EPINASTINE HYDROCHLORIDE Drug Patent Profile
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When do Epinastine Hydrochloride patents expire, and when can generic versions of Epinastine Hydrochloride launch?
Epinastine Hydrochloride is a drug marketed by Apotex, Breckenridge, Chartwell Rx, Epic Pharma Llc, Somerset Theraps Llc, and Sun Pharm Inds. and is included in six NDAs.
The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinastine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Epinastine Hydrochloride
A generic version of EPINASTINE HYDROCHLORIDE was approved as epinastine hydrochloride by BRECKENRIDGE on March 14th, 2011.
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Summary for EPINASTINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 107 |
| Clinical Trials: | 15 |
| Patent Applications: | 422 |
| DailyMed Link: | EPINASTINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for EPINASTINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alcon Research | Phase 4 |
| Aston University | Phase 4 |
| University of Worcester | Phase 4 |
Pharmacology for EPINASTINE HYDROCHLORIDE
| Drug Class | Adrenergic Receptor Agonist Histamine-1 Receptor Inhibitor |
| Mechanism of Action | Adrenergic Agonists Histamine H1 Receptor Antagonists |
| Physiological Effect | Decreased Histamine Release |
Anatomical Therapeutic Chemical (ATC) Classes for EPINASTINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for EPINASTINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ELESTAT | Ophthalmic Solution | epinastine hydrochloride | 0.05% | 021565 | 1 | 2008-10-14 |
US Patents and Regulatory Information for EPINASTINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | EPINASTINE HYDROCHLORIDE | epinastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 090919-001 | Oct 31, 2011 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Epic Pharma Llc | EPINASTINE HYDROCHLORIDE | epinastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204055-001 | May 5, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Breckenridge | EPINASTINE HYDROCHLORIDE | epinastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 090870-001 | Mar 14, 2011 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | EPINASTINE HYDROCHLORIDE | epinastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 203384-001 | Dec 7, 2016 | DISCN | 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 |
