EPIRUBICIN HYDROCHLORIDE Drug Patent Profile
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When do Epirubicin Hydrochloride patents expire, and when can generic versions of Epirubicin Hydrochloride launch?
Epirubicin Hydrochloride is a drug marketed by Actavis Totowa, Cipla Ltd, Ebewe Pharma, Epic Pharma Llc, Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Hospira, Impax Labs Inc, Norvium Bioscience, and Zennova. and is included in fourteen NDAs.
The generic ingredient in EPIRUBICIN HYDROCHLORIDE is epirubicin hydrochloride. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Epirubicin Hydrochloride
A generic version of EPIRUBICIN HYDROCHLORIDE was approved as epirubicin hydrochloride by HIKMA on June 27th, 2007.
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Questions you can ask:
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Summary for EPIRUBICIN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 14 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 66 |
| Clinical Trials: | 475 |
| Patent Applications: | 5,837 |
| DailyMed Link: | EPIRUBICIN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for EPIRUBICIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jeeyun Lee | Phase 1/Phase 2 |
| Daiichi Sankyo | Phase 3 |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 1 |
Pharmacology for EPIRUBICIN HYDROCHLORIDE
| Drug Class | Anthracycline Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for EPIRUBICIN HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for EPIRUBICIN HYDROCHLORIDE
US Patents and Regulatory Information for EPIRUBICIN HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | POWDER;INTRAVENOUS | 050807-002 | Sep 15, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 091599-002 | Mar 12, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zennova | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 090266-001 | Apr 15, 2011 | 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 |
