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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Colorcon
Cerilliant
Farmers Insurance
Federal Trade Commission
Daiichi Sankyo
Merck
Teva
Medtronic

Generated: June 19, 2018

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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 Cubist Pharms Llc, Crane Pharms Llc, Fresenius Kabi Usa, Hospira Inc, Mylan Labs Ltd, Teva Pharms Usa, Sagent Pharms, and Xellia Pharms Aps, and is included in eight 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-three patent family members in nineteen countries.

There are nine drug master file entries for daptomycin. Five 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
Synonyms for daptomycin
060D533
103060-53-3
2,2'-((3S,6S,9R,15S,18R,21S,24S)-30-((S)-2-((S)-4-amino-2-((S)-2-decanamido-3-(1H-indol-3-yl)propanamido)-4-oxobutanamido)-3-carboxypropanamido)-3-(2-(2-aminophenyl)-2-oxoethyl)-24-(3-amino
AB0012614
AB01274779_02
AB01274779-01
AC-1162
ACN-036875
AKOS005146218
AKOS024457871
AKOS025401343
AKOS026750170
AKOS032949840
AM000687
AM011338
AN-5525
Antibiotic A-21978 C0
AOB87734
AS-12931
BC677644
C12013
C72H101N17O26
CHEBI:600103
CHEMBL1649722
CHEMBL387675
CHEMBL404822
Cidecin
CS-1857
Cubicin
Cubicin (TN)
Cubicin Rf
D01080
D05HPI
D4229
Dapcin
Daptomicina
Daptomicina [Spanish]
Daptomycin (JAN/USAN/INN)
Daptomycin [USAN:INN:BAN]
Daptomycin for injection
Daptomycin Ready Made Solution
Daptomycin, cyclic lipopeptide antibiotic
Daptomycine
Daptomycine [French]
Daptomycinum
Daptomycinum [Latin]
DB00080
Deptomycin
DOAKLVKFURWEDJ-RWDRXURGSA-N
HY-B0108
LS-171846
LY 146032
LY-146032
LY146032
MFCD08282794
MK-3009
MolPort-003-846-138
MolPort-023-276-990
MolPort-046-033-485
N-(1-Oxodecyl)-L-tryptophyl-D-asparaginyl-L-?-aspartyl-L-threonylglycyl-L-ornithinyl-L-?-aspartyl-D-alanyl-L-?-aspartylglycyl-D-seryl-(3R)-3-methyl-L-?-glutamyl-?,2-diamino-?-oxo-benzene butanoic acid (13-4) lactone
N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine 1.13-3.4-lactone
N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine epsilon(1)-lactone
N-decanoyl-L-tryptophyl-L-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine 1.13-3.4-lactone
N-decanoyl-L-tryptophyl-L-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine epsilon(1)-lactone
N-Decanoyl-L-tryptophyl-L-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine epsilon1-lactone
N-decanoyl-L-tryptophyl-L-asparaginyl-N-[(3S,6S,9R,15S,18R,21S,24S,30S,31R)-3-[2-(2-aminophenyl)-2-oxoethyl]-24-(3-aminopropyl)-15,21-bis(carboxymethyl)-6-[(2R)-1-carboxypropan-2-yl]-9-(hydroxymethyl)-18,31-dimethyl-2,5,8,11,
NCGC00346517-01
NWQ5N31VKK
propyl)-6-(1-carboxypropan-2-yl)-9-(hydroxymethyl)-18,31-dimethyl-2,5,8,11,14,17,20,23,26,29-decaoxo-1-oxa-4,7,10,13,16,19,22,25,28-nonaazacyclohentriacontane-15,21-diyl)diacetic acid
Q-200927
S-7668
s1373
SCHEMBL13491700
SCHEMBL1650768
SCHEMBL28102
SCHEMBL8221756
SCHEMBL8221760
UNII-NWQ5N31VKK
Tentative approvals for DAPTOMYCIN
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up350MG/VIALPOWDER;INTRAVENOUS

US Patents and Regulatory Information for daptomycin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Xellia Pharms Aps DAPTOMYCIN daptomycin POWDER;IV (INFUSION) 209949-001 Oct 20, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cubist Pharms Llc CUBICIN RF daptomycin POWDER;INTRAVENOUS 021572-003 Jul 6, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan Labs Ltd DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 205037-001 Jun 5, 2018 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cubist Pharms Llc CUBICIN daptomycin POWDER;IV (INFUSION) 021572-001 Sep 12, 2003 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for daptomycin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms Llc CUBICIN daptomycin POWDER;IV (INFUSION) 021572-001 Sep 12, 2003 ➤ Sign Up ➤ Sign Up
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 ➤ Sign Up ➤ Sign Up
Cubist Pharms Llc CUBICIN daptomycin POWDER;IV (INFUSION) 021572-001 Sep 12, 2003 ➤ Sign Up ➤ Sign Up
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
8,835,382 Lipopeptide compositions and related methods ➤ Sign Up
9,662,397 Lipopeptide compositions and related methods ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for daptomycin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
22/2006 Austria ➤ Sign Up PRODUCT NAME: DAPTOMYCIN
2006 00018 Denmark ➤ Sign Up PRODUCT NAME: DAPTOMYCIN
C/GB06/024 United Kingdom ➤ Sign Up SUPPLEMENTARY 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 Austria ➤ Sign Up PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Cerilliant
Medtronic
Fuji
Covington
Accenture
Chinese Patent Office
Cipla
Citi

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