DAUNORUBICIN HYDROCHLORIDE Drug Patent Profile
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Which patents cover Daunorubicin Hydrochloride, and what generic alternatives are available?
Daunorubicin Hydrochloride is a drug marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Meitheal, and Teva Parenteral. and is included in seven NDAs.
The generic ingredient in DAUNORUBICIN HYDROCHLORIDE is daunorubicin hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Daunorubicin Hydrochloride
A generic version of DAUNORUBICIN HYDROCHLORIDE was approved as daunorubicin hydrochloride by HIKMA on January 30th, 1998.
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Summary for DAUNORUBICIN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 374 |
| Patent Applications: | 4,731 |
| 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 |
| Gilead Sciences | Phase 2 |
| Uwe Platzbecker | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | DAUNORUBICIN HYDROCHLORIDE | daunorubicin hydrochloride | INJECTABLE;INJECTION | 065034-001 | Nov 20, 2001 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Parenteral | DAUNORUBICIN HYDROCHLORIDE | daunorubicin hydrochloride | INJECTABLE;INJECTION | 064212-001 | Jun 23, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hisun Pharm Hangzhou | DAUNORUBICIN HYDROCHLORIDE | daunorubicin hydrochloride | INJECTABLE;INJECTION | 208759-001 | Apr 12, 2019 | 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 | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
