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Last Updated: October 27, 2021

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Details for New Drug Application (NDA): 021572


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NDA 021572 describes CUBICIN RF, which is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the CUBICIN RF profile page.

The generic ingredient in CUBICIN RF is daptomycin. There are ten drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
Summary for 021572
Tradename:CUBICIN RF
Applicant:Cubist Pharms Llc
Ingredient:daptomycin
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021572
Medical Subject Heading (MeSH) Categories for 021572
Suppliers and Packaging for NDA: 021572
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CUBICIN daptomycin POWDER;INTRAVENOUS 021572 NDA AUTHORIZED GENERIC Teva Parenteral Medicines, Inc. 0703-0125 0703-0125-01 1 VIAL, SINGLE-USE in 1 CARTON (0703-0125-01) > 10 mL in 1 VIAL, SINGLE-USE
CUBICIN daptomycin POWDER;INTRAVENOUS 021572 NDA Merck Sharp & Dohme Corp. 67919-011 67919-011-01 1 VIAL, SINGLE-USE in 1 CARTON (67919-011-01) > 10 mL in 1 VIAL, SINGLE-USE
Paragraph IV (Patent) Challenges for 021572
Tradename Dosage Ingredient NDA Submissiondate
CUBICIN RF POWDER;INTRAVENOUS daptomycin 021572 2008-11-19
CUBICIN POWDER;INTRAVENOUS daptomycin 021572 2008-11-19

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INTRAVENOUSStrength250MG/VIAL
Approval Date:Sep 12, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength500MG/VIAL
Approval Date:Sep 12, 2003TE:APRLD:Yes
Patent:⤷  Try it FreePatent Expiration:Sep 4, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength500MG/VIAL
Approval Date:Jul 6, 2016TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Nov 23, 2030Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021572

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 ⤷  Try it Free ⤷  Try it Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 ⤷  Try it Free ⤷  Try it Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 ⤷  Try it Free ⤷  Try it Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 ⤷  Try it Free ⤷  Try it Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 ⤷  Try it Free ⤷  Try it Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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