Viewing data from:

MUCINEX

NDA

GUAIFENESIN | N021282 | RB HEALTH US LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Reckitt Benckiser Group PLC - Citizen Petition FDA-2009-P-0334 · 3 docket documents Reckitt Benckiser Group plc filed this citizen petition under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require any Abbreviated New Drug Application referencing Mucinex, Maximum Strength Mucinex, Mucinex D, or Mucinex DM modified-release guaifenes	505(q)	2009-07-19	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

25 trials from ClinicalTrials.gov, 22 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study NCT01364467	Phase 2	Completed	Virginia Commonwealth University	30	2011-05 → 2018-03-05
Mucinex Exploratory Cold Study NCT01046136	Phase 2	Completed	Reckitt Benckiser Inc.	378	2009-12
Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study NCT02572375	Phase 1	Completed	Nexgen Pharma, Inc	38	2014-10 → 2015-01
Treatment of Acute Sinusitis NCT00377403	Phase 4	Completed	Washington University School of Medicine	172	2006-10 → 2010-08
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI NCT01202279	Phase 4	Completed	Reckitt Benckiser Inc.	1,179	2009-10 → 2010-07
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections NCT01537081	Phase 2/3	Completed	Reckitt Benckiser LLC	2,810	2011-09 → 2012-07
Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Syrup in Patients Suffering a Upper Respiratory Tract Infection (URTI)NCT01576809	Phase 3	Completed	Novartis	51	2012-03 → 2012-05
Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h NCT03642262	Phase 1	Completed	Reckitt Benckiser Inc.	30	2013-06-02 → 2013-08-09
Study to Evaluate Drug-drug Interactions of Guaifenesin and Hydrocodone Bitartrate NCT03642873	Phase 1	Completed	Reckitt Benckiser LLC	24	2007-05-05 → 2007-05-21
Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections NCT01062256	N/A	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	265	2010-01 → 2010-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (6 FSS)

Lowest Price

$4.81

Highest Price

$92.57

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
63824-0008-15MUCINEX 600MG ER TAB	$18.51	FSS	RB Health (US) LLC	06/14/2027
63824-0008-32MUCINEX 600MG ER TAB	$4.81	FSS	RB Health (US) LLC	06/14/2027
63824-0008-34MUCINEX 600MG ER TAB	$8.71	FSS	RB Health (US) LLC	06/14/2027
63824-0008-50MUCINEX 600MG ER TAB	$92.57	FSS	RB Health (US) LLC	06/14/2027
63824-0023-35MAX STRENGTH MUCINEX TAB	$7.82	FSS	RB Health (US) LLC	06/14/2027
63824-0023-36MAX STRENGTH MUCINEX TAB	$14.50	FSS	RB Health (US) LLC	06/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain5 active DMFs13 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

DELTA SYNTHETIC CO LTDGUAIFENESIN

DMF 58091985

SYNTHOKEM LABS PRIVATE LTDGUAIFENESIN USP

DMF 104131993

GRANULES INDIA LTDGUAIFENESIN USP

DMF 143721999

SEVEN STAR PHARMACEUTICAL CO LTDGUAIFENESIN USP

DMF 161222002

ZHEJIANG HAIZHOU PHARMACEUTICAL CO LTDGUAIFENESIN

DMF 291792015

GANES CHEMICALS INC PENNSVILLE DIVInactiveGUAIFENESIN GLYCERYLGUAIACOLATE

DMF 25021975

PEBOC LTDInactiveGUAIFENESIN USP

DMF 48661983

RHODIA OPERATIONSInactiveGUAIFENESIN (GLYCEROL GUAIACOLATE)

DMF 49891983

CHINA NATIONAL CHEMICAL IMPORT AND EXPORT CORPInactiveGUAIFENESIN USP

DMF 54231984

BOEHRINGER INGELHEIM CHEMICALS INCInactiveGUAIFENESIN

DMF 59721985

CHEMSPEC CHEMICALS PVT LTDInactiveGUAIFENESIN

DMF 92621991

SIANG TA PHARMACEUTICAL CO LTDInactiveGUAIFENESIN

DMF 109881994

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveGUAIFENESIN USP

DMF 142341999

BOEHRINGER INGELHEIM CHEMICALS INCInactiveGUAIFENESIN USP

DMF 155072001

NINGBO SMART PHARMACEUTICAL CO LTDInactiveGUAIFENESIN USP

DMF 180292005

ZHEJIANG JIANFENG HAIZHOU PHARMACEUTICAL CO LTDInactiveGUAIFENESIN

DMF 228402009

PAN DRUGS LTDInactiveGUAIFENESIN USP

DMF 257522012

PAN DRUGS LTDInactiveGUAIFENESIN USP (NEW ROUTE)

DMF 263242012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Sep 3, 2024	SUPPL -55	View Letter (PDF)
Feb 23, 2021	SUPPL -54	View Letter (PDF)
Aug 13, 2020	SUPPL -51	View Letter (PDF)
Sep 30, 2019	SUPPL -44	View Letter (PDF)
Sep 30, 2019	SUPPL -46	View Letter (PDF)
Sep 30, 2019	SUPPL -45	View Letter (PDF)
Sep 30, 2019	SUPPL -31	View Letter (PDF)
Sep 30, 2019	SUPPL -43	View Letter (PDF)
Jul 6, 2017	SUPPL -48	View Letter (PDF)
Mar 7, 2014	SUPPL -37	View Letter (PDF)
Mar 7, 2014	SUPPL -35	View Letter (PDF)
Apr 7, 2009	SUPPL -29	View Letter (PDF)
Aug 22, 2008	SUPPL -25	View Letter (PDF)
Sep 7, 2007	SUPPL -21	View Letter (PDF)
Nov 22, 2006	SUPPL -16	View Letter (PDF)
Sep 18, 2006	SUPPL -11	View Letter (PDF)
Dec 18, 2002	SUPPL -1	View Letter (PDF)
Jul 12, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 600MG

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 12, 2002

No patent or exclusivity listings for this strength.

#002 — 1.2GM

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 18, 2002