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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Federal Trade Commission
Harvard Business School
Farmers Insurance
Johnson and Johnson
Moodys
Chubb
Covington
Merck

Generated: May 22, 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. Additional details are available on the CUBICIN RF profile page.

The generic ingredient in CUBICIN RF is daptomycin. There are nine drug master file entries for this compound. Five 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
Therapeutic Class:Antibacterials
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 N 0703-0125-01
CUBICIN daptomycin POWDER;INTRAVENOUS 021572 NDA Merck Sharp & Dohme Corp. 67919-011 N 67919-011-01

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

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Argus Health
Queensland Health
Cantor Fitzgerald
Colorcon
Teva
Citi
AstraZeneca
Chinese Patent Office

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