Guaifenesin; hydrocodone bitartrate - Generic Drug Details

What are the generic sources for guaifenesin; hydrocodone bitartrate and what is the scope of patent protection?

Guaifenesin; hydrocodone bitartrate is the generic ingredient in four branded drugs marketed by Chartwell Rx, Sovereign Pharms, and Eci Pharms Llc, and is included in four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for guaifenesin; hydrocodone bitartrate

US Patents:	3
Tradenames:	4
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	guaifenesin; hydrocodone bitartrate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for guaifenesin; hydrocodone bitartrate

Dosage:

SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for guaifenesin; hydrocodone bitartrate

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

Sponsor	Phase
Reckitt Benckiser LLC	Phase 1

See all guaifenesin; hydrocodone bitartrate clinical trials

Pharmacology for guaifenesin; hydrocodone bitartrate

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

US Patents and Regulatory Information for guaifenesin; hydrocodone bitartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	FLOWTUSS	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	022424-001	May 14, 2015		DISCN	No	No
Eci Pharms Llc	XTRELUS	guaifenesin; hydrocodone bitartrate	TABLET;ORAL	208085-001	Apr 25, 2018		DISCN	Yes	No
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474-001	Nov 14, 2014		DISCN	Yes	No			Y	Y
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474-001	Nov 14, 2014		DISCN	Yes	No			Y	Y
Chartwell Rx	HYCOFENIX	guaifenesin; hydrocodone bitartrate; pseudoephedrine hydrochloride	SOLUTION;ORAL	022279-001	May 14, 2015		DISCN	Yes	No
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474-001	Nov 14, 2014		DISCN	Yes	No			Y	Y