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Generated: June 26, 2017
What are the generic sources for epirubicin hydrochloride and what is the scope of epirubicin hydrochloride freedom to operate?
Epirubicin hydrochloride is the generic ingredient in two branded drugs marketed by Hospira, Fresenius Kabi Usa, Fresenius Kabi Oncol, Impax Labs Inc, Ebewe Pharma, Actavis Totowa, Cipla Ltd, Akorn Inc, Mustafa Nevsat, Mylan Institutional, Hisun Pharm Hangzhou, Pfizer Inc, West-ward Pharms Int, and Mylan Labs Ltd, and is included in fifteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 1 |
| Applicants: | 14 |
| NDAs: | 15 |
| Drug Master File Entries: see list | 9 |
| Suppliers / Packagers: see list | 11 |
| Bulk Api Vendors: see list | 75 |
| Clinical Trials: see list | 2,512 |
| Patent Applications: see list | 6,743 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | epirubicin hydrochloride at DailyMed |
| Ingredient-type | Anthracyclines |
| Drug Class | Anthracycline Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Institutional | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065371-001 | Nov 28, 2007 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Pfizer Inc | ELLENCE | epirubicin hydrochloride | INJECTABLE;INJECTION | 050778-001 | Sep 15, 1999 | AP | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mustafa Nevsat | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 090266-001 | Apr 15, 2011 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Ebewe Pharma | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065339-001 | Dec 22, 2009 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Fresenius Kabi Usa | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065408-001 | Oct 15, 2007 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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