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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Boehringer Ingelheim
McKesson
Moodys
Citi
Chubb
Mallinckrodt
Express Scripts
Federal Trade Commission
Queensland Health

Generated: July 27, 2017

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Daptomycin - Generic Drug Details

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What are the generic drug sources for daptomycin and what is the scope of daptomycin freedom to operate?

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.

Daptomycin has thirty-one 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:2
Applicants:4
NDAs:4
Drug Master File Entries: see list9
Suppliers / Packagers: see list4
Bulk Api Vendors: see list49
Clinical Trials: see list73
Patent Applications: see list3,312
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. Strength Dosage Form
► Subscribe► Subscribe350MG/VIALPOWDER;INTRAVENOUS
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;IV (INFUSION)021572-001Sep 12, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003APRXYesYes► Subscribe► Subscribe ► Subscribe
Cubist Pharms Llc
CUBICIN RF
daptomycin
POWDER;INTRAVENOUS021572-003Jul 6, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003APRXYesYes► Subscribe► Subscribe► Subscribe
Teva Parenteral
DAPTOMYCIN
daptomycin
POWDER;INTRAVENOUS091039-001Mar 25, 2016APRXNoNo► Subscribe► 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, 2003► Subscribe► Subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003► Subscribe► Subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;IV (INFUSION)021572-001Sep 12, 2003► Subscribe► Subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003► Subscribe► 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
9,662,397Lipopeptide 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
Dominican RepublicP2012000140► Subscribe
EcuadorSP12011939► Subscribe
Taiwan201141506► Subscribe
Japan2016147874► Subscribe
Peru17172015► 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
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
C0022France► SubscribePRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fuji
AstraZeneca
US Army
Moodys
Mallinckrodt
Farmers Insurance
Colorcon
Boehringer Ingelheim
Medtronic
Novartis

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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