CUBICIN RF Drug Patent Profile

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

Cubicin Rf is a drug marketed by Cubist Pharms Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-seven patent family members in thirty-two countries.

The generic ingredient in CUBICIN RF 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 Cubicin Rf

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

Summary for CUBICIN RF

International Patents:	47
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	40
Patent Applications:	2,451
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CUBICIN RF
What excipients (inactive ingredients) are in CUBICIN RF?	CUBICIN RF excipients list
DailyMed Link:	CUBICIN RF at DailyMed

Recent Clinical Trials for CUBICIN RF

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

Sponsor	Phase
Vancouver Island Health Authority	Phase 4
McGill University Health Center	Phase 4
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4

See all CUBICIN RF clinical trials

Pharmacology for CUBICIN RF

Drug Class

Lipopeptide Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for CUBICIN RF

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

Paragraph IV (Patent) Challenges for CUBICIN RF

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 CUBICIN RF

CUBICIN RF is protected by one US patents.

Patents protecting CUBICIN RF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cubist Pharms Llc	CUBICIN RF	daptomycin	POWDER;INTRAVENOUS	021572-003	Jul 6, 2016		DISCN	Yes	No			Y

EU/EMA Drug Approvals for CUBICIN RF

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 CUBICIN RF

See the table below for patents covering CUBICIN RF around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	449785
Hong Kong	1151546
New Zealand	600118	Lipopeptide compositions and related methods
Japan	6088681
Dominican Republic	P2012000140	COMPUESTOS LIPOPEPTIDOS Y METODOS RELACIONADOS
Brazil	PI0107731	Método para purificar daptomicina
European Patent Office	1115417	UTILISATION DE DAPTOMYCIN (USE OF DAPTOMYCIN)

Supplementary Protection Certificates for CUBICIN RF

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	91254	Luxembourg		91254, EXPIRES: 20210119
1115417	SPC 018/2006	Ireland		SPC 018/2006: 20070523, EXPIRES: 20210118
1115417	300232	Netherlands		DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), VERANDERING VAN DE JURIDISCHE ENTITEIT
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	SZ 22/2006	Austria		PRODUCT NAME: DAPTOMYCIN