MITOXANTRONE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Mitoxantrone Hydrochloride, and when can generic versions of Mitoxantrone Hydrochloride launch?
Mitoxantrone Hydrochloride is a drug marketed by Fresenius Kabi Oncol, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, Mylan Labs Ltd, and Rising. and is included in seven NDAs.
The generic ingredient in MITOXANTRONE HYDROCHLORIDE is mitoxantrone hydrochloride. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mitoxantrone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Mitoxantrone Hydrochloride
A generic version of MITOXANTRONE HYDROCHLORIDE was approved as mitoxantrone hydrochloride by FRESENIUS KABI USA on April 11th, 2006.
Summary for MITOXANTRONE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 377 |
| Patent Applications: | 1,329 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | MITOXANTRONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for MITOXANTRONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pediatric Oncology Experimental Therapeutics Investigators' Consortium | Phase 1/Phase 2 |
| Lucile Packard Children's Hospital Foundation | Phase 1/Phase 2 |
| Stanford University | Phase 1/Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Oncol | MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 078606-001 | May 14, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Rising | MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 078980-002 | Apr 13, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 076611-001 | Apr 11, 2006 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Fresenius Kabi Usa | MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 077496-001 | Apr 11, 2006 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
