GUAIFENESIN Drug Patent Profile
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Which patents cover Guaifenesin, and when can generic versions of Guaifenesin launch?
Guaifenesin is a drug marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Granules, Guardian Drug, Marksans Pharma, Ohm Labs Inc, Perrigo R And D, Sun Pharm, Aurobindo Pharma Ltd, L Perrigo Co, and Sun Pharm Inds Inc. and is included in twenty-one NDAs.
The generic ingredient in GUAIFENESIN is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Guaifenesin
A generic version of GUAIFENESIN was approved as guaifenesin; pseudoephedrine hydrochloride by ACTAVIS LABS FL on May 27th, 2015.
Summary for GUAIFENESIN
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 76 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 31 |
| Patent Applications: | 2,983 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GUAIFENESIN |
| Drug Sales Revenues: | Drug sales revenues for GUAIFENESIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GUAIFENESIN |
| What excipients (inactive ingredients) are in GUAIFENESIN? | GUAIFENESIN excipients list |
| DailyMed Link: | GUAIFENESIN at DailyMed |
See drug prices for GUAIFENESIN
Recent Clinical Trials for GUAIFENESIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johnson & Johnson Consumer and Personal Products Worldwide | Phase 1 |
| Hoffmann-La Roche | |
| Massachusetts Eye and Ear Infirmary | N/A |
Pharmacology for GUAIFENESIN
| Drug Class | Expectorant |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Medical Subject Heading (MeSH) Categories for GUAIFENESIN
Anatomical Therapeutic Chemical (ATC) Classes for GUAIFENESIN
Paragraph IV (Patent) Challenges for GUAIFENESIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MUCINEX | Extended-release Tablets | guaifenesin | 600 mg and 1.2 gm | 021282 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Inc | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212542-001 | Apr 28, 2020 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma Ltd | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213203-002 | Mar 25, 2020 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sun Pharm | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 214781-001 | Jul 1, 2021 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
