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Generated: November 15, 2018

DrugPatentWatch Database Preview

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. Seven 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
Ingredient-typeLipopeptides
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 RF 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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;IV (INFUSION)Strength250MG/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
Regulatory Exclusivity Expiration:Mar 29, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Sep 1, 2020
Regulatory Exclusivity Use:PROVIDES FOR LABELING CHANGES REGARDING THE USE OF DAPTOMYCIN IN THE PEDIATRIC POPULATION FOR STAPHYLOCOCCUS AUREUS BACTEREMIA (SAB) BASED ON RESULTS OF A TRIAL IN PEDIATRIC PATIENTS 1 TO 17 YEARS OF AGE

Expired US Patents for NDA 021572

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms Llc CUBICIN daptomycin POWDER;IV (INFUSION) 021572-001 Sep 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;IV (INFUSION) 021572-001 Sep 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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