Question 1

Is there a generic for Guaifenesin; hydrocodone bitartrate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Guaifenesin; hydrocodone bitartrate. It is available as 3 brand (NDA) applications.

Question 2

What is the reference-listed drug for Guaifenesin; hydrocodone bitartrate?

Accepted Answer

XTRELUS (NDA 208085, ECI PHARMS LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Guaifenesin; hydrocodone bitartrate?

Accepted Answer

The Orange Book lists 3 patents against Guaifenesin; hydrocodone bitartrate products, with the earliest listed expiry in 2035. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Guaifenesin; hydrocodone bitartrate are approved?

Accepted Answer

Guaifenesin; hydrocodone bitartrate is approved in the following dosage forms: solution, tablet.

Product	Applicant	Application	TE	Approved
XTRELUSRLD	ECI PHARMS LLC	NDA 208085	—	Apr 25, 2018
OBREDONRLD	SOVEREIGN PHARMS	NDA 205474	—	Nov 14, 2014
FLOWTUSS	CHARTWELL RX	NDA 022424	—	May 14, 2015

Patent	Expires	In	Type
9549907	Nov 13, 2035	in 9 yr 6 mo	SubstanceProductU-2023
9808431	Nov 13, 2035	in 9 yr 6 mo	SubstanceProductU-2023
10105324	Nov 13, 2035	in 9 yr 6 mo	SubstanceProductU-2023

Guaifenesin; hydrocodone bitartrate

Brand (NDA) products · solution, tablet

Listed patents (3)

Guaifenesin; hydrocodone bitartrate — frequently asked questions

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