PSEUDOEPHEDRINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Pseudoephedrine Hydrochloride, and what generic alternatives are available?
Pseudoephedrine Hydrochloride is a drug marketed by Aurobindo Pharma, L Perrigo Co, Sun Pharm Inds Ltd, Cent Pharms, Graham Dm, Kv Pharm, and Sandoz. and is included in eight NDAs.
The generic ingredient in PSEUDOEPHEDRINE HYDROCHLORIDE is pseudoephedrine hydrochloride; triprolidine hydrochloride. There are forty-nine drug master file entries for this compound. Additional details are available on the pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.
Summary for PSEUDOEPHEDRINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 30 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 69 |
| Patent Applications: | 1,488 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PSEUDOEPHEDRINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eurofarma Laboratorios S.A. | Phase 3 |
| John Muir Health | N/A |
| University of Maryland, Baltimore | Phase 4 |
Pharmacology for PSEUDOEPHEDRINE HYDROCHLORIDE
| Drug Class | alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for PSEUDOEPHEDRINE HYDROCHLORIDE
US Patents and Regulatory Information for PSEUDOEPHEDRINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | PSEUDOEPHEDRINE HYDROCHLORIDE | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209008-001 | Jun 9, 2017 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Kv Pharm | PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE | chlorpheniramine maleate; pseudoephedrine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 071455-001 | Mar 1, 1989 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Cent Pharms | PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE | chlorpheniramine maleate; pseudoephedrine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019428-001 | Aug 2, 1988 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sandoz | PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE | pseudoephedrine hydrochloride; triprolidine hydrochloride | TABLET;ORAL | 088193-001 | May 17, 1983 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| L Perrigo Co | PSEUDOEPHEDRINE HYDROCHLORIDE | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 075153-001 | Feb 26, 1999 | OTC | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sun Pharm Inds Ltd | PSEUDOEPHEDRINE HYDROCHLORIDE | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 077442-001 | Sep 28, 2005 | 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 |
