RUBEX Drug Patent Profile
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When do Rubex patents expire, and when can generic versions of Rubex launch?
Rubex is a drug marketed by Bristol Myers Squibb and is included in one NDA.
The generic ingredient in RUBEX is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Rubex
A generic version of RUBEX was approved as doxorubicin hydrochloride by PFIZER on December 23rd, 1987.
Summary for RUBEX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Patent Applications: | 4,394 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | RUBEX at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for RUBEX
US Patents and Regulatory Information for RUBEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | RUBEX | doxorubicin hydrochloride | INJECTABLE;INJECTION | 062926-001 | Apr 13, 1989 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | RUBEX | doxorubicin hydrochloride | INJECTABLE;INJECTION | 062926-002 | Apr 13, 1989 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | RUBEX | doxorubicin hydrochloride | INJECTABLE;INJECTION | 062926-003 | Apr 13, 1989 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 RUBEX
| 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 |
