DAPTOMYCIN IN 0.9% SODIUM CHLORIDE Drug Patent Profile

When do Daptomycin In 0.9% Sodium Chloride patents expire, and what generic alternatives are available?

Daptomycin In 0.9% Sodium Chloride is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.

The generic ingredient in DAPTOMYCIN IN 0.9% SODIUM CHLORIDE is daptomycin. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Daptomycin In 0.9% Sodium Chloride

A generic version of DAPTOMYCIN IN 0.9% SODIUM CHLORIDE was approved as daptomycin by TEVA PHARMS USA on March 25^th, 2016.

Summary for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	91
Formulation / Manufacturing:	see details
DailyMed Link:	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

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

Sponsor	Phase
Pfizer	Phase 2
University Magna Graecia	Phase 4
Queensland University of Technology	Phase 4

See all DAPTOMYCIN IN 0.9% SODIUM CHLORIDE clinical trials

Pharmacology for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Drug Class

Lipopeptide Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

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

US Patents and Regulatory Information for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

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
Baxter Hlthcare Corp	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	daptomycin	SOLUTION;INTRAVENOUS	213645-004	Feb 27, 2023		RX	Yes	Yes
Baxter Hlthcare Corp	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	daptomycin	SOLUTION;INTRAVENOUS	213645-002	Feb 27, 2023		RX	Yes	Yes
Baxter Hlthcare Corp	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	daptomycin	SOLUTION;INTRAVENOUS	213645-003	Feb 27, 2023		RX	Yes	Yes

EU/EMA Drug Approvals for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

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 IN 0.9% SODIUM CHLORIDE

See the table below for patents covering DAPTOMYCIN IN 0.9% SODIUM CHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3170514	FORMULATIONS DE DAPTOMYCINE CONTENANT UNE ASSOCIATION DE SORBITOL ET DE MANNITOL (DAPTOMYCIN FORMULATIONS CONTAINING A COMBINATION OF SORBITOL AND MANNITOL)
Brazil	112022015170	FORMULAÇÕES DE DAPTOMICINA CONTENDO UMA COMBINAÇÃO DE SORBITOL E MANITOL
European Patent Office	4117625	FORMULATIONS DE DAPTOMYCINE CONTENANT UNE ASSOCIATION DE SORBITOL ET DE MANNITOL (DAPTOMYCIN FORMULATIONS CONTAINING A COMBINATION OF SORBITOL AND MANNITOL)
China	115243675	含有山梨糖醇和甘露糖醇的组合的达托霉素制剂 (Daptomycin formulations containing combination of sorbitol and mannitol)
World Intellectual Property Organization (WIPO)	2021183752
Australia	2021233893	Daptomycin formulations containing a combination of sorbitol and mannitol

Supplementary Protection Certificates for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

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