DAPTOMYCIN Drug Patent Profile

Which patents cover Daptomycin, and when can generic versions of Daptomycin launch?

Daptomycin is a drug marketed by Accord Hlthcare, Aspiro, Be Pharms, 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 twenty-eight NDAs. There are three patents protecting this drug.

This drug has thirty-five patent family members in twenty-two countries.

The generic ingredient in DAPTOMYCIN is daptomycin. There are ten drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Daptomycin

A generic version of DAPTOMYCIN was approved as daptomycin by TEVA PHARMS USA on March 25^th, 2016.

Summary for DAPTOMYCIN

International Patents:	35
US Patents:	3
Applicants:	19
NDAs:	28
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	91
Patent Applications:	4,556
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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
Pfizer	Phase 2
University Magna Graecia	Phase 4
Sunnybrook Health Sciences Centre	Phase 4

See all DAPTOMYCIN clinical trials

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

DAPTOMYCIN is protected by three US patents.

Patents protecting DAPTOMYCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	daptomycin	SOLUTION;INTRAVENOUS	213645-005	Feb 27, 2023		RX	Yes	Yes
Xellia Pharms Aps	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	209949-001	Oct 20, 2017		RX	Yes	Yes
Baxter Hlthcare Corp	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	daptomycin	SOLUTION;INTRAVENOUS	213645-002	Feb 27, 2023		RX	Yes	Yes
Xellia Pharms Aps	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	217415-001	Jan 30, 2023		RX	Yes	Yes			Y
Accord Hlthcare	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	212667-001	Jul 12, 2019	AP	RX	No	No
Hospira	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	210282-002	Jun 21, 2021		RX	Yes	Yes			Y

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

See the table below for patents covering DAPTOMYCIN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2895187	FORMULATIONS DE DAPTOMYCINE ET LEURS UTILISATIONS (DAPTOMYCIN FORMULATIONS AND USES THEREOF)
European Patent Office	3675815	FORMULATIONS DE DAPTOMYCINE (DAPTOMYCIN FORMULATIONS)
New Zealand	742241	Daptomycin formulations and uses thereof
Australia	2018322769	Daptomycin formulations
Mexico	2020001885	FORMULACIONES DE DAPTOMICINA. (DAPTOMYCIN FORMULATIONS.)
Russian Federation	2020111026	ПРЕПАРАТЫ ДАПТОМИЦИНА

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