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Last Updated: May 27, 2022

IXEMPRA KIT Drug Patent Profile


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Which patents cover Ixempra Kit, and what generic alternatives are available?

Ixempra Kit is a drug marketed by R-pharm Us Llc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-five patent family members in thirty-five countries.

The generic ingredient in IXEMPRA KIT is ixabepilone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ixabepilone profile page.

DrugPatentWatch® Generic Entry Outlook for Ixempra Kit

Ixempra Kit was eligible for patent challenges on October 16, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 23, 2022. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for IXEMPRA KIT
Drug Prices for IXEMPRA KIT

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for IXEMPRA KIT
Generic Entry Date for IXEMPRA KIT*:
Constraining patent/regulatory exclusivity:
NDA:
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 IXEMPRA KIT

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

SponsorPhase
R-Pharm-US, LLCPhase 2
R-Pharm US, Inc.Phase 2
Yale UniversityPhase 2

See all IXEMPRA KIT clinical trials

Paragraph IV (Patent) Challenges for IXEMPRA KIT
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 IXEMPRA KIT

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 022065-001 Oct 16, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-002 Oct 16, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-001 Oct 16, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-002 Oct 16, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-001 Oct 16, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-001 Oct 16, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 IXEMPRA KIT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-001 Oct 16, 2007 See Plans and Pricing See Plans and Pricing
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-001 Oct 16, 2007 See Plans and Pricing See Plans and Pricing
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-002 Oct 16, 2007 See Plans and Pricing See Plans and Pricing
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-002 Oct 16, 2007 See Plans and Pricing See Plans and Pricing
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-002 Oct 16, 2007 See Plans and Pricing See Plans and Pricing
R-pharm Us Llc IXEMPRA KIT ixabepilone INJECTABLE;INTRAVENOUS 022065-001 Oct 16, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for IXEMPRA KIT

See the table below for patents covering IXEMPRA KIT around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1019389 DERIVES D'EPOTHILONE (EPOTHILONE DERIVATIVES) See Plans and Pricing
Poland 368973 See Plans and Pricing
Poland 368636 See Plans and Pricing
Argentina 032408 FORMULACION PARENTERAL PARA ANALOGOS DE EPOTILONA See Plans and Pricing
Hong Kong 1026905 See Plans and Pricing
Poland 207720 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IXEMPRA KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1019389 C01019389/01 Switzerland See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
McKesson
Express Scripts
Medtronic
AstraZeneca

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.