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Last Updated: December 12, 2019

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GUAIFENESIN Drug Profile

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Which patents cover Guaifenesin, and what generic alternatives are available?

Guaifenesin is a drug marketed by Actavis Labs Fl, Amneal Pharms, Guardian Drug, Ohm Labs Inc, Perrigo R And D, Aurobindo Pharma Ltd, and Dr Reddys Labs Ltd. and is included in eleven NDAs.

The generic ingredient in GUAIFENESIN is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.

Drug patent expirations by year for GUAIFENESIN
Drug Prices for GUAIFENESIN

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Drug Sales Revenue Trends for GUAIFENESIN

See drug sales revenues for GUAIFENESIN

Recent Clinical Trials for GUAIFENESIN

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

SponsorPhase
Johnson & Johnson Consumer and Personal Products WorldwideN/A
Hoffmann-La RocheN/A
Ache Laboratorios Farmaceuticos S.A.Phase 3

See all GUAIFENESIN clinical trials

Recent Litigation for GUAIFENESIN

Identify potential future generic entrants

District Court Litigation
Case NameDate
RECKITT BENCKISER LLC v. AMNEAL PHARMACEUTICALS LLC2015-03-26
Reckitt Benckiser LLC v. Aurobindo Pharma Limited2014-09-17
Adams Respiratory Therapeutics, Inc. v. Perrigo Company2007-10-02

See all GUAIFENESIN litigation

Medical Subject Heading (MeSH) Categories for GUAIFENESIN
Synonyms for GUAIFENESIN
.alpha.-Glyceryl guaiacol ether
.alpha.-Glyceryl guaiacolate ether
(+-)-3-(o-Methoxyphenoxy)-1,2-propanediol
(2R)-3-(2-methoxyphenoxy)propane-1,2-diol
(component of) Deconsal II
1, 3-(2-methoxyphenoxy)-
1, 3-(o-methoxyphenoxy)-
1,2-Dihydroxy-3-(2-methoxyphenoxy)propane
1,2-Propanediol, 3-(2-methoxyphenoxy)-
1,2-Propanediol, 3-(2-methoxyphenoxy)- (+-)-
1,2-Propanediol, 3-(o-methoxyphenoxy)-
1,2,3-Propanetriol, ether with 2-methoxyphenol
1,3-Propanetriol, ether with 2-methoxyphenol
12041-73-5
128707-44-8
1336-67-0
2-G
2/G
3 - (2 - Methoxyphenoxy) - 1, 2 - propanediol
3-(2-Methoxy-phenoxy)-propane-1,2-diol
3-(2-Methoxyphenoxy)-1, 2-propanediol
3-(2-Methoxyphenoxy)-1,2-propanediol
3-(2-Methoxyphenoxy)-1,2-propanediol, 99+%
3-(2-methoxyphenoxy)propane-1,2-diol
3-(o-Methoxyphenoxy)-1,2-propanediol
3-(o-Methoxyphenoxy)-propanediol-1,2
3-[o-Methoxyphenoxy]-1,2-propanediol
3-{[2-(methyloxy)phenyl]oxy}propane-1,2-diol
3-o-Methoxyphenoxypropane 1:2-diol
4-06-00-05576 (Beilstein Handbook Reference)
93-14-1
a-Glyceryl guaiacol ether
a-Glyceryl guaiacolate ether
AB00052006
AB00052006_12
AB00052006_13
AB00052006-10
AB00052006-11
AB2000264
AC-26819
AC1L1G42
AC1Q4765
ACN-046918
Actifed C
Actifed-C
Aeronesin
Aether glycerinoguaiacolicus
AI3-24947
AK402920
AKOS005435152
alpha-Glyceryl guaiacol ether
alpha-Glyceryl guaiacolate ether
Amonidren
Amonidrin
AN-24254
Anti-Tuss
ANW-43892
API0000027
Aresol
Balminil Expectorant
BBL009981
Benylin-E
BPBio1_000938
BRD-A90515964-001-05-8
BRD-A90515964-001-09-0
Breonesin
Brexin EX (Salt/Mix)
BRN 2049375
Bronchol
Brondecon (Salt/Mix)
Bronkaid Caplets (Salt/Mix)
BSPBio_000852
BSPBio_002088
C10H14O4
Calmipan
Calmylin Expectorant
CAS-93-14-1
CCG-39687
CHEBI:5551
CHEMBL980
Colrex expectorant
component of Brondecon
component of Colrex Expectorant
component of Hycotuss
component of Quibron
component of Quibron Plus
Congestac (Salt/Mix)
Contac Cough Formula (Salt/Mix)
Cortussin
Creson
CS-2251
CTK3J2493
D00337
DB00874
Diabetic Tussin EX
Dilor G (Salt/Mix)
Dilyn
Dimacol (Salt/Mix)
DivK1c_000248
Dorassin
DSSTox_CID_3114
DSSTox_GSID_23114
DSSTox_RID_76881
DTXSID5023114
EINECS 202-222-5
Entex (Salt/Mix)
Equicol
Fenesin
Flartussin
FT-0613565
G 87
G0159
Gaiamar
Gee-Gee
Genatuss
GGE
Glyc
glycerin ether
Glycerin guaiacolate
Glycerin monoguaiacol ether
Glycerinmonoguaiacol ether
Glycero-guaiacol ether
Glycerol .alpha.-(2-methoxyphenyl) ether
Glycerol .alpha.-(o-methoxyphenyl)ether
Glycerol .alpha.-guaiacyl ether
Glycerol .alpha.-guiacyl ether
Glycerol .alpha.-monoguaiacol ether
Glycerol a-(2-methoxyphenyl) ether
Glycerol a-(o-methoxyphenyl)ether
Glycerol a-guaiacyl ether
Glycerol a-guiacyl ether
Glycerol a-monoguaiacol ether
Glycerol alpha-(2-methoxyphenyl) ether
Glycerol alpha-(o-methoxyphenyl) ether
Glycerol alpha-(o-methoxyphenyl)ether
Glycerol alpha-guaiacyl ether
Glycerol alpha-guiacyl ether
Glycerol alpha-monoguaiacol ether
Glycerol guaiacolate
Glycerol mono(2-methoxyphenyl) ether
Glycerol mono(2-methoxyphenyl)ether
Glycerol-.alpha.-guajakolether
Glycerol-a-guajakolether
Glycerol-alpha-guajakolether
Glycerol-alpha-guajakolether [Czech]
Glycerol-alpha-monoguaiacol ether
Glycerol, 1-(2-methoxyphenyl) ether
Glyceryl guaiacol
Glyceryl guaiacol ether
GLYCERYL GUAIACOLATE
Glyceryl guaiacolate ether
Glyceryl guaiacyl ether
Glyceryl guaicolate
Glyceryl guiacolate
Glycerylguaiacol
Glycodex
Glycotuss
Glytuss
Gnaifenesin
GTPL7617
Guaia-rom
Guaiacol glycerin ether
Guaiacol glycerol ether
Guaiacol glyceryl ether
Guaiacol glyceryl ether, >=98% (GC)
Guaiacolglicerinetere
Guaiacolic acid, ester with glycerol
Guaiacuran
Guaiacurane
Guaiacyl glyceryl ether
Guaiamar
Guaianesin
Guaicol glycerine ether
Guaicol glyceryl ether
Guaifenesin (Guaiphenesin)
Guaifenesin (JP17/USP/INN)
Guaifenesin [USAN:INN:JAN]
Guaifenesin [USAN:USP:INN:BAN:JAN]
Guaifenesin Dc 95%
Guaifenesin for peak identification, European Pharmacopoeia (EP) Reference Standard
Guaifenesin-d3
Guaifenesin, European Pharmacopoeia (EP) Reference Standard
Guaifenesin, Pharmaceutical Secondary Standard; Certified Reference Material
Guaifenesin, United States Pharmacopeia (USP) Reference Standard
Guaifenesin,(S)
Guaifenesin(Guaiphenesin)
Guaifenesina
Guaifenesina [INN-Spanish]
Guaifenesine
Guaifenesine [INN-French]
Guaifenesinum
Guaifenesinum [INN-Latin]
Guaiphenesin
Guaiphenesin;Glyceryl guaiacolate
Guaiphenesine
Guaiphenezine
Guaiphesin
Guajacol-.alpha.-glycerin-ether
Guajacol-alpha-glycerinether
Guajacol-glycerinaether
Guajacol-glycerinaether [German]
Guajacuran
Guajamar
Guanar
Guayanesin
Guiaphenesin
Guiatuss
Gvaja
Halotussin
HMS1570K14
HMS1920B15
HMS2090K20
HMS2091H21
HMS2097K14
HMS2231M20
HMS3369E03
HMS3369N15
HMS3651I17
HMS3714K14
HMS500M10
HSDB 3089
HSRJKNPTNIJEKV-UHFFFAOYSA-N
HUMABID
Humibid
Humibid L.A
Humibid Sprinkle
Hustodil
Hustosil
Hustosil (TN)
HY-B0264
Hycotuss (Salt/Mix)
Hytuss
Hytuss-2X
I01-6723
IDI1_000248
InChI=1/C10H14O4/c1-13-9-4-2-3-5-10(9)14-7-8(12)6-11/h2-5,8,11-12H,6-7H2,1H
Isoclor Expectorant C
Isoclor Expectorant C (Salt/Mix)
J10304
K695
KB-69789
KBio1_000248
KBio2_001315
KBio2_003883
KBio2_006451
KBio3_001308
KBioGR_000972
KBioSS_001315
KS-00000KTG
KS-5306
KSC492I9H
Kwelcof (Salt/Mix)
LS-120551
LS-120552
Lufyllin-GG
Lufyllin-GG (Salt/Mix)
MCULE-8909929116
Metfenossidiolo
Methoxypropanediol
Methphenoxydiol
Metossipropandiolo
MFCD00016873
Mintosyl
Miocaina
Miocurin
Miorelax
MLS000028402
MolPort-001-759-987
Mucinex
Mucinex D (Salt/Mix)
Mucinex DM (Salt/Mix)
Mucostop
Muskurelax
MY 301
MY-301
Myocain
Myocaine
Myorelax
Myoscain
Myoscaine
Naldecon Senior EX
Naldecon-EX (Salt/Mix)
NCGC00016350-01
NCGC00094689-01
NCGC00094689-02
NCGC00094689-03
NCGC00094689-04
NCGC00094689-06
NCGC00255343-01
Neothylline-GG (Salt/Mix)
Neuroton
Neurotone
NINDS_000248
NSC 62112
NSC-62112
NSC-757052
NSC62112
NSC757052
o-Methoxyphenyl glyceryl ether
Oprea1_193170
OR18315
Oresol
Oreson
Organidin NR
Pharmakon1600-01500321
Pneumomist
Pneumomist (Salt/Mix)
Pneumotussin HC (Salt/Mix)
Polaramine Expectorant (Salt/Mix)
Prestwick_231
Prestwick0_000776
Prestwick1_000776
Prestwick2_000776
Prestwick3_000776
Propanosedyl
PubChem21966
PV Tussin Tablet (Salt/Mix)
Q-Tussin
Q-Tussin (Salt/Mix)
Reduton
Relaxil G
Relaxyl-G
Reorganin
Resil
Respenyl
Respil
Resyl
Ritussin
Robitussin
ROBITUSSIN (TN)
Robitussin CF (Salt/Mix)
RTR-029185
Ru-Tuss DE Tablets (Salt/Mix)
s1740
SBI-0051397.P003
SC-18081
SCHEMBL4321
Scot-tussin Expectorant
Scott-Tussin
Sinumist-SR
Sirotol
SL-90
Slo-Phyllin GG (Salt/Mix)
SMR000058387
SPBio_001208
SPBio_002791
Spectrum_000835
SPECTRUM1500321
Spectrum2_001104
Spectrum3_000444
Spectrum4_000566
Spectrum5_000758
SR-01000737186
SR-01000737186-2
SR-01000737186-3
ST50330628
STK365152
SW196538-3
Tedral Expectorant
Tedral Expectorant (Salt/Mix)
Tenntus
Tenntuss
Theolair Plus (Salt/Mix)
Tolyn
Touro EX
Tox21_110389
Tox21_110389_1
Tox21_302094
TR-029185
Trecid
Triaminic (Salt/Mix)
Tulyl
Tulyn
Tussar SF (Salt/Mix)
Tussar-2 (Salt/Mix)
Tussi-Organidin NR
Tussi-Organidin NR (Salt/Mix)
Tussi-Organidin-S NR
Tussin
Uni-tussin
W-100252
WLN: Q1YQ1OR BO1
XL-90
ZX-AT008120
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
Actavis Labs Fl GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 091009-002 Sep 3, 2015 OTC No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071-002 May 27, 2015 OTC No No   Start Trial   Start Trial   Start Trial
Ohm Labs Inc GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 209254-001 Jul 16, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Guardian Drug GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 209215-002 Sep 6, 2017 OTC No No   Start Trial   Start Trial   Start Trial
Amneal Pharms GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 209692-002 Nov 1, 2018 OTC No No   Start Trial   Start Trial   Start Trial
>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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