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Generated: November 16, 2018

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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 are six patents 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:6
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022065
Generic Entry Date for 022065*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;IV (INFUSION)

*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:RXDosage:INJECTABLE;INTRAVENOUSStrength15MG/VIAL
Approval Date:Oct 16, 2007TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 23, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jul 23, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Nov 26, 2018Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022065

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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Moodys
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Dow
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Cipla

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