Daunorubicin hydrochloride - Generic Drug Details
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What are the generic drug sources for daunorubicin hydrochloride and what is the scope of freedom to operate?
Daunorubicin hydrochloride
is the generic ingredient in two branded drugs marketed by Hikma, Sanofi Aventis Us, Wyeth Ayerst, Fresenius Kabi Usa, Hisun Pharm Hangzhou, Meitheal, and Teva Parenteral, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for daunorubicin hydrochloride. Two suppliers are listed for this compound.
Summary for daunorubicin hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 10 |
| Drug Master File Entries: | 9 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 374 |
| Patent Applications: | 7,347 |
| What excipients (inactive ingredients) are in daunorubicin hydrochloride? | daunorubicin hydrochloride excipients list |
| DailyMed Link: | daunorubicin hydrochloride at DailyMed |
Recent Clinical Trials for daunorubicin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | Phase 3 |
| Uwe Platzbecker | Phase 2 |
| Gilead Sciences | Phase 2 |
Pharmacology for daunorubicin hydrochloride
| Drug Class | Anthracycline Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for daunorubicin hydrochloride
US Patents and Regulatory Information for daunorubicin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Meitheal | DAUNORUBICIN HYDROCHLORIDE | daunorubicin hydrochloride | INJECTABLE;INJECTION | 065035-001 | Jan 24, 2000 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Parenteral | DAUNORUBICIN HYDROCHLORIDE | daunorubicin hydrochloride | INJECTABLE;INJECTION | 064212-002 | May 3, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hisun Pharm Hangzhou | DAUNORUBICIN HYDROCHLORIDE | daunorubicin hydrochloride | INJECTABLE;INJECTION | 206195-001 | Apr 25, 2019 | 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.
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