DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) Drug Patent Profile
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Which patents cover Doxorubicin Hydrochloride (liposomal), and what generic alternatives are available?
Doxorubicin Hydrochloride (liposomal) is a drug marketed by Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Sun Pharm, and Zydus. and is included in five NDAs.
The generic ingredient in DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) 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 Doxorubicin Hydrochloride (liposomal)
A generic version of DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) was approved as doxorubicin hydrochloride by PFIZER on December 23rd, 1987.
Summary for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 102 |
| Clinical Trials: | 380 |
| Patent Applications: | 4,263 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) at DailyMed |
-patent-expirations.png "DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) drug patent expirations")
Recent Clinical Trials for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AIDS Malignancy Consortium | Phase 3 |
| Sham Sunder Kakar | Phase 1/Phase 2 |
| University of Louisville Health Care | Phase 1/Phase 2 |
See all DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) clinical trials
Pharmacology for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
| Drug Class | Anthracycline Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
US Patents and Regulatory Information for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ayana Pharma Ltd | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 207228-001 | Oct 12, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 203263-001 | Feb 4, 2013 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Baxter Hlthcare Corp | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 212219-002 | Oct 19, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 203263-002 | Feb 4, 2013 | AB | RX | No | Yes | ⤷ 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 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
| 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 |
