Details for New Drug Application (NDA): 022065

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NDA 022065 describes IXEMPRA KIT, which is a drug marketed by R-pharm Us Llc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the IXEMPRA KIT profile page.

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.

Summary for 022065

Tradename:	IXEMPRA KIT
Applicant:	R-pharm Us Llc
Ingredient:	ixabepilone
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022065

Generic Entry Date for 022065^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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.

Suppliers and Packaging for NDA: 022065

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065	NDA	R-Pharm US Operating, LLC	70020-1910	70020-1910-1	1 KIT in 1 PACKAGE, COMBINATION (70020-1910-1) * 15 mg in 1 VIAL, SINGLE-USE * 8 mL in 1 VIAL, SINGLE-USE
IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065	NDA	R-Pharm US Operating, LLC	70020-1911	70020-1911-1	1 KIT in 1 PACKAGE, COMBINATION (70020-1911-1) * 45 mg in 1 VIAL, SINGLE-USE * 23.5 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	15MG/VIAL
Approval Date:	Oct 16, 2007	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Feb 21, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	45MG/VIAL
Approval Date:	Oct 16, 2007	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Feb 21, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022065

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

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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.