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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 patent protection?

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, Sagent Pharms Inc, Teva Pharms Usa, and Xellia Pharms Aps, and is included in sixteen 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-eight patent family members in thirty-one countries.

There are ten drug master file entries for daptomycin. Sixteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for daptomycin

International Patents:	48
US Patents:	2
Tradenames:	3
Applicants:	11
NDAs:	16
Drug Master File Entries:	10
Suppliers / Packagers:	16
Bulk Api Vendors:	40
Clinical Trials:	81
Patent Applications:	7,060
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for daptomycin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for daptomycin
What excipients (inactive ingredients) are in daptomycin?	daptomycin excipients list
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
University Hospital, Caen	Phase 1
Vancouver Island Health Authority	Phase 4
Instituto de Salud Carlos III	Phase 4

See all daptomycin clinical trials

Generic filers with tentative approvals for DAPTOMYCIN

Applicant	Application No.	Strength	Dosage Form
		350MG/VIAL	POWDER;INTRAVENOUS
		350MG/VIAL	POWDER;IV (INFUSION)

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

Paragraph IV (Patent) Challenges for DAPTOMYCIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
CUBICIN RF	POWDER;INTRAVENOUS	daptomycin	021572	2008-11-19
CUBICIN	POWDER;INTRAVENOUS	daptomycin	021572	2008-11-19

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 Inc	DAPTOMYCIN	daptomycin	POWDER;IV (INFUSION)	208385-001	Sep 12, 2017	AP	RX	Yes	Yes
Jiangsu Hengrui Med	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	212022-001	Aug 22, 2019	AP	RX	No	No
Sagent Pharms Inc	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	207104-001	Nov 15, 2019	AP	RX	No	No

Expired US Patents for daptomycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	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
Cyprus	1120854
Chile	2012001336
Croatia	P20181380

Supplementary Protection Certificates for daptomycin

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