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Epirubicin hydrochloride - Generic Drug Details
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What are the generic sources for epirubicin hydrochloride and what is the scope of freedom to operate?
Epirubicin hydrochloride
is the generic ingredient in two branded drugs marketed by Pfizer Inc, Actavis Totowa, Akorn Inc, Cipla Ltd, Ebewe Pharma, Fresenius Kabi Usa, Hisun Pharm Hangzhou, Hospira, Impax Labs Inc, Mylan Institutional, Mylan Labs Ltd, West-ward Pharms Int, and Zennova, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for epirubicin hydrochloride. Four suppliers are listed for this compound.
Summary for epirubicin hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 13 |
| NDAs: | 15 |
| Drug Master File Entries: | 9 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 56 |
| Clinical Trials: | 409 |
| Patent Applications: | 7,494 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | epirubicin hydrochloride at DailyMed |
Recent Clinical Trials for epirubicin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Phase 2 |
| Providence Health & Services | Phase 1 |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 2/Phase 3 |
Pharmacology for epirubicin hydrochloride
| Drug Class | Anthracycline Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065411-002 | Aug 20, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065408-003 | Oct 15, 2007 | RX | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hospira | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065343-003 | Apr 19, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Impax Labs Inc | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065331-002 | Aug 9, 2007 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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