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Guaifenesin - Generic Drug Details

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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 Ltd, Granules, Guardian Drug, Ohm Labs Inc, Perrigo R And D, Rb Hlth, Bkk Pharms, Sovereign Pharms, Eci Pharms Llc, Dr Reddys Labs Ltd, and Sun Pharm Inds Inc, and is included in seventeen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Guaifenesin has thirty-nine patent family members in nineteen countries.

There are twenty drug master file entries for guaifenesin. Forty-nine suppliers are listed for this compound.

Summary for guaifenesin

International Patents:	39
US Patents:	6
Tradenames:	8
Applicants:	13
NDAs:	17
Drug Master File Entries:	20
Suppliers / Packagers:	49
Bulk Api Vendors:	96
Clinical Trials:	29
Patent Applications:	6,339
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	N/A
Hoffmann-La Roche	N/A
Ache Laboratorios Farmaceuticos S.A.	Phase 3

See all guaifenesin clinical trials

Medical Subject Heading (MeSH) Categories for guaifenesin

Expectorants

Paragraph IV (Patent) Challenges for GUAIFENESIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
MUCINEX	TABLET, EXTENDED RELEASE;ORAL	guaifenesin	021282	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
Granules	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	213420-002	May 8, 2020		OTC	No	No
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004		OTC	Yes	No			Y
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474-001	Nov 14, 2014		DISCN	Yes	No			Y	Y
Perrigo R And D	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	078912-002	Nov 5, 2020		OTC	No	No
Amneal Pharms	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	207342-002	Jul 11, 2018		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	021282-002	Dec 18, 2002
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002

International Patents for guaifenesin

Country	Patent Number	Estimated Expiration
Canada	2405031
Portugal	1276467
Spain	2301537
Cyprus	1108166
Australia	2001255680