CILASTATIN SODIUM; IMIPENEM; RELEBACTAM - Generic Drug Details

What are the generic drug sources for cilastatin sodium; imipenem; relebactam and what is the scope of freedom to operate?

Cilastatin sodium; imipenem; relebactam is the generic ingredient in one branded drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Cilastatin sodium; imipenem; relebactam has seventy-one patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

International Patents:	71
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	CILASTATIN SODIUM; IMIPENEM; RELEBACTAM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Merck Sharp & Dohme Corp.	Phase 3

See all CILASTATIN SODIUM; IMIPENEM; RELEBACTAM clinical trials

Pharmacology for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Drug Class	Penem Antibacterial Renal Dehydropeptidase Inhibitor beta Lactamase Inhibitor
Mechanism of Action	Dipeptidase Inhibitors beta Lactamase Inhibitors

US Patents and Regulatory Information for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes			Y	Y
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes

International Patents for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009091856
Serbia	53052	INHIBITORI BETA-LAKTAMAZE (BETA-LACTAMASE INHIBITORS)
Colombia	6331438	INHIBIDORES DE BETA-LACTAMASA
Hungary	S2000024
Hong Kong	1143809	BETA-LACTAMASE INHIBITORS

Supplementary Protection Certificates for CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2666774	LUC00167	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
2666774	2020024	Norway		PRODUCT NAME: KOMBINASJON AV RELEBAKTAM EVENTUELT I FORM AV MONOHYDRAT, IMIPENEM OG CILASTATIN, EVENTUELT I FORM AV NATRIUMSALT; REG. NO/DATE: EU/1/19/1420 20200219
2231667	C20200021 00336	Estonia		PRODUCT NAME: RELEBAKTAAM;REG NO/DATE: EU/1/19/1420 17.02.2020
2231667	30/2020	Austria		PRODUCT NAME: RELEBACTAM ODER EIN MONOHYDRAT DAVON; REGISTRATION NO/DATE: EU/1/19/1420 (MITTEILUNG) 20200217
2231667	20C1030	France		PRODUCT NAME: RELEBACTAM OU UN MONOHYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1420 20200217