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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.

Summary for daptomycin

International Patents:	33
US Patents:	2
Tradenames:	3
Applicants:	8
NDAs:	8
Drug Master File Entries:	9
Suppliers / Packagers:	5
Bulk Api Vendors:	68
Clinical Trials:	73
Patent Applications:	3,995
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for daptomycin
DailyMed Link:	daptomycin at DailyMed

Pharmacology for daptomycin

Ingredient-type	Lipopeptides
Drug Class	Lipopeptide Antibacterial

Medical Subject Heading (MeSH) Categories for daptomycin

Anti-Bacterial Agents

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
		350MG/VIAL	POWDER;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
Cubist Pharms Llc	CUBICIN RF	daptomycin	POWDER;INTRAVENOUS	021572-003	Jul 6, 2016		RX	Yes	Yes			Y
Mylan Labs Ltd	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	205037-001	Jun 5, 2018	AP	RX	No	No
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;IV (INFUSION)	021572-001	Sep 12, 2003		DISCN	No	No

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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
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;IV (INFUSION)	021572-001	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003

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
9,662,397	Lipopeptide compositions and related methods

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International Patents for daptomycin

Country	Document Number	Estimated Expiration
Colombia	6541585
Taiwan	201141506
Japan	6088681
Taiwan	201703791

Supplementary Protection Certificates for daptomycin

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