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Last Updated: March 28, 2024

Ixabepilone - Generic Drug Details


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What are the generic sources for ixabepilone and what is the scope of freedom to operate?

Ixabepilone is the generic ingredient in one branded drug marketed by R-pharm Us Llc and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ixabepilone has thirty-four patent family members in twenty-six countries.

There is one drug master file entry for ixabepilone. One supplier is listed for this compound.

Summary for ixabepilone
International Patents:34
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 56
Clinical Trials: 114
Patent Applications: 7,346
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in ixabepilone?ixabepilone excipients list
DailyMed Link:ixabepilone at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ixabepilone
Generic Entry Date for ixabepilone*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ixabepilone

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

SponsorPhase
Allarity TherapeuticsPhase 2
Yale UniversityPhase 2
R-Pharm-US, LLCPhase 2

See all ixabepilone clinical trials

Paragraph IV (Patent) Challenges for IXABEPILONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
IXEMPRA KIT Injection ixabepilone 15 mg/vial and 45 mg/vial, single- use vials 022065 1 2012-04-16

US Patents and Regulatory Information for ixabepilone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-002 Oct 16, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-001 Oct 16, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 ixabepilone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-002 Oct 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-001 Oct 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-002 Oct 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-001 Oct 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-002 Oct 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-002 Oct 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ixabepilone

Country Patent Number Title Estimated Expiration
Mexico PA03008135 COMBINACION DE ANALOGOS DE EPOTILONA Y AGENTES QUIMIOTERAPEUTICOS PARA TRATAMIENTO DE ENFERMEDADES PROLIFERATIVAS. (COMBINATION OF EPOTHILONE ANALOGS AND CHEMOTHERAPEUTIC AGENTS FOR THE TREATMENT OF PROLIFERATIVE DISEASES.) ⤷  Try a Trial
Iceland 2882 ⤷  Try a Trial
Japan 2004529904 ⤷  Try a Trial
Hungary 230273 Egy epotilon analóg és kemoterápiás szerek kombinációja proliferatív betegségek kezelésére (Use of combination of an epothilone analog and chemotherapeutic agents for the treatment of proliferative diseases) ⤷  Try a Trial
Brazil 0207961 ⤷  Try a Trial
Hungary 0400203 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ixabepilone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1019389 C01019389/01 Switzerland ⤷  Try a Trial PRODUCT NAME: IXABEPILONE; REGISTRATION NUMBER/DATE: SWISSMEDIC 58880 27.02.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.