DOXORUBICIN HYDROCHLORIDE Drug Patent Profile
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Which patents cover Doxorubicin Hydrochloride, and what generic alternatives are available?
Doxorubicin Hydrochloride is a drug marketed by Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Norvium Bioscience, Pfizer, Pharmachemie Bv, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences. and is included in twenty-five NDAs.
The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Doxorubicin Hydrochloride
A generic version of DOXORUBICIN HYDROCHLORIDE was approved as doxorubicin hydrochloride by PFIZER on December 23rd, 1987.
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Summary for DOXORUBICIN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 21 |
| NDAs: | 25 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 102 |
| Clinical Trials: | 2,140 |
| Patent Applications: | 4,394 |
| What excipients (inactive ingredients) are in DOXORUBICIN HYDROCHLORIDE? | DOXORUBICIN HYDROCHLORIDE excipients list |
| DailyMed Link: | DOXORUBICIN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DOXORUBICIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| CarThera | Phase 2 |
| Mansoura University | Phase 2 |
| Regeneron Pharmaceuticals | Phase 3 |
Pharmacology for DOXORUBICIN HYDROCHLORIDE
| Drug Class | Anthracycline Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for DOXORUBICIN HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for DOXORUBICIN HYDROCHLORIDE
US Patents and Regulatory Information for DOXORUBICIN HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 215178-002 | Jul 16, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 064140-001 | Jul 28, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Lifesciences | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 212299-002 | Sep 10, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pharmachemie Bv | DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 063097-003 | May 21, 1990 | 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 |
EU/EMA Drug Approvals for DOXORUBICIN HYDROCHLORIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| YES Pharmaceutical Development Services GmbH | Celdoxome pegylated liposomal | doxorubicin hydrochloride | EMEA/H/C/005330 Celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline). |
Authorised | no | no | no | 2022-09-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
