ADRIAMYCIN PFS Drug Patent Profile
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Which patents cover Adriamycin Pfs, and what generic alternatives are available?
Adriamycin Pfs is a drug marketed by Pfizer and is included in one NDA.
The generic ingredient in ADRIAMYCIN PFS 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 Adriamycin Pfs
A generic version of ADRIAMYCIN PFS was approved as doxorubicin hydrochloride by PFIZER on December 23rd, 1987.
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Questions you can ask:
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Summary for ADRIAMYCIN PFS
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 531 |
| Patent Applications: | 4,394 |
| DailyMed Link: | ADRIAMYCIN PFS at DailyMed |
Recent Clinical Trials for ADRIAMYCIN PFS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Regeneron Pharmaceuticals | Phase 3 |
| Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Phase 2 |
| Ottawa Hospital Research Institute | Phase 4 |
US Patents and Regulatory Information for ADRIAMYCIN PFS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | ADRIAMYCIN PFS | doxorubicin hydrochloride | INJECTABLE;INJECTION | 063165-001 | Jan 30, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | ADRIAMYCIN PFS | doxorubicin hydrochloride | INJECTABLE;INJECTION | 063165-002 | Jan 30, 1991 | 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 ADRIAMYCIN PFS
| 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 |
