GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Guaifenesin And Pseudoephedrine Hydrochloride, and what generic alternatives are available?
Guaifenesin And Pseudoephedrine Hydrochloride is a drug marketed by Actavis Labs Fl, Aurobindo Pharma Ltd, Dr Reddys, Granules, L Perrigo Co, and Sun Pharm Inds Inc. and is included in six NDAs.
The generic ingredient in GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE 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 And Pseudoephedrine Hydrochloride
A generic version of GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE was approved as guaifenesin; pseudoephedrine hydrochloride by ACTAVIS LABS FL on May 27th, 2015.
Summary for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 27 |
| Clinical Trials: | 4 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE? | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE excipients list |
| DailyMed Link: | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dr. Reddy's Laboratories Limited | Phase 1 |
| Reckitt Benckiser Inc. | Phase 4 |
| Reckitt Benckiser LLC | Phase 4 |
See all GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials
Pharmacology for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
| Drug Class | Expectorant alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Anatomical Therapeutic Chemical (ATC) Classes for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
US Patents and Regulatory Information for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
| 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 AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091071-001 | May 27, 2015 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Granules | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 216082-002 | Aug 22, 2022 | DISCN | 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 | 213203-001 | Mar 25, 2020 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| 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 | ||||
| Granules | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 216082-001 | Aug 22, 2022 | DISCN | 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 |
