DOXIL (LIPOSOMAL) Drug Patent Profile
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Which patents cover Doxil (liposomal), and what generic alternatives are available?
Doxil (liposomal) is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.
The generic ingredient in DOXIL (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 Doxil (liposomal)
A generic version of DOXIL (LIPOSOMAL) was approved as doxorubicin hydrochloride by PFIZER on December 23rd, 1987.
Summary for DOXIL (LIPOSOMAL)
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 102 |
| Clinical Trials: | 905 |
| Patent Applications: | 4,263 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | DOXIL (LIPOSOMAL) at DailyMed |
-patent-expirations.png "DOXIL (LIPOSOMAL) drug patent expirations")
Recent Clinical Trials for DOXIL (LIPOSOMAL)
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Federal University of Health Science of Porto Alegre | Phase 3 |
| Johnny K. Lee | Phase 4 |
| NorthShore University HealthSystem | Phase 4 |
Pharmacology for DOXIL (LIPOSOMAL)
| Drug Class | Anthracycline Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for DOXIL (LIPOSOMAL)
US Patents and Regulatory Information for DOXIL (LIPOSOMAL)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-001 | Nov 17, 1995 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-002 | Jun 13, 2000 | AB | RX | Yes | 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 |
Expired US Patents for DOXIL (LIPOSOMAL)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-002 | Jun 13, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-002 | Jun 13, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-001 | Nov 17, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-001 | Nov 17, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for DOXIL (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 |
International Patents for DOXIL (LIPOSOMAL)
See the table below for patents covering DOXIL (LIPOSOMAL) around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 9105545 | ⤷ Try a Trial | |
| Japan | 2667051 | ⤷ Try a Trial | |
| European Patent Office | 0496813 | PROCEDE ET COMPOSITION A MICRORESERVOIR DE LIPOSOMES. (LIPOSOME MICRORESERVOIR COMPOSITION AND METHOD.) | ⤷ Try a Trial |
| Japan | 2889549 | ⤷ Try a Trial | |
| Finland | 921763 | ⤷ Try a Trial | |
| Finland | 921764 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DOXIL (LIPOSOMAL)
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0252504 | 96C0046 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DOXORUBICIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/96/011/001 19960624 |
| 0496835 | 96C0047 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ACIDE IBANDRONIQUE; REGISTRATION NO/DATE: EU/1/96/012/001 19960625 |
| 0496835 | 960031 | Netherlands | ⤷ Try a Trial | 960031, 20101020, EXPIRES: 20110620 |
| 0496835 | C960031 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DOXORUBICINESULFAAT VERKREGEN UIT DOXORUBICINEHYDROCHLORIDE EN AMMONIUMSULFAAT; REGISTRATION NO/DATE: EU/1/96/011/001 - EU/1/96/011/002 19960621 |
| 0496835 | SPC/GB96/053 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DOXORUBICIN SULPHATE; REGISTERED: UK EU/1/96/011/001 19960621; UK EU/1/96/011/002 19960621 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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