Mitoxantrone hydrochloride - Generic Drug Details
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What are the generic drug sources for mitoxantrone hydrochloride and what is the scope of freedom to operate?
Mitoxantrone hydrochloride
is the generic ingredient in two branded drugs marketed by Fresenius Kabi Oncol, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, Rising, and Emd Serono, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for mitoxantrone hydrochloride. Two suppliers are listed for this compound.
Summary for mitoxantrone hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 8 |
| Drug Master File Entries: | 6 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 380 |
| Patent Applications: | 7,458 |
| What excipients (inactive ingredients) are in mitoxantrone hydrochloride? | mitoxantrone hydrochloride excipients list |
| DailyMed Link: | mitoxantrone hydrochloride at DailyMed |
Recent Clinical Trials for mitoxantrone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Acute Leukemia French Association | Phase 2 |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | N/A |
| CSPC Ouyi Pharmaceutical Co., Ltd. | N/A |
Pharmacology for mitoxantrone hydrochloride
| Drug Class | Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for mitoxantrone hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for mitoxantrone hydrochloride
US Patents and Regulatory Information for mitoxantrone hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Meitheal | MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 077356-001 | Apr 11, 2006 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Meitheal | MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 077356-002 | Apr 11, 2006 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 076611-001 | Apr 11, 2006 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 201014-001 | Dec 11, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Oncol | MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 078606-001 | May 14, 2008 | 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 |
Expired US Patents for mitoxantrone hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Emd Serono | NOVANTRONE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 019297-001 | Dec 23, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Emd Serono | NOVANTRONE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 019297-001 | Dec 23, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Emd Serono | NOVANTRONE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 019297-001 | Dec 23, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Emd Serono | NOVANTRONE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 019297-003 | Dec 23, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Emd Serono | NOVANTRONE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 019297-001 | Dec 23, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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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