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Guaifenesin - Generic Drug Details
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What are the generic drug sources for guaifenesin and what is the scope of guaifenesin freedom to operate?
Guaifenesin has thirty-nine patent family members in nineteen countries.
There are twenty drug master file entries for guaifenesin. Forty-eight suppliers are listed for this compound.
Summary for guaifenesin
| International Patents: | 39 |
| US Patents: | 4 |
| Tradenames: | 8 |
| Applicants: | 9 |
| NDAs: | 12 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 48 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 19 |
| Patent Applications: | 4,477 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for guaifenesin |
| DailyMed Link: | guaifenesin at DailyMed |
Medical Subject Heading (MeSH) Categories for guaifenesin
Synonyms for guaifenesin
| .alpha.-Glyceryl guaiacol ether |
| .alpha.-Glyceryl guaiacolate ether |
| ( inverted exclamation markA)-3-(o-Methoxyphenoxy)-1,2-propanediol |
| (+-)-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 |
| 27846P |
| 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 |
| 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 |
| CHEBI:91952 |
| 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-(glyceryl-13C3) |
| Guaifenesin-d3 |
| Guaifenesin, European Pharmacopoeia (EP) Reference Standard |
| Guaifenesin, pharmaceutical secondary standard; traceable to USP and PhEur |
| Guaifenesin, United States Pharmacopeia (USP) Reference Standard |
| 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 |
| 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 |
| Neothylline-GG (Salt/Mix) |
| Neuroton |
| Neurotone |
| NINDS_000248 |
| NSC 62112 |
| NSC-62112 |
| NSC-757052 |
| NSC62112 |
| NSC757052 |
| o-Methoxyphenyl glyceryl ether |
| Oprea1_193170 |
| OR049394 |
| OR163677 |
| OR18315 |
| OR206940 |
| 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 |
| ST50330628 |
| STK365152 |
| 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 | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Dr Reddys Labs Ltd | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208369-002 | Dec 29, 2017 | OTC | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Reckitt Benckiser | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-002 | Dec 18, 2002 | OTC | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Guardian Pharms | GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 209215-001 | Sep 6, 2017 | 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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Non-Orange Book US Patents for guaifenesin
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,985,420 | Sustained release of guaifenesin combination drugs | ➤ Sign Up |
| 7,985,421 | Sustained release formulations of guaifenesin and additional drug ingredients | ➤ Sign Up |
| 8,012,504 | Sustained release of guaifenesin combination drugs | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for guaifenesin
| Country | Document Number | Estimated Expiration |
|---|---|---|
| New Zealand | 521959 | ➤ Sign Up |
| Germany | 60133538 | ➤ Sign Up |
| Taiwan | I314866 | ➤ Sign Up |
| Japan | 2003531849 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
