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Daptomycin - Generic Drug Details

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Daptomycin is the generic ingredient in three branded drugs marketed by Crane Pharms Llc, Teva Parenteral, Hospira Inc, and Cubist Pharms Llc, and is included in four NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and twenty-five patent family members in thirty-nine countries.

There are nine drug master file entries for daptomycin. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: daptomycin

Tradenames:3
Patents:7
Applicants:4
NDAs:4
Drug Master File Entries: see list9
Suppliers / Packaging: see list4
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: daptomycin

Ingredient-typeLipopeptides
Drug ClassLipopeptide Antibacterial

Tentative approvals for DAPTOMYCIN

Applicant Application No. Form Dosage
<disabled><disabled>POWDER;INTRAVENOUS350MG/VIAL
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;IV (INFUSION)021572-001Sep 12, 2003DISCNNo6,852,689► subscribe ► subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003RXYes8,129,342► subscribeYY ► subscribe
Cubist Pharms Llc
CUBICIN RF
daptomycin
POWDER;INTRAVENOUS021572-003Jul 6, 2016RXYes9,138,456► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: daptomycin

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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Non-Orange Book Patents for Generic Ingredient: daptomycin

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
8,853,357High purity lipopeptides► subscribe
4,874,843 Chromatographic purification process► subscribe
8,835,382Lipopeptide compositions and related methods► 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 Ingredient: daptomycin

Country Document Number Estimated Expiration
European Patent Office2940034► subscribe
South Africa200102389► subscribe
Russian Federation2002122114► 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: DAPTOMYCIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2006Austria► subscribePRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
254Luxembourg► subscribe91254, EXPIRES: 20210119
C 018/2006Ireland► subscribeSPC 018/2006: 20070523, 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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