GUAIFENESIN Drug Patent Profile

Which patents cover Guaifenesin, and when can generic versions of Guaifenesin launch?

Guaifenesin is a drug marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Granules, Guardian Drug, Marksans Pharma, Ohm Labs Inc, Perrigo R And D, Sun Pharm, Aurobindo Pharma Ltd, L Perrigo Co, and Sun Pharm Inds Inc. and is included in twenty-one NDAs.

The generic ingredient in GUAIFENESIN 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

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

Summary for GUAIFENESIN

US Patents:	0
Applicants:	13
NDAs:	21
Finished Product Suppliers / Packagers:	79
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	31
Patent Applications:	3,062
Drug Prices:	Drug price information for GUAIFENESIN
Drug Sales Revenues:	Drug sales revenues for GUAIFENESIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GUAIFENESIN
What excipients (inactive ingredients) are in GUAIFENESIN?	GUAIFENESIN excipients list
DailyMed Link:	GUAIFENESIN at DailyMed

See drug prices for GUAIFENESIN

See drug sales revenues for GUAIFENESIN

Recent Clinical Trials for GUAIFENESIN

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

Sponsor	Phase
Johnson & Johnson Consumer and Personal Products Worldwide	Phase 1
Hoffmann-La Roche
Massachusetts Eye and Ear Infirmary	N/A

See all GUAIFENESIN clinical trials

Pharmacology for GUAIFENESIN

Drug Class	Expectorant
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Medical Subject Heading (MeSH) Categories for GUAIFENESIN

Expectorants

Anatomical Therapeutic Chemical (ATC) Classes for GUAIFENESIN

R05CA	Expectorants
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for GUAIFENESIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MUCINEX	Extended-release Tablets	guaifenesin	600 mg and 1.2 gm	021282	1	2006-06-09

US Patents and Regulatory Information for GUAIFENESIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212542-001	Apr 28, 2020		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
Sun Pharm	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	214781-001	Jul 1, 2021		OTC	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	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	214781-002	Jul 1, 2021		OTC	No	No
Actavis Labs Fl	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	091009-002	Sep 3, 2015		OTC	No	No
Actavis Labs Fl	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	091070-001	Aug 31, 2015		OTC	No	No