Idarubicin hydrochloride - Generic Drug Details
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What are the generic drug sources for idarubicin hydrochloride and what is the scope of freedom to operate?
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 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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