IXEMPRA KIT Drug Patent Profile

When do Ixempra Kit patents expire, and when can generic versions of Ixempra Kit launch?

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

Summary for IXEMPRA KIT

International Patents:	155
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	55
Patent Applications:	6,421
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for IXEMPRA KIT
DailyMed Link:	IXEMPRA KIT at DailyMed

See drug prices for IXEMPRA KIT

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for IXEMPRA KIT

NDA:

022065

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

Sponsor	Phase
R-Pharm US, Inc.	Phase 2
Yale University	Phase 2
R-Pharm-US, LLC	Phase 2

See all IXEMPRA KIT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for IXEMPRA KIT

L01DC	Other cytotoxic antibiotics
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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	022065-002	Oct 16, 2007
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-001	Oct 16, 2007
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-001	Oct 16, 2007
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-001	Oct 16, 2007

International Patents for IXEMPRA KIT

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

Country	Patent Number	Title	Estimated Expiration
Brazil	0206695
Poland	363362
Hungary	0103111
European Patent Office	1019389	DERIVES D'EPOTHILONE (EPOTHILONE DERIVATIVES)
Cyprus	1108114
Japan	4885067
Mexico	PA03007394	TRATAMIENTO DE TUMORES REFRACTARIOS MEDIANTE USO DE DERIVADOS DE EPOTILONA. (TREATMENT OF REFRACTORY TUMORS USING EPOTHILONE DERIVATIVES.)

Supplementary Protection Certificates for IXEMPRA KIT

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