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Last Updated: October 19, 2019

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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 freedom to operate?

Daptomycin is the generic ingredient in three branded drugs marketed by Cubist Pharms Llc, Accord Hlthcare, Be Pharms, Dr Reddys, Fresenius Kabi Usa, Hospira Inc, Jiangsu Hengrui Med, Mylan Labs Ltd, Teva Pharms Usa, Xellia Pharms Aps, and Sagent Pharms, and is included in thirteen 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 forty-four patent family members in twenty-eight countries.

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

Drug Prices for daptomycin

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Recent Clinical Trials for daptomycin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Institut d'Investigació Biomèdica de BellvitgePhase 4
Instituto de Salud Carlos IIIPhase 4
Merck Sharp & Dohme Corp.Phase 2

See all daptomycin clinical trials

Recent Litigation for daptomycin

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District Court Litigation
Case NameDate
CUBIST PHARMACEUTICALS LLC v. CIPLA USA INC.2019-05-24
Cubist Pharmaceuticals LLC v. Crane Pharmaceuticals LLC2016-02-10
Cubist Pharmaceuticals LLC v. Sagent Pharmaceuticals, Inc.2015-12-17

See all daptomycin litigation

PTAB Litigation
PetitionerDate
Fresenius Kabi USA LLC2015-07-10
Fresenius-Kabi USA LLC2014-11-03
Agila Specialties Inc.2014-10-24

See all daptomycin litigation

Generic filers with tentative approvals for DAPTOMYCIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial350MG/VIALPOWDER;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for daptomycin
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
A1206
AB0012614
AB01274779_02
AB01274779-01
AC-1162
ACN-036875
AKOS005146218
AKOS024457871
AKOS025401343
AKOS026750170
AKOS032949840
AN-5525
Antibiotic A-21978 C0
AOB87734
AS-12931
BC677644
BRD-K25021320-001-01-3
C12013
C72H101N17O26
CHEBI:600103
CHEMBL1649722
CHEMBL387675
CHEMBL404822
Cidecin
CS-1857
Cubicin
Cubicin (TN)
Cubicin Rf
D01080
D4229
Dapcin
Daptomicina
Daptomicina [Spanish]
Daptomycin (JAN/USAN/INN)
Daptomycin [USAN:INN:BAN]
Daptomycin for injection
Daptomycin Ready Made Solution, 1 mg/mL in DMSO
Daptomycin, cyclic lipopeptide antibiotic
Daptomycine
Daptomycine [French]
Daptomycinum
Daptomycinum [Latin]
DB00080
Deptomycin
DOAKLVKFURWEDJ-RWDRXURGSA-N
EX-A1967
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-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
NCGC00346517-01
NCGC00346517-04
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
SR-01000872587
SR-01000872587-1
UNII-NWQ5N31VKK

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
Sagent Pharms DAPTOMYCIN daptomycin POWDER;IV (INFUSION) 208385-001 Sep 12, 2017 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Dr Reddys DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 208375-001 May 1, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Cubist Pharms Llc CUBICIN RF daptomycin POWDER;INTRAVENOUS 021572-003 Jul 6, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Jiangsu Hengrui Med DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 212022-001 Aug 22, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 091039-001 Mar 25, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Cubist Pharms Llc CUBICIN RF daptomycin POWDER;INTRAVENOUS 021572-003 Jul 6, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for daptomycin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1115417 SPC/GB06/024 United Kingdom   Start Trial 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.
1115417 22/2006 Austria   Start Trial PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
1115417 SZ 22/2006 Austria   Start Trial PRODUCT NAME: DAPTOMYCIN
1115417 06C0022 France   Start Trial PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
1115417 CA 2006 00018 Denmark   Start Trial PRODUCT NAME: DAPTOMYCIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
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Harvard Business School
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