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Daptomycin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for daptomycin?

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 two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-seven patent family members in nineteen 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:3
Applicants:4
NDAs:4
Drug Master File Entries: see list9
Suppliers / Packagers: see list4
Bulk Api Vendors: see list49
Clinical Trials: see list18
Patent Applications: see list1,916
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:daptomycin at DailyMed

Pharmacology for Ingredient: daptomycin

Ingredient-typeLipopeptides
Drug ClassLipopeptide Antibacterial

Tentative approvals for DAPTOMYCIN

Applicant Application No. Form Dosage
► Subscribe► SubscribePOWDER;INTRAVENOUS350MG/VIAL
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Crane Pharms Llc
DAPTOMYCIN
daptomycin
POWDER;INTRAVENOUS206005-001Jun 15, 2016RXNoNo► Subscribe► Subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003RXYesYes8,003,673► Subscribe ► Subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;IV (INFUSION)021572-001Sep 12, 2003DISCNNoNo► Subscribe► Subscribe
Cubist Pharms Llc
CUBICIN RF
daptomycin
POWDER;INTRAVENOUS021572-003Jul 6, 2016RXYesYes9,138,456► SubscribeY ► Subscribe
Teva Parenteral
DAPTOMYCIN
daptomycin
POWDER;INTRAVENOUS091039-001Mar 25, 2016RXNoNo► Subscribe► 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;IV (INFUSION)021572-001Sep 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
8,835,382Lipopeptide 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
China104056250► Subscribe
EcuadorSP12011939► Subscribe
World Intellectual Property Organization (WIPO)2011063419► Subscribe
Peru15172012► Subscribe
Canada2610716► 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
C0022France► SubscribePRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
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.
/2006Austria► SubscribePRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
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