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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-type	Lipopeptides

Medical Subject Heading (MeSH) Categories for 021572

Anti-Bacterial Agents

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:	DISCN	Dosage:	POWDER;IV (INFUSION)			Strength	250MG/VIAL
Approval Date:	Sep 12, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	500MG/VIAL
Approval Date:	Sep 12, 2003	TE:	AP	RLD:	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

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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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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 verifification 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.