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Last Updated: August 12, 2020

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DOXIL (LIPOSOMAL) Drug Profile

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When do Doxil (liposomal) patents expire, and when can generic versions of Doxil (liposomal) launch?

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. Fifteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Doxil (liposomal)

A generic version of DOXIL (LIPOSOMAL) was approved as doxorubicin hydrochloride by PHARMACIA AND UPJOHN on December 23rd, 1987.

  Start Trial

Summary for DOXIL (LIPOSOMAL)
Drug patent expirations by year for DOXIL (LIPOSOMAL)
Recent Clinical Trials for DOXIL (LIPOSOMAL)

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bobbie Jo Rimel, MDEarly Phase 1
Turku University HospitalPhase 4
University of PennsylvaniaPhase 4

See all DOXIL (LIPOSOMAL) clinical trials

Pharmacology 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   Start Trial   Start Trial   Start Trial
Baxter Hlthcare Corp DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-002 Jun 13, 2000 AB RX Yes No   Start Trial   Start Trial   Start 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 050718-001 Nov 17, 1995   Start Trial   Start Trial
Baxter Hlthcare Corp DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-002 Jun 13, 2000   Start Trial   Start Trial
Baxter Hlthcare Corp DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-001 Nov 17, 1995   Start Trial   Start Trial
Baxter Hlthcare Corp DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-002 Jun 13, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DOXIL (LIPOSOMAL)

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0252504 96C0046 Belgium   Start Trial PRODUCT NAME: DOXORUBICIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/96/011/001 19960624
0496835 C960031 Netherlands   Start 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   Start Trial PRODUCT NAME: DOXORUBICIN SULPHATE; REGISTERED: UK EU/1/96/011/001 19960621; UK EU/1/96/011/002 19960621
0496835 96C0047 Belgium   Start Trial PRODUCT NAME: ACIDE IBANDRONIQUE; REGISTRATION NO/DATE: EU/1/96/012/001 19960625
0496835 960031 Netherlands   Start Trial 960031, 20101020, EXPIRES: 20110620
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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