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Last Updated: November 22, 2024

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, 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

SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1
Reckitt Benckiser LLCPhase 4
Reckitt Benckiser Inc.Phase 4

See all guaifenesin; pseudoephedrine hydrochloride clinical trials

Pharmacology for guaifenesin; pseudoephedrine hydrochloride
Drug ClassExpectorant
alpha-Adrenergic Agonist
Mechanism of ActionAdrenergic alpha-Agonists
Physiological EffectDecreased 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

Glossary
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 212542-002 Apr 28, 2020 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 213203-001 Mar 25, 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
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
Dr Reddys GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 208369-001 Dec 29, 2017 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Labs Fl GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071-002 May 27, 2015 OTC 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

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Expired US Patents for guaifenesin; pseudoephedrine hydrochloride

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 ⤷  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 021585-001 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
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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