Pseudoephedrine hydrochloride - Generic Drug Details

What are the generic drug 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, Fosun Pharma, 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 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:	30
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	69
Patent Applications:	2,321
Formulation / Manufacturing:	see details
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

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
Watson Labs	TRIPROLIDINE AND PSEUDOEPHEDRINE	pseudoephedrine hydrochloride; triprolidine hydrochloride	TABLET;ORAL	088318-002	Jan 13, 1984		DISCN	No	No
Cenci	ACTAHIST	pseudoephedrine hydrochloride; triprolidine hydrochloride	SYRUP;ORAL	088344-001	Feb 9, 1984		DISCN	No	No
Kv Pharm	TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES	pseudoephedrine hydrochloride; triprolidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	072758-001	Nov 25, 1991		DISCN	No	No
Glaxosmithkline	ACTIFED	pseudoephedrine hydrochloride; triprolidine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018996-001	Jun 17, 1985		DISCN	No	No
Newtron Pharms	TRILITRON	pseudoephedrine hydrochloride; triprolidine hydrochloride	SYRUP;ORAL	088474-001	Feb 12, 1985		DISCN	No	No
Kv Pharm	TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES	pseudoephedrine hydrochloride; triprolidine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	071798-001	Mar 16, 1989		DISCN	No	No
Cenci	HISTAFED	pseudoephedrine hydrochloride; triprolidine hydrochloride	SYRUP;ORAL	088283-001	Apr 20, 1984		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