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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.

Summary for daptomycin

International Patents:	44
US Patents:	2
Tradenames:	3
Applicants:	11
NDAs:	13
Drug Master File Entries:	10
Suppliers / Packagers:	17
Bulk Api Vendors:	78
Clinical Trials:	79
Patent Applications:	4,858
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for daptomycin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for daptomycin
DailyMed Link:	daptomycin at DailyMed

See drug prices for daptomycin

Recent Clinical Trials for daptomycin

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

Sponsor	Phase
Institut d'Investigació Biomèdica de Bellvitge	Phase 4
Instituto de Salud Carlos III	Phase 4
Merck Sharp & Dohme Corp.	Phase 2

See all daptomycin clinical trials

Recent Litigation for daptomycin

Identify potential future generic entrants

District Court Litigation

Case Name	Date
CUBIST PHARMACEUTICALS LLC v. CIPLA USA INC.	2019-05-24
Cubist Pharmaceuticals LLC v. Crane Pharmaceuticals LLC	2016-02-10
Cubist Pharmaceuticals LLC v. Sagent Pharmaceuticals, Inc.	2015-12-17

See all daptomycin litigation

PTAB Litigation

Petitioner	Date
Fresenius Kabi USA LLC	2015-07-10
Fresenius-Kabi USA LLC	2014-11-03
Agila Specialties Inc.	2014-10-24

See all daptomycin litigation

Generic filers with tentative approvals for DAPTOMYCIN

Applicant	Application No.	Strength	Dosage Form
		350MG/VIAL	POWDER;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

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

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
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003	AP	RX	Yes	Yes
Dr Reddys	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	208375-001	May 1, 2019	AP	RX	No	No
Cubist Pharms Llc	CUBICIN RF	daptomycin	POWDER;INTRAVENOUS	021572-003	Jul 6, 2016		RX	Yes	Yes
Jiangsu Hengrui Med	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	212022-001	Aug 22, 2019	AP	RX	No	No
Teva Pharms Usa	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	091039-001	Mar 25, 2016	AP	RX	No	No
Cubist Pharms Llc	CUBICIN RF	daptomycin	POWDER;INTRAVENOUS	021572-003	Jul 6, 2016		RX	Yes	Yes			Y

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;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
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

International Patents for daptomycin

Country	Patent Number	Estimated Expiration
Ecuador	SP12011939
Japan	2016147874
Denmark	2504353
Croatia	P20181380
World Intellectual Property Organization (WIPO)	2006130629
Taiwan	201141506
Canada	2781666

Supplementary Protection Certificates for daptomycin

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