GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Guaifenesin And Pseudoephedrine Hydrochloride, and what generic alternatives are available?

Guaifenesin And Pseudoephedrine Hydrochloride is a drug marketed by Actavis Labs Fl, Aurobindo Pharma Ltd, Dr Reddys, Granules, L Perrigo Co, and Sun Pharm Inds Inc. and is included in six NDAs.

The generic ingredient in GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Guaifenesin And Pseudoephedrine Hydrochloride

A generic version of GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE was approved as guaifenesin; pseudoephedrine hydrochloride by ACTAVIS LABS FL on May 27^th, 2015.

Summary for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents:	0
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	4
Patent Applications:	222
What excipients (inactive ingredients) are in GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE?	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE excipients list
DailyMed Link:	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

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

Sponsor	Phase
Dr. Reddy's Laboratories Limited	Phase 1
Reckitt Benckiser LLC	Phase 4
Reckitt Benckiser Inc.	Phase 4

See all GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Drug Class	Expectorant alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

US Patents and Regulatory Information for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Fl	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	091071-001	May 27, 2015		OTC	No	No
Granules	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216082-002	Aug 22, 2022		DISCN	No	No
Aurobindo Pharma Ltd	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	213203-001	Mar 25, 2020		OTC	No	No
Sun Pharm Inds Inc	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212542-001	Apr 28, 2020		OTC	No	No
Granules	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216082-001	Aug 22, 2022		DISCN	No	No
Actavis Labs Fl	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	091071-002	May 27, 2015		OTC	No	No
Aurobindo Pharma Ltd	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	213203-002	Mar 25, 2020		OTC	No	No