GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug 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, Granules, L Perrigo Co, Sun Pharm Inds Inc, and Rb Hlth, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Thirty suppliers are listed for this compound.

Summary for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	30
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
Reckitt Benckiser Inc.	Phase 4

See all GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Drug Class	Expectorant alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Anatomical Therapeutic Chemical (ATC) Classes for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MUCINEX D	Extended-release Tablets	guaifenesin; pseudoephedrine hydrochloride	600 mg/60 mg and 1200 mg/120 mg	021585	1	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	021585-001	Jun 22, 2004		OTC	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
L Perrigo Co	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	214407-002	Feb 1, 2022		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Inc	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212542-002	Apr 28, 2020		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Granules	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216082-001	Aug 22, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	021585-001	Jun 22, 2004	⤷ Sign Up	⤷ Sign Up
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004	⤷ Sign Up	⤷ Sign Up
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004	⤷ Sign Up	⤷ Sign Up
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004	⤷ Sign Up	⤷ Sign Up
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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