	TRILITRON	pseudoephedrine hydrochloride; triprolidine hydrochloride	SYRUP;ORAL	088474-001	Feb 12, 1985		DISCN	No	No

Expired US Patents for PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992