DAPTOMYCIN - Generic Drug Details

What are the generic drug sources for daptomycin and what is the scope of freedom to operate?

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

Daptomycin has ninety-three patent family members in thirty-eight countries.

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

Summary for DAPTOMYCIN

International Patents:	93
US Patents:	7
Tradenames:	5
Applicants:	21
NDAs:	31
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	92
Patent Applications:	7,084
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
Chang Gung Memorial Hospital	N/A
Pfizer	Phase 2
University Magna Graecia	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
Dr Reddys	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	211403-001	Aug 31, 2020	AP	RX	No	No
Xellia Pharms Aps	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	217415-002	Jan 30, 2023		RX	Yes	Yes			Y
Qilu Pharm Hainan	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	215316-001	Aug 24, 2021	AP	RX	No	Yes
Mylan Labs Ltd	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	205037-001	Jun 5, 2018	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	021572-001	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	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

EU/EMA Drug Approvals for DAPTOMYCIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Daptomycin Hospira	daptomycin	EMEA/H/C/004310 Daptomycin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB).In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	yes	no	no	2017-03-22
Merck Sharp & Dohme B.V.	Cubicin	daptomycin	EMEA/H/C/000637 Cubicin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2006-01-19

International Patents for DAPTOMYCIN

Country	Patent Number	Title	Estimated Expiration
Cyprus	1120854
Ecuador	SP12011939	Compuestos Lipopéptidos y métodos relacionados
Chile	2015002412	Composición farmacéutica sólida de daptomicina; método de fabricación; y uso para tratar infecciones bacterianas (divisional de la sol. 1336-2012)
Japan	6239167

Supplementary Protection Certificates for DAPTOMYCIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	CA 2006 00018	Denmark		PRODUCT NAME: DAPTOMYCIN