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, Rising, 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.
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Questions you can ask:
- What is the 5 year forecast for IDARUBICIN HYDROCHLORIDE?
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- What is Average Wholesale Price for IDARUBICIN HYDROCHLORIDE?
Summary for IDARUBICIN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 66 |
| Clinical Trials: | 273 |
| Patent Applications: | 6,623 |
| DailyMed Link: | IDARUBICIN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for IDARUBICIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kura Oncology, Inc. | Phase 1 |
| Acute Leukemia French Association | Phase 2 |
| Fred Hutchinson Cancer Center | Phase 1 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Parenteral | IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | INJECTABLE;INJECTION | 065037-003 | May 1, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Meitheal | IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | INJECTABLE;INJECTION | 065036-001 | May 1, 2002 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Parenteral | IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | INJECTABLE;INJECTION | 065037-002 | May 1, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | INJECTABLE;INJECTION | 065275-001 | Dec 14, 2006 | AP | RX | 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 |
