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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Citi
McKinsey
Merck
Colorcon
Fish and Richardson
Federal Trade Commission
Moodys
Baxter
Healthtrust

Generated: December 18, 2017

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. Four suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

Summary for 021572

Tradename:2
Applicant:1
Ingredient:1
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 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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;IV (INFUSION)Strength250MG/VIAL
Approval Date:Sep 12, 2003TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength500MG/VIAL
Approval Date:Sep 12, 2003TE:APRLD:Yes
Regulatory Exclusivity Expiration:Sep 1, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Mar 29, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired Orange Book Patents for NDA: 021572

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms LlcCUBICINdaptomycinPOWDER;INTRAVENOUS021572-002Sep 12, 2003► Subscribe► Subscribe
Cubist Pharms LlcCUBICINdaptomycinPOWDER;IV (INFUSION)021572-001Sep 12, 2003► Subscribe► Subscribe
Cubist Pharms LlcCUBICINdaptomycinPOWDER;INTRAVENOUS021572-002Sep 12, 2003► Subscribe► Subscribe
Cubist Pharms LlcCUBICINdaptomycinPOWDER;IV (INFUSION)021572-001Sep 12, 2003► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Queensland Health
McKesson
Colorcon
Citi
Accenture
Deloitte
Moodys
US Department of Justice
Fuji
Medtronic

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.

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