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, 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 fifteen NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for epirubicin hydrochloride. Two suppliers are listed for this compound.
Summary for EPIRUBICIN HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 12 |
| NDAs: | 15 |
| Drug Master File Entries: | 9 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 66 |
| Clinical Trials: | 475 |
| Patent Applications: | 7,142 |
| What excipients (inactive ingredients) are in EPIRUBICIN HYDROCHLORIDE? | EPIRUBICIN HYDROCHLORIDE excipients list |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065408-001 | Oct 15, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065371-002 | Nov 28, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 091599-001 | Mar 12, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065371-001 | Nov 28, 2007 | 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 |
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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.
ISSN: 2162-2639
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