IDARUBICIN HYDROCHLORIDE Drug Patent Profile
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When do Idarubicin Hydrochloride patents expire, and what generic alternatives are available?
Idarubicin Hydrochloride is a drug marketed by Fresenius Kabi Usa, Hikma, Meitheal, Mylan Labs Ltd, Sandoz, and Teva Parenteral. and is included in seven NDAs.
The generic ingredient in IDARUBICIN HYDROCHLORIDE is idarubicin hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the idarubicin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Idarubicin Hydrochloride
A generic version of IDARUBICIN HYDROCHLORIDE was approved as idarubicin hydrochloride by MEITHEAL on May 1st, 2002.
Summary for IDARUBICIN HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 6 |
NDAs: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 66 |
Clinical Trials: | 270 |
Patent Applications: | 6,273 |
Formulation / Manufacturing: | see details |
DailyMed Link: | IDARUBICIN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for IDARUBICIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ho Joon Im | Phase 2 |
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Phase 2 |
Zhongda Hospital | Phase 2/Phase 3 |
Pharmacology for IDARUBICIN HYDROCHLORIDE
Drug Class | Anthracycline Topoisomerase Inhibitor |
Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for IDARUBICIN HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for IDARUBICIN HYDROCHLORIDE
US Patents and Regulatory Information for IDARUBICIN 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 | IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | INJECTABLE;INJECTION | 065440-001 | Aug 4, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Teva Parenteral | IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | INJECTABLE;INJECTION | 065037-003 | May 1, 2002 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Meitheal | IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | INJECTABLE;INJECTION | 065036-001 | May 1, 2002 | 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 |