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Guaifenesin - Generic Drug Details
What are the generic drug sources for guaifenesin and what is the scope of freedom to operate?
Guaifenesin
is the generic ingredient in eight branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Guardian Drug, Ohm Labs Inc, Perrigo R And D, Rb Hlth, Bkk Pharms, Sovereign Pharms, Eci Pharms Llc, and Dr Reddys Labs Ltd, and is included in thirteen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Guaifenesin has thirty-nine patent family members in nineteen countries.
There are twenty drug master file entries for guaifenesin. Fifty-seven suppliers are listed for this compound.
Summary for guaifenesin
| International Patents: | 39 |
| US Patents: | 6 |
| Tradenames: | 8 |
| Applicants: | 10 |
| NDAs: | 13 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 57 |
| Bulk Api Vendors: | 86 |
| Clinical Trials: | 29 |
| Patent Applications: | 4,826 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for guaifenesin |
| Drug Sales Revenues: | Drug sales revenues for guaifenesin |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for guaifenesin |
| DailyMed Link: | guaifenesin at DailyMed |
Recent Clinical Trials for guaifenesin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johnson & Johnson Consumer and Personal Products Worldwide | N/A |
| Hoffmann-La Roche | N/A |
| Ache Laboratorios Farmaceuticos S.A. | Phase 3 |
Recent Litigation for guaifenesin
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| RECKITT BENCKISER LLC v. AMNEAL PHARMACEUTICALS LLC | 2015-03-26 |
| Reckitt Benckiser LLC v. Aurobindo Pharma Limited | 2014-09-17 |
| Adams Respiratory Therapeutics, Inc. v. Perrigo Company | 2007-10-02 |
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bkk Pharms | FLOWTUSS | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 022424-001 | May 14, 2015 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Rb Hlth | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-001 | Jul 12, 2002 | OTC | Yes | 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 | ||||
| Rb Hlth | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-002 | Dec 18, 2002 | OTC | Yes | Yes | 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 |
International Patents for guaifenesin
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1276467 | Start Trial |
| Taiwan | 200733952 | Start Trial |
| Cyprus | 1108166 | Start Trial |
| China | 1655766 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
