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CUBICIN Drug Profile

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Cubicin is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and four patent family members in thirty countries.

The generic ingredient in CUBICIN is daptomycin. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the daptomycin profile page.

Summary for Tradename: CUBICIN

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: CUBICIN

Ingredient-typeLipopeptides
Drug ClassLipopeptide Antibacterial
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003RXYes6,468,967► subscribe ► subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;IV (INFUSION)021572-001Sep 12, 2003DISCNNo6,468,967► subscribe ► subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003RXYesRE39071► subscribeYY ► subscribe
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Expired Patents for Tradename: CUBICIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;IV (INFUSION)021572-001Sep 12, 20035,912,226► subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003RE39071► subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 20035,912,226► subscribe
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Paragraph IV activity for: CUBICIN

Drugname Dosage Strength RLD Submissiondate
daptomycinFor Injection500 mg/vialCubicin11/19/2008

Non-Orange Book Patents for Tradename: CUBICIN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,696,412 High purity lipopeptides, Lipopeptide micelles and processes for preparing same► subscribe
5,912,226 Anhydro- and isomer-A-21978C cyclic peptides► subscribe
9,358,267High purity lipopeptides► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: CUBICIN

Country Document Number Estimated Expiration
Iceland8807► subscribe
Japan5303087► subscribe
Austria449785► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CUBICIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB06/024United Kingdom► subscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB06/024 GRANTED TO CUBIST PHARMACEUTICALS, INC IN RESPECT OF THE PRODUCT DAPTOMYCIN, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6162 DATED 27 JUNE 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22 JANUARY 2021.
2006 00018Denmark► subscribe
0232Netherlands► subscribe300232, 20190924, EXPIRES: 20210118
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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.

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