IDARUBICIN HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for idarubicin hydrochloride and what is the scope of patent protection?
Idarubicin hydrochloride
is the generic ingredient in three branded drugs marketed by Pfizer, Fresenius Kabi Usa, Hikma, Meitheal, Rising, Sandoz, and Teva Parenteral, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for idarubicin hydrochloride. Two suppliers are listed for this compound.
Summary for IDARUBICIN HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 7 |
NDAs: | 9 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 66 |
Clinical Trials: | 273 |
Patent Applications: | 7,453 |
What excipients (inactive ingredients) are in IDARUBICIN HYDROCHLORIDE? | IDARUBICIN HYDROCHLORIDE excipients list |
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 |
ImmunoGen, Inc. | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | INJECTABLE;INJECTION | 091293-001 | Mar 29, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Rising | IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | INJECTABLE;INJECTION | 200144-001 | Oct 11, 2012 | 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 | |||
Meitheal | IDARUBICIN HYDROCHLORIDE | idarubicin hydrochloride | INJECTABLE;INJECTION | 065036-001 | May 1, 2002 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Pfizer | IDAMYCIN | idarubicin hydrochloride | INJECTABLE;INJECTION | 050661-001 | Sep 27, 1990 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pfizer | IDAMYCIN | idarubicin hydrochloride | INJECTABLE;INJECTION | 050661-003 | Apr 25, 1995 | 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 |
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