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Serving leading biopharmaceutical companies globally:

Cerilliant
Colorcon
Medtronic
US Army
Fuji
Baxter
Boehringer Ingelheim
Citi
Mallinckrodt
Chinese Patent Office

Generated: November 23, 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, Cubist Pharms Llc, and Sagent Pharms, and is included in five 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 and four supplementary protection certificates in three 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.

Pharmacology for daptomycin

Ingredient-typeLipopeptides
Drug ClassLipopeptide Antibacterial

Medical Subject Heading (MeSH) Categories for daptomycin

Tentative approvals for DAPTOMYCIN

Applicant Application No. Strength Dosage Form
u► 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
Sagent Pharms
DAPTOMYCIN
daptomycin
POWDER;INTRAVENOUS208385-001Sep 12, 2017RXYesYes► 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
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;IV (INFUSION)021572-001Sep 12, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira Inc
DAPTOMYCIN
daptomycin
POWDER;INTRAVENOUS202857-001Sep 12, 2014APRXNoNo► Subscribe► Subscribe► Subscribe
Crane Pharms Llc
DAPTOMYCIN
daptomycin
POWDER;INTRAVENOUS206005-001Jun 15, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Cubist Pharms Llc
CUBICIN RF
daptomycin
POWDER;INTRAVENOUS021572-003Jul 6, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Cubist Pharms Llc
CUBICIN RF
daptomycin
POWDER;INTRAVENOUS021572-003Jul 6, 2016RXYesYes► 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;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;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
Chile2015002412► Subscribe
Peru15172012► Subscribe
New Zealand600118► Subscribe
Mexico2012005993► Subscribe
Dominican RepublicP2012000140► Subscribe
EcuadorSP12011939► Subscribe
Costa Rica20120271► Subscribe
Peru17172015► Subscribe
Canada2781666► Subscribe
Japan2016147874► 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
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.
22/2006Austria► SubscribePRODUCT NAME: DAPTOMYCIN
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 leading biopharmaceutical companies globally:

Dow
Farmers Insurance
Express Scripts
Harvard Business School
Moodys
Accenture
McKinsey
Novartis
US Army
Federal Trade Commission

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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