IXABEPILONE - Generic Drug Details

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What are the generic sources for ixabepilone and what is the scope of patent protection?

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
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Allarity Therapeutics	Phase 2
R-Pharm-US, LLC	Phase 2
R-Pharm US, Inc.	Phase 2

See all IXABEPILONE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for IXABEPILONE

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

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

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Glossary

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

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

International Patents for IXABEPILONE

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Country	Patent Number	Title	Estimated Expiration
Iceland	6950		⤷ Sign Up
Brazil	PI0207961	uso de análogos de epotilona e capecitabina para fabricar medicamento para tratar tumores cancerosos sólidos e kit compreendendo os referidos compostos.	⤷ Sign Up
Spain	2384789		⤷ Sign Up
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.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for IXABEPILONE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1019389	C01019389/01	Switzerland	⤷ Sign Up	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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