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Epirubicin hydrochloride - Generic Drug Details
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, Mustafa Nevsat, Mylan Institutional, Mylan Labs Ltd, and West-ward Pharms Int, 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. Five 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: | 5 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 381 |
| Patent Applications: | 7,521 |
| 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 |
|---|---|
| Hebei Medical University Fourth Hospital | N/A |
| Renske Altena | Phase 2 |
| Dalian Municipal Central Hospital | Phase 2 |
Pharmacology for epirubicin hydrochloride
| Drug Class | Anthracycline Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for epirubicin hydrochloride
Synonyms for epirubicin hydrochloride
| (1S,3S)-3-Glycoloyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-alpha-L-arabino-hexopyranoside hydrochloride |
| (7S,9S)-7-[(2R,4S,5R,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione hydrochloride |
| (7S,9S)-7-[(2R,4S,5R,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione;hydrochloride |
| (8S-cis)-10-((3-Amino-2,3,6-trideoxy-alpha-L-arabino-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxynaphthacene-5,12-dione hydrochloride |
| (8S,10S)-10-((2R,4S,5R,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yloxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione hydrochloride |
| 22966TX7J5 |
| 33811-EP2275420A1 |
| 33811-EP2295055A2 |
| 33811-EP2295416A2 |
| 33811-EP2298748A2 |
| 33811-EP2298764A1 |
| 33811-EP2298765A1 |
| 33811-EP2305642A2 |
| 33811-EP2311453A1 |
| 4-Epidoxorubicin hydrochloride |
| 4'-epi-Adriamycin |
| 4'-epi-Adriamycin hydrochloride |
| 4'-epi-Doxorubicin |
| 4'-epi-DX |
| 4'-Epidoxorubicin hydrochloride |
| 5,12-Naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-L-arabino-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- |
| 5,12-Naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-L-arabinohexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S,10S)- |
| 56390-09-1 |
| 56420-45-2 (Parent) |
| AC1L233G |
| AKOS030526162 |
| BC208841 |
| BCP9000651 |
| BIFK0018 |
| CCG-100950 |
| CCRIS 4477 |
| CHEMBL1200981 |
| CPD000466308 |
| CS-1773 |
| D02214 |
| E-ADM |
| EINECS 260-145-2 |
| Ellence |
| Ellence (TN) |
| Epidoxorubicin hydrochloride |
| epirubicin (hydrochloride) |
| Epirubicin Ebewe |
| Epirubicin HCl |
| Epirubicin HCl (4'-epidoxorubicin) |
| Epirubicin hydrochlorid |
| Epirubicin hydrochloride (JP17/USAN) |
| Epirubicin hydrochloride [USAN:JAN] |
| Epirubicin hydrochloride [USAN:USP:JAN] |
| Epirubicin hydrochloride, >=90% (HPLC) |
| Epirubicin hydrochloride, British Pharmacopoeia (BP) Reference Standard |
| Epirubicin hydrochloride, European Pharmacopoeia (EP) Reference Standard |
| Epirubicin hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Epirubitec |
| EX-A2654 |
| Farmorubicin |
| Farmorubicina |
| HY-13624A |
| IMI-28 |
| LS-93989 |
| MLS000759412 |
| MLS001401404 |
| MolPort-003-666-844 |
| MWWSFMDVAYGXBV-FGBSZODSSA-N |
| NC00200 |
| NSC 256942 |
| NSC-759195 |
| NSC759195 |
| Pharmakon1600-01505708 |
| Pharmorubicin |
| Pidorubicin |
| Q-101406 |
| s1223 |
| SAM001246559 |
| SCHEMBL3165 |
| SMR000466308 |
| SR-01000763557 |
| SR-01000763557-3 |
| UNII-22966TX7J5 |
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 | 065411-001 | Aug 20, 2007 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Fresenius Kabi Usa | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065408-002 | Oct 15, 2007 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Cipla Ltd | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065361-001 | Oct 22, 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 verifification 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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Major Patent Expirations 2019 - 2020
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ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.