Guaifenesin - Generic Drug Details

What are the generic sources for guaifenesin and what is the scope of freedom to operate?

Guaifenesin is the generic ingredient in eight branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Granules, Guardian Drug, Ohm Labs Inc, Perrigo R And D, Rb Hlth, Bkk Pharms, Sovereign Pharms, Eci Pharms Llc, Aurobindo Pharma Ltd, L Perrigo Co, and Sun Pharm Inds Inc, and is included in twenty NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for guaifenesin. Sixty-six suppliers are listed for this compound.

Summary for guaifenesin

US Patents:	3
Tradenames:	8
Applicants:	15
NDAs:	20
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	66
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	31
Patent Applications:	6,428
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends 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

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
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002		OTC	Yes	Yes
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474-001	Nov 14, 2014		DISCN	Yes	No			Y	Y
Actavis Labs Fl	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	091009-002	Sep 3, 2015		OTC	No	No
Dr Reddys	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208369-001	Dec 29, 2017		OTC	No	No

Expired US Patents for guaifenesin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002