Daptomycin - Generic Drug Details

What are the generic sources for daptomycin and what is the scope of patent protection?

Daptomycin is the generic ingredient in four branded drugs marketed by Cubist Pharms Llc, Accord Hlthcare, Be Pharms, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hangzhou Zhongmei, Hisun Pharm Hangzhou, Hospira Inc, Jiangsu Pharms, Meitheal, Mylan Labs Ltd, Qilu Pharm Hainan, Sagent Pharms Inc, Teva Pharms Usa, Xellia Pharms Aps, and Baxter Hlthcare Corp, and is included in twenty-four NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Daptomycin has seventy-two patent family members in thirty-seven countries.

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

Summary for daptomycin

International Patents:	72
US Patents:	5
Tradenames:	4
Applicants:	17
NDAs:	24
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	89
Patent Applications:	7,186
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
Sunnybrook Health Sciences Centre	Phase 4
University of Melbourne	Phase 4
Berry Consultants	Phase 4

See all daptomycin clinical trials

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

Anatomical Therapeutic Chemical (ATC) Classes for daptomycin

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DAPTOMYCIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CUBICIN RF	For Injection	daptomycin	500 mg/vial	021572	1	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
Hospira Inc	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	210282-002	Jun 21, 2021		RX	Yes	Yes			Y
Hospira Inc	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	210282-001	Jun 21, 2021		RX	Yes	Yes			Y
Baxter Hlthcare Corp	DAPZURA RT	daptomycin	POWDER;INTRAVENOUS	213645-001	Jan 25, 2022		RX	Yes	Yes			Y
Sagent Pharms Inc	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	207104-001	Nov 15, 2019	AP	RX	No	No
Cubist Pharms Llc	CUBICIN RF	daptomycin	POWDER;INTRAVENOUS	021572-003	Jul 6, 2016		RX	Yes	Yes			Y
Sagent Pharms Inc	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	208385-001	Sep 12, 2017	AP	RX	Yes	Yes
Accord Hlthcare	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	211961-001	Jun 24, 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
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003
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	Title	Estimated Expiration
Ecuador	SP12011939	Compuestos Lipopéptidos y métodos relacionados
Taiwan	201141506	Daptomycin compositions and related methods
Morocco	37956	Formulations de daptomycine et leurs utilisations
Israel	219891	תכשירים של ליפופפטיד (Lipopeptide compositions)
Hungary	E13837694
Chile	2015002412	Composición farmacéutica sólida de daptomicina; método de fabricación; y uso para tratar infecciones bacterianas (divisional de la sol. 1336-2012)
Canada	2610716	DAPTOMYCINE POUR LE TRAITEMENT D'UN BIOFILM ET LA RECUPERATION D'UN CATHETER (DAPTOMYCIN FOR THE TREATMENT OF BIOFILM AND CATHETER SALVAGE)

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	06C0022	France		PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
1115417	SZ 22/2006	Austria		PRODUCT NAME: DAPTOMYCIN
1115417	CA 2006 00018	Denmark		PRODUCT NAME: DAPTOMYCIN