MITOXANTRONE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for mitoxantrone hydrochloride and what is the scope of patent protection?
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: | 7,311 |
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
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 | 019297-002 | 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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