Guaifenesin; pseudoephedrine hydrochloride - Generic Drug Details

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

Guaifenesin; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Sun Pharm Inds Inc, and Rb Hlth, and is included in five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are twenty drug master file entries for guaifenesin; pseudoephedrine hydrochloride. Twenty-seven suppliers are listed for this compound.

Summary for guaifenesin; pseudoephedrine hydrochloride

International Patents:	39
US Patents:	3
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	20
Suppliers / Packagers:	27
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for guaifenesin; pseudoephedrine hydrochloride
DailyMed Link:	guaifenesin; pseudoephedrine hydrochloride at DailyMed

Recent Clinical Trials for guaifenesin; pseudoephedrine hydrochloride

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

Sponsor	Phase
Dr. Reddy's Laboratories Limited	Phase 1
Reckitt Benckiser LLC	Phase 4
Mantecorp Industria Quimica e Farmaceutica Ltd.	Phase 3

See all guaifenesin; pseudoephedrine hydrochloride clinical trials

Paragraph IV (Patent) Challenges for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
MUCINEX D	TABLET, EXTENDED RELEASE;ORAL	guaifenesin; pseudoephedrine hydrochloride	021585	2008-12-29

US Patents and Regulatory Information for guaifenesin; pseudoephedrine hydrochloride

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Glossary

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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 D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004		OTC	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004		OTC	Yes	No	Start Trial	Start Trial	Y			Start Trial
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004		OTC	Yes	No	Start Trial	Start Trial	Y			Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for guaifenesin; pseudoephedrine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004	Start Trial	Start Trial
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004	Start Trial	Start Trial
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for guaifenesin; pseudoephedrine hydrochloride

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Country	Patent Number	Estimated Expiration
Hong Kong	1052651	Start Trial
China	1655766	Start Trial
Spain	2301537	Start Trial
>Country	>Patent Number	>Estimated Expiration

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